A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
Condition: Pediculus Humanus Capitis; Head Lice
MeSH terms: Lice Infestations; Parasitic Diseases
Intervention: Placebo; BGC20-0582
Intervention description: Vehicle Only; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 230.0
Sex: All
Minimum age: 2 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Head Lice; Lice Infestation; Pediculosis; Pediculosis Capitis

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          1. The subject and/or his/her parent/legal guardian have provided written informed
             consent, and, if appropriate, the child has provided assent.

          2. Male or female subjects who are between the ages of 2 years (24 months) and 70 years
             old when consent is signed.

          3. Infestation with head lice as demonstrated by the presence of live lice prior to first
             treatment.

          4. Willing and able to attend all study visits as scheduled.

          5. Females of childbearing potential must have a negative urine pregnancy test at
             screening and before receiving a second treatment, if necessary.

        Exclusion Criteria:

          1. Subject and/or legal guardian has not signed informed consent.

          2. Subject was treated for pediculosis within 2 weeks prior to the screening evaluation.

          3. Subject with an infestation of body lice or pubic lice.

          4. 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.

          5. Subject with other diagnoses which, in the opinion of the investigator, would
             interfere with efficacy or safety assessments or would preclude study participation.

          6. Subject with very short (shaved) hair.

          7. Subject who will not be available for follow up visits.

          8. Subject has been treated with a systemic antibiotic within the previous two weeks
             before screening.

          9. 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.

         10. 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.

         11. Pregnant and/or nursing females.