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Pediculosis capitis or head lice infestation is a worldwide health problem commonly affecting school children. It is caused by an infestation of the arthropod Pediculus humanus capitis. Among the many pediculocidal agents available in the market, the recommended first line drug of choice for treatment of pediculosis capitis are topical pediculicides. Permethrin, a topical synthetic pyrethrin, has effective pediculocidal and ovicidal properties, as it inhibits sodium ion influx through voltage-gated sodium channels leading to delayed neuronal repolarization and death of the parasite. Recently, there has been an emergence of resistance to commonly used over-the-counter pediculocides including permethrin. Also, there is a growing concern about the potential hazards of using pediculocides with a neurotoxic mechanism. The cost of treatment has also been a limitation for treatment especially for those belonging in the lower socioeconomic classes. Since the prevalence and degree of pediculocide resistance is expected to rise, natural alternative treatment for head lice infestations are in demand. There is a need for safer and cheaper therapeutic option that is effective in treating pediculosis capitis. In the search for alternative treatments, in vitro clinical studies of Melia azedarch fruit extracts and oil have demonstrated pediculocide and ovicide effects. It is thus worthwhile to investigate the efficacy of Melia azedarch fruit extract and oil emulsion as an alternative to permethrin. This study therefore aims to compare the efficacy of topically applied Melia azedarch 20% fruit extract and 10% fruit oil with permethrin 5% lotion in the treatment of pediculosis capitis in school children.
II. Relationships of Research Objectives, Data Substrates, Operationally-Defined
Variables and Data Analyses
To compare the pediculocidal cure rate of topically applied Melia azedarch 20%fruit extract and 10% fruit oil versus permethrin 5% lotion in the treatment of pediculosis capitis in children
Data gathering sheet
Cure rate is the proportion of the participants cured of head lice infestation.
Head lice cure is defined as the absence of lice and viable nits on the scalp and hair to be determined by visual inspection and fine tooth combing.
Cure Rate is gathered on on Day 2 (1 day after first treatment), Day 7 (6 days after first treatment), Day 9 (1 day after second treatment), and Day 14 (6 days after second treatment)
To compare the reduction of pruritus severity of topically applied Melia azedarch 20%fruit extract and 10% fruit oil versus permethrin 5% lotion in the treatment of pediculosis capitis in children.
Data gathering sheet for the Pruritus Severity Visual Analogue Scale Score
Pruritus Visual Analogue Score is the scoring sheet to be filled by the participant to evaluate the degree of pruritus
The score will be gathered before treatment, on Day 2 (1 day after first treatment), Day 7 (6 days after first treatment), Day 9 (1 day after second treatment) , and Day 14 (6 days after second treatment)
To compare the reduction of clinical pathology such as presence of erythematous papules, excoriations, and scaling.
Data gathering sheet
Presence of clinical pathology is assessed before treatment. Reduction of the clinical pathology is assessed on Day 2 (1 day after first treatment), Day 7 (6 days after first treatment), Day 9 (1 day after second treatment) , and Day 14 (6 days after second treatment)
Pediculosis capitis is an infestation by the human head louse, Pediculus humanus var. capitis1. These arthropods belong to the phylum Arthropoda, class Insecta, order Phthiraptera, suborder Anoplura, and family Pediculocidae. Their bodies are 1 to 3 mm in length, gray in color, dorsoventrally flattened, and covered with tough chitin. They have three pairs of legs with claw-like talus at the end for grasping hair and clothing2. These do not hop, jump, or fly. They are blood-sucking wingless insects and are highly host-specific, obligate parasites of humans. These are commonly found on the scalp where they take blood meals.
The female louse lays 6 to 8 eggs per day, amounting to about 300 eggs during her lifespan, which is a little over a month3. Their eggs or nits are attached to the hair, particularly on the occipital and retro-auricular regions. Live nits are found near the scalp, usually less than 1 cm from the head because the eggs depend on the warmth and moisture of the scalp for incubation. The eggs are firmly attached to the individual hairs with an adhesive substance. Generally, the eggs located within one-fourth inch of the scalp are unhatched4. The distance of the egg or nit from the scalp along the hair shaft provides an approximate evidence of the duration of the infestation. Nits are small, oval and translucent to white stationary structures making them easily seen by the naked eye during clinical examination.
