Clinical trial NCT02060903: A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation
Official title: A Randomized, Double-Blind, Multicenter, Vehicle-Controlled Study of the Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head Lice Infestation
Keywords: Head Lice
Hatchtech
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
Collaborators: name: Accelovance
name: Syneos Health
First posted: 2014-02-12
Enrollment: 379
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This was a randomized, double-blind, multicenter, vehicle-controlled, parallel-group study in subjects with active head lice infestation. The study was designed 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 scalp and hair for 10 minutes at home.

Approximately 106 index subjects with their household members were enrolled into the study. A total of approximately 318 subjects were enrolled, assuming an average of 3 members per household participating in the study.

Eligibility criteria: Inclusion Criteria:

1. Male or female, aged six months of age or older.
2. Is in good general health based on medical history.
3. 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.
4. The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home.
5. Belongs to a household with an eligible index subject with active head lice infestation.
6. Agrees to an examination for head lice and to all visits and procedures throughout the study.
7. Has signed an informed consent and/or assent form.

Exclusion Criteria:

1. Had treatment (over-the-counter ), home remedy or prescription medication) for head lice within 14 days prior to Day 0.
2. Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol.
3. Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol.
4. Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit.
5. Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment.
6. Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data.
7. Has visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is \>2, blisters, vesicles which, in the opinion of the investigative personnel or Sponsor, will interfere with safety and/or efficacy evaluations.
8. Has eczema or atopic dermatitis of skin/scalp.
9. Has had a prior reaction to Nix® or products containing permethrin.
10. Receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
11. Has received an investigational agent within 30 days prior to Day 0.
12. Does not have a known household affiliation with the household members (i.e., does not stay in one household consistently, or sleeps at one place for several nights and then at another place or location).

Primary outcomes:
measure: Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dinuba
country: United States
facility: Universal Biopharma Reserach INC
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: West Palm Beach
country: United States
facility: LSRN Reserach
state: Florida
city: Las Vegas
country: United States
facility: Impact Clinical Trials
state: Nevada
city: Beachwood
country: United States
facility: Haber Dermatology
state: Ohio
city: McKenzie
country: United States
facility: McKenzie Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Radiant reserach Inc.
state: Texas
Study officials:
affiliation: Dr. Reddy's Laboratories Inc.
name: Srinivas Sidgiddi, MD
role: STUDY_DIRECTOR
References: