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

NCT01336647 | Completed Phase 2 Results DMC

• 1 other identifier: Ha02-003
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pediculosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety and Tolerability of Ha44 Gel

  From treatment to last visit of the study at 14 days

Study Arms (3)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Group C

PLACEBO COMPARATOR

Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.

Drug: Group C - Placebo

Interventions

Group A - Low-Dose Ha44 0.37% w/w DRUG

Low Dose Ha44 Gel applied to scalp and hair for 10 minutes

Group A

Group B - High Dose Ha44 Gel 0.74% w/w DRUG

High Dose Ha44 Gel applied to scalp and hair for 10 minutes

Group B

Group C - Placebo DRUG

Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes

Group C

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (2)

Universal BioPharma Research Institute, Inc.

Dinuba, California, 93618, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

MeSH Terms

Conditions

Lice Infestations

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Manager
• Organization: Hatchtech Pty Ltd

tahveninen@hatchtech.com.au

+61 3 9092 0490

Study Officials

• Miguel Restrepo

  Universal Biopharma Reserach Inc.

  PRINCIPAL INVESTIGATOR

• Lydie Hazan

  Axis Clinical Trials

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 18, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 29, 2020
• Results First Posted: January 19, 2015

Record last verified: 2020-04

Locations

US (2)