The louse larva, termed nymph, is a smaller version of the adult louse. Upon hatching, the nymph feeds on the host's blood then undergoes three molting cycles to shed multiple exoskeletons in order to become an adult male or female louse after about 7 to 14 days.
Lice are almost always seen in close proximity to the scalp for food, moisture, warmth, and shelter. These insects can only live up to 2 days away from the scalp. However, there are reports that their life span may last up to 4 days away from the scalp with favourable conditions, while nits can survive up to 10 days away from the scalp5. Lice have a hemi-metabolous life cycle6. They feed on the host's blood every three to six hours. The complex feeding apparatus of lice is comprised of the haustellum, a proboscis-like tube with teeth and a cibarial pump. The teeth of the haustellum anchor it to the host's skin while the lice feed. There are also stylets within the haustellum that help in the blood meal; the two stylets promote infusion of anticoagulant and vasodilator substances7. Temperature can also affect the lice's survival. According to Burkhart and colleagues, nits prefer an environment that is at least 820F with 70% humidity4.
An average host can harbor about 10 to 20 head lice, although less than 5% of patients will have more than 100 adult lice populating the scalp.
Head lice infestation can initially be symptomatic but pruritus of variable severity may be a hallmark of the disease. It is believed that hypersensitivity reaction to the saliva, fecal matter, and body parts causes pruritus. It may take as long as 4 to 6 weeks and up to 3 to 8 months before pruritus can be manifested. Occasionally, a tiny hemorrhagic crust may be found representing a blood meal has taken place5. Furthermore, affected individuals also complain of a tickling feeling or sensation of something moving in the hair, irritability, or lack of sleep. In addition, head lice are a major cause of pyodermas of the scalp, particularly in tropical environments. Trauma due to scratching can lead to pyodermas which in turn may result to matting together of hair as well as cervical and occipital lymphadenopathy. The infestation may also present with excoriations, conjunctivitis, and id reactions8. Some excoriations may occasionally become superinfected with methicillin-resistant Staphylococcus aureus or Streptococcus.
Pediculosis capitis is primarily transmitted via direct contact with an infested person only by relatively prolonged head-to-head contact9. Uncommonly, fomite transmission may involve sharing of head gear such as hats, scarves, coats, combs and brushes, towels, pillows, earphones, beddings, upholstered furniture, and stuffed toys10.
Diagnosis of active head lice infestation relies primarily on the presence of live head lice. Detection of live adult lice, immature nymphs, and viable-appearing eggs confirms the diagnosis of head lice5.
Head lice infestation is a global health problem that warrants attention. Head lice infestation poses the threat of escalating numbers since this highly communicable condition infests millions of people worldwide.
A database completed by Falagas and associates summarized the evidence regarding the worldwide prevalence of pediculosis capitis. Most studies were found to be done in Asia. Head lice prevalence in Asia is varied from 0.7% to 59% compared to 0.48% to 22.4% in Europe and 0% to 58.9% in Africa11. The prevalence in the Americas varied from 3.6% to 61.4%. Most studies referred to school children; however, a number of studies also involved refugees, urban slums, child labourers, street children, jail inmates, orphanage residents, fishing communities, and even the general population.
Head lice are common and it affects all levels of society, all ethnic groups, and all ages, but most especially children. Pediculosis capitis is the most common health problem of public school children4. Head lice infestation is also considered one of the most frequently occurring communicable disease among children. In the United States, an estimate of 6 to 12 million head lice infestations occur annually and head lice infestation generally affects school-aged children12.
