A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation

Study Overview
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Brief Summary
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The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.

Detailed Description
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The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.

Official Title
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A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation

Conditions
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Pediculus Humanus Capitis, Head Lice

Intervention / Treatment
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* Drug: Placebo
* Drug: BGC20-0582


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent. Male or female subjects who are between the ages of 2 years (24 months) and 70 years old when consent is signed. Infestation with head lice as demonstrated by the presence of live lice prior to first treatment. Willing and able to attend all study visits as scheduled. Females of childbearing potential must have a negative urine pregnancy test at screening and before receiving a second treatment, if necessary. Exclusion Criteria: Subject and/or legal guardian has not signed informed consent. Subject was treated for pediculosis within 2 weeks prior to the screening evaluation. Subject with an infestation of body lice or pubic lice. Subject is suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the investigator and visiting physician could influence the results of the study. Subject with other diagnoses which, in the opinion of the investigator, would interfere with efficacy or safety assessments or would preclude study participation. Subject with very short (shaved) hair. Subject who will not be available for follow up visits. Subject has been treated with a systemic antibiotic within the previous two weeks before screening. Subject has been previously enrolled in any clinical study within the past 30 days; subject may not participate in another study while participating in this study. Subject with history of allergy/sensitivity to active ingredient or related products; or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids. Pregnant and/or nursing females.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. | Drug: BGC20-0582<br>* BGC20-0582 is a topical gel formulation of a naturally derived product. Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or BGC20-0582 at one of the three concentrations. Following application of the BGC20-0582 lice treatment gel of placebo the product is rinsed from the subjects hair.<br>|
| Active Comparator: 2<br>Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. | Drug: BGC20-0582<br>* BGC20-0582 is a topical gel formulation of a naturally derived product. Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or BGC20-0582 at one of the three concentrations. Following application of the BGC20-0582 lice treatment gel of placebo the product is rinsed from the subjects hair.<br>|
| Active Comparator: 3<br>Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 12.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. | Drug: BGC20-0582<br>* BGC20-0582 is a topical gel formulation of a naturally derived product. Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or BGC20-0582 at one of the three concentrations. Following application of the BGC20-0582 lice treatment gel of placebo the product is rinsed from the subjects hair.<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Vehicle Only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure | Count of participants with No live lice | Day 15 or 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head Lice, Lice Infestation, Pediculosis, Pediculosis Capitis