A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Dr. Reddy's Laboratories Limited
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of the study was to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home.
Eligibility Criteria
Inclusion Criteria
Male or female, aged six months of age or older.
Is in good general health based on medical history.
Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members.
See 4 more
Treatment Details
Interventions
- Abametapir Lotion 0.74% w/w (Pediculicide)
- Vehicle Lotion (Topical Treatment)
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Abametapir Lotion 0.74% w/wActive Control1 Intervention
Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.
Group II: Vehicle LotionPlacebo Group1 Intervention
Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Impact Clinical TrialsLas Vegas, NV
Axis Clinical TrialsLos Angeles, CA
LSRN ReserachWest Palm Beach, FL
Universal Biopharma Reserach INCDinuba, CA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Dr. Reddy's Laboratories LimitedLead Sponsor
Syneos HealthCollaborator
AccelovanceIndustry Sponsor