Another study by Shakkoury and colleagues showed that pediculosis capitis is most prevalent in school and preschool age groups. Also, they concluded that head lice infestation ranked third in frequency among all skin disorders found in school children in Amman, Jordan.13 Another study by Abdel-Hafez and associates in Egypt stated that infective-parasitic skin diseases are a major problem among the young age group populations in the rural areas and pediculosis capitis is the most common among all of these infestations 14.
Here in the Philippines, a project headed by the Philippine Department of Education Health and Nutrition Center involved a medical examination of 3.376 million public school children in the pre-elementary to the sixth grade, from January to June 2008, it was found out that 436,325 or 13% of the students had pediculosis15. The Philippine Department of Education also commissioned a survey in 2008 which yielded data that ranked pediculosis capitis as the third disease afflicting public school students next to dental and oral problems. A national survey done by the same office in 2004 revealed that among the top 10 common ailments in 11,270, 701 public school children, pediculosis capitis ranked second at 72.2%.
A study by Reyes and colleagues showed that the prevalence of pediculosis capitis among public school children in Muntinlupa City was high, reaching 45.9% of the general population16. The study also concluded that children aged 9 to 10 years old exhibited a significantly lower prevalence rate than those aged 11 years older.
Therapeutic management for pediculosis capitis involves 1 or 2 courses of ovicidal and pediculocidal agents. Classes of treatment agents include the carbamates (carbaryl), organochlorides (lindane), organophosphates (malathion), as well as pyrethrins and pyrethroids (permethrin, D-phenothrin, bioallethrin)5. Studies done by Mumcuoglu states that all pediculocides have failed to attain sufficient lice control17. To date, none of the pediculocides are 100% ovicidal.
A systematic review done by Vander Stichel and associates on the clinical efficacy of topical treatments for head lice showed that permethrin had good evidence of efficacy. Malathion and carbaryl need more evidence of efficacy while lindane and natural pyrethins are not sufficiently effective to justify their use18.
Another study done by Lebowhl and colleagues concluded that the American Academy of Pediatrics highly recommends the use of permethrin as the first line of treatment for head lice 19. Pyrehtrin is an insecticidal compound originating from Chrysanthemum cineriaefolium and permethrin is its synthetic derivative. It has both pediculocidal and ovicidal properties. It blocks the Na channel repolarization mechanism of the insect. The mechanism of action of permethrin against arthropods involves blockage of the Na channel repolarization or inhibition of the organophosphate cholinesterase and γ-aminobutyric acid (GABA) pathways.
Current recommendation on the use permethrin is topical application for 10 minutes on the scalp and washed off after5. The treatment is repeated after 7 to 10 days to kill the recently hatched nymphs and to account for variable ovicidal activity and lack of full patient compliance.
According to an Australian Medicines Evaluation Committee review, adverse events to permethrin occurred at a rate of 2.2 per 1000 treatments as cited by post-marketing surveillance. Majority of these events are pruritus and rash, there were also 5 significant events that reported breathing difficulties, shaking of the arms, and facial edema. Other studies in Australia also concluded a 1.2.to 12.9% incidence of adverse events to permethrin. The Australian Drug Reactions Advisory Committee had documented 16 reports of adverse events from permethrin use. These events include dermal reactions, breathing difficulties, nausea and vomiting, headache, and hair loss. Other reported reactions include burning and stinging sensations, tingling sensations, and numbness 20.
Due to the toxic nature of permethrin, its use is not recommended for children younger than two years old. Also, there are contraindications for using these treatments. These include pregnancy, breastfeeding, respiratory depression, any form of central nervous system pathology including history of seizures, and allergy to chrysanthemums, ragweed, or other related plants.
There is recent evidence of increasing pediculocide resistance worldwide21,22. The resistance of the arthropod to commonly used over-the-counter pediculocides has been demonstrated in numerous in vitro studies1,23,24,25,26,27. The failure to eradicate Pediculosis capitis may be due to the improper use of the medication, reinfestation, or lack of susceptibility to the preparation. Mutations of the insect may have also caused ineffectivity of the treatment.
