CompletedPhase 2

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

United States230 participantsStarted 2007-08

Plain-language 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.

Age range2 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Clinical Cure

Timeframe: Day 15 or 22

NCT IDNCT00528021

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-05

Results submitted2009-02-20

Who can participate

Age range2 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.