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

Head Lice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528021
• Other study ID #: BCG20-0582-001
• Status: Completed
• Phase: Phase 2
• Start date: August 2007
• Est. completion date: June 2008

Study information

• Verified date: June 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head Lice
• Lice Infestations
• Parasitic Diseases
• Pediculus Humanus Capitis

Intervention

Drug:
• Placebo
Vehicle Only
• BGC20-0582
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.

Locations

Country	Name	City	State
United States	Global Health Associates of Miami Inc	Florida City	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure	Count of participants with No live lice	Day 15 or 22