Permethrin resistance is commonly encountered in developed countries such as the United States, United Kingdom, France, and Australia, where intensive use of chemical instecticides is utilized to combat head lice infestation. Permethrin resistance, coined as knock-down resistance, is mediated by the mutation of the alpha subunit gene of the neuronal voltage-gated sodium channel.
According to Huekelbach and colleagues, the ideal topical head lice should have the following properties: (1) 100% kill of lice, (2) 100% kill of embryos, (3) ability to remove all eggs from the hair shaft, and (4) ability to repel lice. Unfortunately, current pediculocides and ovicides do not fulfill these criteria. The ideal pediculocide should also address the different points in the life cycle. If a treatment protocol, does not kill embryos in the eggs, there is a need for it to be repeated after the lice have hatched, but before the earliest hatched live have matured into adults, mated, and produced a new crop of eggs. Given a narrow window of treatment opportunity to cure an infestation which is about 7 to 10 days, most manufacturers recommended retreatment at day 7 5,28 .
Non-pesticidal therapies include mechanical removal by fine-tooth combing, bug busting, hair shaving, as well as occlusive techniques using petroleum jelly and mayonnaise29,30. Oral medications such as Ivermectin and Co-trimoxazole have also been effective against head lice. Still, others make the use of kerosene and alcohol as remedies which may be potentially hazardous.
The cost of treatment has been a limitation for treatment especially for those belonging in the lower socioeconomic classes. Since the prevalence and degree of pediculocide resistance is expected to rise, alternative treatment options for head lice infestations are needed. Therefore, there is a need for safer and cheaper therapeutic option that is effective in treating head lice.
Herbal plant therapies are of relevance to Dermatology for their beneficial effects on the skin and in treating skin disorders31. The utilization of plant extracts for the treatment of skin diseases has been largely based on historical and anecdotal evidence. Recently, the search and use of indigenous materials as alternative treatment has been the thrust of government programs for providing cheaper medications. In line with this, clinical studies demonstrating the efficacy of these plant extracts are important so as to provide scientific evidence of their therapeutic capabilities.
Traditional medicine abounds with promising plant based-compounds which are effective in the management of ectoparasitic infestations, which include pediculosis. In the search for alternative treatments for human lice infestations, in vitro clinical studies have shown pediculocide and ovicide effects of natural plant extracts and oil. Investigations on paraiso (Melia azedarch), tea tree oil (Melaleuca alternifolia), neem (Azadirachta indica), eucalyptus, anise oil, ref thyme, African tea bush, and cinnamon among others are currently ongoing. These are good potential sources of treatment for controlling human lice since they are effective, specific, low in toxicity, and environment-friendly32.
Melia azedarch, commonly known as Paraiso (Tagalog), Bead tree, Indian lilac, Cape syringa, China berry, or Chinese umbrella tree is a small shrub or a tree33. It is native in the Philippines and is cultivated in larger towns in Manila as an ornamental plant for its fragrant flowers.
Melia azedarch is usually not more than 3 or 4 meters in height. The leaves are bipinnate, occasionally tri-pinnate, 20 to 40 centimeters long. The leaflets are numerous, oblong-ovate, toothed, and 4 to 7 centimeters long. The flowers are fragrant, 5-parted, and borne on panicles 10 to 20 centimeters long. The petals are about 1 centimeter long, oblong spatulate, and pale lilac, while the staminal-tube is usually dark purple and about 7 millimeters long. The fruit is ovoid or subglobose, and about 1 centimeters in length.
Review of Related Literature
An in vitro study done in 2007 in Argentina investigated the pediculicidal and ovicidal activity of Melia azedarach fruit extract and oil. The pediculocidal and ovicidal activities of fruit extract alone, fruit oil alone, and various combinations of fruit extract and oil were compared. Treatments on adult lice with solutions of extract, oil, and combinations of the two displayed significantly higher mortality values, ranging from 62.9% to 96.5%, than the respective control (without treatment). The highest mortality rate was obtained with a combination of 20% ripe fruit extract with 10% ripe fruit oil. It was concluded that the plant demonstrated significant effects on adult lice survival, showed toxicity on lice, and caused detachment of the lice eggs from the hair. There was also complete inhibition of nymph emergence32.
