Phase 2
N=50
Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
Head Lice Infestation
Bottom Line
View on ClinicalTrials.gov: NCT02097485 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment — -92.9; -42.3 Percent hatched eggs post versus pre Rx
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abametapir Lotion 0.74% w/w (Drug); Vehicle Lotion (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Dr. Reddy's Laboratories Limited
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment |
-92.9; -42.3 | — |
Summary
The purpose of the study was to evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice.
Eligibility Criteria
Inclusion Criteria
- Healthy male or female based on medical history
- Six months of age or older.
- Has an active head lice infestation with a minimum of 3 live head lice and at least 10 undamaged and unhatched head lice eggs in their hair.
- Agrees to an examination for head lice and compliance with the study procedures.
- All adult subjects must sign a written voluntary informed consent. For minors, the parent/ legal guardian agrees to the subject participating in the study as determined by the signing of an assent of informed consent.
Exclusion Criteria
- Has scalp disease or a history of allergies or prior reactions to any head lice products.
- Has a condition that, in the opinion of the Investigator, may interfere with the study.
- Is receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
- Had treatment (over-the-counter (OTC) or home remedy medication) for head lice within 14 days prior to Day 0.
- Has received an investigational agent within 30 days prior to Day 0.
Data sourced from ClinicalTrials.gov (NCT02097485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.