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

Boston Scientific

Status and phase: Completed; Phase 2

Conditions: Head Lice; Pediculus Humanus Capitis

Treatments: Drug: BGC20-0582; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528021

BCG20-0582-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 230 patients

Sex: All

Ages: 2 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

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.

Treatment:

Drug: BGC20-0582

2

Active Comparator group

Description:

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.

Treatment:

Drug: BGC20-0582

3

Active Comparator group

Description:

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.

Treatment:

Drug: BGC20-0582

4

Placebo Comparator group

Treatment:

Drug: Placebo