An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation

Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice

Study Overview

• Status: Completed
• Conditions: Pediculosis
• Intervention / Treatment: Drug: Group A - Low-Dose Ha44 0.37% w/w; Drug: Group B - High Dose Ha44 Gel 0.74% w/w; Drug: Group C - Placebo

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Dinuba, California, United States, 93618
      • Universal Biopharma Research Institute, Inc.
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 2 years of age or older
• Body weight of at least 33 pounds
• Has an active head lice infestation at Day 0. An active infection is defined as at least 3 live lice for the index subject and at least 1 live louse for the other household members
• Belong to a household of no more than 6 members, except where additional household members are < 2 years of age
• Belong to a household with an eligible index subject between 2 and 12 years of age with active lice infestation

• 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.

Exclusion Criteria:

• Had treatment for head lice within 14 days prior to Day 0
• Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment
• Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results
• Has an electrocardiographic abnormality, renal disease or impaired renal function, dermatological disease on the face, scalp, ears or neck, or active ophthalmological disease, moderate or severe scleral injection with conjunctival erythema or purulent discharge or allergic or perennial rhinitis requiring chronic treatment
• Has been using hormonal contraception for less than 3 months or is pregnant or lactating
• Has received systemic corticosteroids within 7 days prior to Day 0 or planned while on study
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes.	Drug: Group A - Low-Dose Ha44 0.37% w/w; Low Dose Ha44 Gel applied to scalp and hair for 10 minutes
EXPERIMENTAL: Group B; Group B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration.	Drug: Group B - High Dose Ha44 Gel 0.74% w/w; High Dose Ha44 Gel applied to scalp and hair for 10 minutes
PLACEBO_COMPARATOR: Group C; Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.	Drug: Group C - Placebo; Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit	Follow up visit at days 1, 7 and 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of Ha44 Gel	The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.	From treatment to last visit of the study at 14 days

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Miguel Restrepo, Universal Biopharma Reserach Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: April 14, 2011
• First Submitted That Met QC Criteria: April 14, 2011
• First Posted (ESTIMATE): April 18, 2011

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations
• Other Study ID Numbers: Ha02-003