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

NCT00528021 | Completed Phase 2 Results

• 1 other identifier: BCG20-0582-001
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediculus Humanus Capitis; Head Lice

Keywords

Head Lice; Lice Infestation; Pediculosis; Pediculosis Capitis

Outcome Measures

Primary Outcomes (1)

• Clinical Cure

  Count of participants with No live lice

  Day 15 or 22

Study Arms (4)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

3

ACTIVE COMPARATOR

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

4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Vehicle Only

4

BGC20-0582 DRUG

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.

1; 2; 3

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Global Health Associates of Miami Inc

Florida City, Florida, 33034, United States

Location

MeSH Terms

Conditions

Lice Infestations

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Jessie Stockwell
• Organization: Boston Scientific Corporation

jessie.stockwell@bsci.com

612-618-1136

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 11, 2007
• Study Start: August 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 28, 2022
• Results First Posted: December 28, 2010

Record last verified: 2022-06

Locations

US (1)