CompletedPhase 3

Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation

United States325 participantsStarted 2014-02

Plain-language summary

Purpose of this study is to evaluate the efficacy of at-home administration of a single application of abametapir lotion 0.74% w/w for the treatment of head lice.

Who can participate

Age range6 Months

SexALL

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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.
✓. The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home.
✓. Belongs to a household with an eligible index subject with active head lice infestation.
✓. Agrees to an examination for head lice and to all visits and procedures throughout the study.
✓. Has signed an informed consent and/or assent form.

Exclusion criteria

✕. Had treatment (over-the-counter), home remedy or prescription medication) for head lice within 14 days prior to Day 0.
✕. 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.
✕. Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol.
✕. Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit.
✕. Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment.
✕. Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data.
✕. 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.
✕. Has eczema or atopic dermatitis of skin/scalp.

What they're measuring

Proportion of index subjects who are lice-free at all follow-up visits through to the Day 14 visit.

Timeframe: 14 days

Trial details

NCT IDNCT02062060

SponsorDr. Reddy's Laboratories Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-07

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