Studies were also conducted to examine the insecticidal mechanism of Melia azedarach fruit extract34,35. These concluded that the fruit extract caused 31% inhibition of the cholinesterase activity and 34% activation of the NADPH-cytochrome c reductase in the insect which may have contributed to its effective insecticide properties.
Another study was performed to isolate and identify the active insecticidal compounds of the fruit extract of Melia azedarch35. The active ingredients were flavonoids, alkaloids, lignans, and triterpenes.
An in vivo clinical trial involving the use of combined Melia azedarch fruit and flowers 10% extract applied topically as an antibacterial agent on children. The results showed that the extracts were comparable to that of Neomycin and no adverse events were reported36.
To date, there has been no known in vivo controlled clinical trials retrieved comparing the pediculocide and ovicidal activity of Melia azedarch fruit extract with a conventional pediculocide.
Will a once a week application of Melia azedarch 20% fruit extract and 10 % fruit oil for 2 weeks cure children with pediculosis capitis compared to a once a week application of Permethrin 5% lotion for 2 weeks?
Significance of the Study
Head lice infestation is not associated with significant health hazards but it brings about social distress, anxiety, and embarrassment. The social cost of missed school days and loss of productivity at work as well as consequences for repeated treatments exaggerate the family's financial burden.
Head lice must not be treated with indifference since there is seriousness in its burden on the patient. Also, in doing so, more relevant issues of increasing treatment resistance and further loss of efficacy may be overlooked. Interconnecting health, financial, and social aspects of pediculosis warrants a more active involvement of health and educational authorities as well as the parents and guardians.
With the development of more efficient and stringent methods and regulations for discovery and improvement of new therapeutic agents, combatting head lice may be enhanced. As the medical community continues to strive for advancement of treatment plans and supervision the eradication of head lice infestation even if over-the counter medications are readily available, the search for effective, safe, and cheaper medications is still needed. Our country is blessed with abundant natural and herbal pediculocidal options. Various literatures have documented the potential of Melia azedarch as an effective pediculocidal agent. To date, there has been no published controlled in vivo clinical trials that test and compare Melia azedarch fruit extract and oil with a conventional pediculocide for head lice cure. The topical therapy, if found effective, may be used as an alternative remedy that is safer, cheaper, and more readily available in the local setting.
Objectives of the Study
The study aims to compare the efficacy and safety of topically applied Melia azedarch 20% fruit extract and 10% fruit oil with permethrin 5% lotion as pediculocidal agent against Pediculosis humanus capitis.
The specific objectives of this study are:
To compare the pediculocidal cure rate of topically applied Melia azedarch 20% fruit extract and 10% fruit oil with permethrin 5% lotion;
2. To compare the efficacy of topically applied Melia azedarch 20% fruit extract and
10% fruit oil with permethrin 5% lotion in terms of the following parameters:
reduction of severity of pruritus
b. reduction of clinical pathology such as erythematous papules, excoriations,
3. To determine adverse events on the use of topically applied Melia azedarch 20%
fruit extract and 10% fruit oil such as eczema, cervical lymphadenopathy, fever,
and secondary bacterial infection.
The study will consist of two phases. Phase I is a pre-testing safety evaluation phase. Phase II of the clinical trial will be a prospective, randomized, investigator-blinded, controlled comparative study on the efficacy and safety of Melia azedarch 20% fruit extract and 10% fruit oil against permethrin 5% lotion as a pediculocidal agent against Pediculosis humanus capitis.
The study will be presented Hospital Research Committee of Southern Philippines Medical Center for approval. In vivo testing will be done at a local elementary school, orphanage, and in a Southern Philippines Medical Center in Davao City.
Participants who will be able to meet the inclusion criteria will be included and individuals with one or more of the exclusion criteria will not be admitted in the study.
Children between the ages of six (6) to fifteen (15) years old diagnosed clinically with pediculosis capitis. To diagnose pediculosis capitis, the scalp and hair of the participants will be screened for the presence of lice and viable nits by partitioning the hair into six (6) areas starting from the frontal region to the occipital area of the head. Survey will be done using the naked eye and magnifying glass under bright artificial light. Finding live lice on the hair and viable eggs that are located on the hair shaft less than 1 cm away from the scalp will confirm the diagnosis
Participants who are willing and able to comply the research protocol
Participants with written informed consent from participant and guardian
Has known sensitivity to any ingredients in the treatment
With any evidence of severe skin disorders of the scalp such as cutaneous bacterial infection (such as pustules and furuncles), erosions, irritation, or sensory defects such as burning or stinging sensation of the scalp
With fever or presence of cervical lymphadenopathy
Use of head lice products, antihelminthics, or antibiotics within the previous four weeks
Use of hair bleach, colour or permanent wave products within the previous four weeks
Diagnosed with mental disease
With drug abuse
Pregnant or lactating females
Participation in another clinical study in the previous month
Participants who will satisfy the criteria and whose parents or guardians will have given their consent will be thoroughly examined by the researcher and will be included in the study.
Interventions and Comparisons
In this study, the test products include Melia azedarch 20% fruit extract and 10% fruit oil emulsion and commercially available permethrin 5% lotion. This is based on the study by Carpinella, et. al that showed a combination of 20% fruit extract and 10% fruit oil has a significant 96.5% success pediculocidal activity rate32.
The Melia azedarch fruit extract and oil will be prepared by a local Herbal Research processing plant. Air-dried, crushed whole ripe Melia azedarach fruits will be extracted with ethanol. After removal of the solvent, an oily viscous extract will be obtained. The oily upper phase (oil) will be separated from the syrup lower phase (extract) after decantation. Both products will be dissolved in distilled water to obtain solutions with the desired concentrations. One drop of emulsifier will be added to oil to ensure complete emulsion in water.
Both preparations will be placed in identical pre-coded containers.
The participants will have equal probabilities of assignment to either Melia azedarch 20% fruit extract and 10% oil or permethrin lotion group. Subjects will be randomized by assigning them with numbers using a computer-generated random list downloaded from the website, www.randomization.com to be done by a co-investigator not involved in the assessment of the outcome measures or analysis of the study.
A research assistant will be assigned in allocating the medication, instructing the patients how to apply it and refilling empty containers upon follow-up. The allocation of the medication will be unknown to both subjects and research investigator.
Phase I: Pre-testing Phase
A pretesting phase will be done on healthy volunteer subjects. This is to assess if any adverse reactions from the Melia azedarch 20% fruit extract and 10% oil will occur on the healthy subjects. The modified repeated open application test (ROAT) will be used. Twenty subjects will apply the Melia azedarch fruit extract and oil in a 5x5 cm2 skin area on the nape close to the posterior hairline. Reading of the test area will be done after 48 and 72 hours. Any adverse reactions such as pruritus, erythema, presence of macules, papules or vesicles, and other symptoms and skin lesions will be noted. Adverse reactions will be graded from mild, moderate, or severe. A total grade of moderate to severe in more than 10% of healthy volunteers will warrant discontinuation of the study.
Phase II: Study Proper
Study participants who will have satisfied the inclusion criteria will be included in phase II of the study. The participants and their parents or guardians will receive written and oral information about the objectives of the study and its possible outcomes and adverse reactions. A written informed consent approved by the Southern Philippines Medical Center Ethics Committee will then be obtained from the participants and their parents or guardians (Appendix).
Baseline demographic data and a complete general physical examination will be done on all the participants on Day 1. A pre-treatment evaluation will be done prior to the in vivo testing. The scalp and hair of the participants will be screened for the presence of live lice by partitioning the head into six areas starting from the frontal region up to the occipital area. Survey will be done with the naked eye and using a magnifying glass under bright artificial light. Also, the scalp will be inspected for any skin disease or irritation. Photographic documentation will also be done to all participants.
The participants who will be confirmed to have head lice will be randomized to receive either topical treatment with the Melia azedarch 20% fruit extract and 10% fruit oil or the permethrin 5% lotion. The test products will be prepared in two identical white coded bottles. The subjects and investigators will be blinded as to the test products applied and the different group assignments. The participants will be assisted by the research assistant during the treatment.
An adequate quantity of both test substances enough to saturate the hair and scalp will be thinly applied directly to dry hair. The treatment will be massaged thoroughly. The application time for participants receiving the Melia azedarch 20% fruit extract and 10% fruit oil will be 1 hour based on the study by Carpinella and associates wherein live lice were exposed to Melia azedarch 20% fruit extract and 10% fruit oil emulsion in vitro for 1 hour and resulted to 96.5% pediculosis capitis mortality32. For participants under the permethrin treatment group, their application time will be 10 minutes as recommended by Wolff, et. al5.
After application, the hair of the participants will be rinsed with clean water and towel dried. The participants will be advised to cleanse their hair with shampoo not containing pediculocide during the study period. Use of fine tooth comb will not be allowed before and after application of the treatment.
The subjects will be treated on the first day and according to the suggestion of a Cochrane Expert Panel, a second time, 7 days later (Day 8) to kill newly hatched lice from eggs which may have survived the first treatment37.
Assessment will be done the following day of treatment (Day 2) and six days after the first treatment (Day 7). A second treatment will be done one week after the first treatment (Day 8), and assessment will be done one day after the second treatment (Day 9), and six days after the second treatment (Day 14). To assess the pediculocidal activity, the scalp and hair of the participants will be again partitioned into six areas from the frontal area to the occipital area. Search for live lice on the hair and viable nits that are seen on the hair shaft less than 1 cm away from the scalp will be done for each of the six scalp and hair areas using the naked eye and a magnifying glass under bright artificial light. After which, fine tooth-combing will be done to confirm presence or absence of lice. A white cloth will be placed below the hair to catch the lice during combing. Combing will be done with three strokes of the hair on each of the six areas of the scalp. Presence or absence of lice and viable nits will be noted.
The severity of the prutitus will be evaluated by the participants using ordinal visual analogue scale ranging from 0 to 4 (Appendix). Presence of clinical pathology such as any scalp lesions or irritation that present as erythematous papules, excoriations, eczema, cutaneous secondary bacterial infection, and presence of fever and cervical lymphadenopathy will be assessed by the investigator. Serial photographic documentation will be performed.
To remove the possibility of reinfestation, other members of the household of all the participants will be given permethrin 5% lotion. They will be instructed to apply the medication on the scalp and hair for ten minutes and perform fine-tooth combing after. Treatment will be done once a week for two weeks for the duration of the study.
For this study, the following are the independent variables: use of non-pediculocidal shampoo and conditioner, non-use of medicinal or cosmetic products, non-use of fine-tooth comb, and treatment of other household members with pediculosis capitis.
Main Outcome Measures and Other Dependent Variables
The primary outcome of the study will be the pediculocidal cure rate, defined as the proportion of participants cured of head lice infestation. It will be obtained as the percentage of subjects without lice and viable nits after visual inspection and fine-tooth combing after treatment with Melia azedarch 20% fruit extract and 10% fruit oil and permethrin 5% lotion on Day 2 (1 day after first treatment), Day 7 (6 days after first treatment), Day 9 (1 day after second treatment), and Day 14 (6 days after second treatment).
The secondary outcomes will be the reduction of severity of pruritus and any of the associated clinical pathologies. The pruritus will be evaluated by the participant using ordinal visual analogue scale ranging from 0 to 4 (Appendix). The reduction of clinical pathologies such as the erythematous papules, excorations, and scaling will be noted. These parameters will also be assessed on Day 2 (1 day after first treatment), Day 7 (6 days after first treatment), Day 9 (1 day after second treatment), and Day 14 (6 days after second treatment).
