Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation

NCT01907490 | Completed Phase 2 Results

• 1 other identifier: Ha03-004
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of a single application of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions. Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in Ha44 vehicle) under maximal use conditions.

Conditions

Head Lice Infestation

Keywords

Topical treatment of Head Lice Infestation

Outcome Measures

Primary Outcomes (1)

• Number of the Subjects With AEs.

  Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.

  3 months

Secondary Outcomes (3)

• Pk Parameters: Cmax

  0 to 8 hours

• PK Parameters: Tmax

  0-8 hours

• PK Parameters: AUC(0-8)

  0-8 hours

Study Arms (1)

1

EXPERIMENTAL

Ha44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes

Drug: Ha44 Gel

Interventions

Ha44 Gel DRUG

Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair.

Also known as: Benzyl Alcohol

1

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female
• months to 17 years of age
• Be in good health, as determined by medical history and physical examination
• Has an active head lice infestation at screening as determined by an experienced evaluator. An active infestation is defined as the presence of at least 3 live lice.
• Female subjects must be:
• Of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or post-menopausal for at least 2 years) OR,
• If of childbearing potential, must have a negative urine pregnancy test prior to treatment and agree to use a highly effective method of contraception from Day 0 through the Day 14 visit. Acceptable methods of contraception include abstinence, vasectomized partner, tubal ligation, combined oral hormonal contraceptive, contraceptive injection, contraceptive patch, or IUD. If a hormonal contraception is the only method, the subject must have been on a stable dose for at least 3 months.
• The parent/guardian agrees to allow serial blood samples collected from subject for PK analysis during study.
• Has signed an informed consent and/or assent form (ICF).

You may not qualify if:

• Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results.
• Has current dermatological disease or inflammation on the face, scalp, ears, neck or back, including eczema, atopic dermatitis, alopecia, psoriasis or any other chronic skin disease that, in the opinion of the Investigator, would interfere with the safety or PK evaluation.
• Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
• Has been using hormonal contraception for less than 3 months.
• Is pregnant or currently nursing.
• Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results.
• Has received an investigational agent within 30 days prior to Day 0.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead
• Accelovance: collaborator
• Target Health Inc.: collaborator

MeSH Terms

Interventions

Benzyl Alcohol

Intervention Hierarchy (Ancestors)

Benzyl Alcohols; Alcohols; Organic Chemicals; Benzyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Srinivas Sidgiddi
• Organization: Dr. Reddy's Laboratories Inc.

srinivassidgiddi@drreddys.com

9084585362

Study Officials

• Srinivas Sidgiddi, MD

  Dr. Reddy's Laboratories Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 25, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 28, 2020
• Results First Posted: February 9, 2015

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share