Sample Size Computation
The study by Carpinella and associates on the pediculocidal and ovicidal activity of Melia azedarch 20% fruit extract and 10% fruit oil showed 96.5% (p=.95) efficacy on head lice cure32. A clinical trial by Huekelbach, et al investigated the pediculocidal activity of dimeticone in comparison with 1% permethrin lotion, this resulted in 66.7% (p=.95) success of permethrin as pediculocidal agent38. Another trial by Hipolito, RB compared 1% permethrin cream against a combination therapy with 1% permethrin and primethoprim/sulfamethoxazole, this showed 79.5% (p=0.795) cure rate of permethrin alone as pediculocidal agent.
Sample size calculation for comparison of proportions using a power of 95% and 87.25% level of significance shows that the estimated minimum sample size required to evaluate the objectives of the study is 56 participants per treatment group (see Appendix for sample computation).
Data Handling and Analysis
To compare the efficacy of Melia azedarch 20% fruit extract and 10% fruit oil in producing pediculocidal efficacy versus permethrin 5% lotion, the chi-quare test will be used in the following parameters:
Pediculocide cure rate
Reduction of associated clinical pathology such as erythematous papules, excoriations, and scaling
This study will be conducted in accordance with the revised Declaration of Helsinki. The research paper will be reviewed and approved by the Research and Ethics Committee of the hospital. Written informed consent will be obtained from the participants and their parents or guardians after having received an information leaflet and after a verbal explanation of the study objectives, the procedure, and the possible adverse reactions of the treatments to be given.
A participant may withdraw from the study anytime at their own request, or they may be withdrawn at anytime at the discretion of the investigator. A subject may be withdrawn prior to the completion of the study for the following reasons:
advserse event such as appearance of eczema or irritation, cutaneous bacterial infections such as pustules or furuncles, fever, and cervical lymphadenopethy
worsening signs of infestation or complications
deviation from the protocol
lost to follow-up
patient, parent or guardian, or physician decision
The participants will be instructed to report to the investigator if there will be note of any adverse reactions or worsening of baseline symptoms and lesions in any time during the study period. They will be asked about any untoward incident during the assessment periods. In case of presence of adverse events, the participant will be withdrawn from the study and immediately given the appropriate standard treatment. The investigator will be responsible for detecting, documenting, and reporting all adverse events.
At the end of the study, free medications will be provided at the end of the clinical trial to the participants considered to be treatment failures.
The results of the intervention will be made confidential and the participants will have the right to withdraw anytime from the study without depriving them of the outcome of the research.
Table 1. Baseline Demographic Characteristics of Participants
Melia azedarch 20% fruit extact and 10% oil emulsion treatment group
Permethrin 5% lotion treatment group
6 to 8
8 to 10
10 to 12
12 to 15
Outside Davao City
Number of people in household
Table 2. Comparison of Cure Rates Between Participants Treated with Melia azedarch
20% Fruit Extract and 10% Oil and Permethrin 5% Lotion
Melia azedarch 20% fruit extract and 10% oil
Permethrin 5% lotion
Cure: defined as compete absence of live lice and viable nits
Table 3. Degree of Pruritus, Assessed by Visual Ordinal Scale from 0 to 4 (Appendix)
Melia azedarch 20% fruit extract and 10% oil
Permethrin 5% lotion
Table 4. Number of Clinical Pathology Detected In Patients Treated with Melia azedarch
20% Fruit Extract and 10% Oil and Permethrin 5% Lotion
Melia azedarch 20% fruit extract and 10% fruit oil
Permethrin 5% lotion
Table 5. Adverse Reactions Detected in the Participants
Melia azedarch 20% fruit extract and 10% fruit oil (n)
Permethrin 5% lotion
TOTAL NUMBER OF ADVERSE EVENTS