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

Pediculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336647
• Other study ID #: Ha02-003
• Status: Completed
• Phase: Phase 2
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2020
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: March 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lice Infestations
• Pediculosis

Intervention

Drug:
• Group A - Low-Dose Ha44 0.37% w/w
Low Dose Ha44 Gel applied to scalp and hair for 10 minutes
• Group B - High Dose Ha44 Gel 0.74% w/w
High Dose Ha44 Gel applied to scalp and hair for 10 minutes
• Group C - Placebo
Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes

Locations

Country	Name	City	State
United States	Universal BioPharma Research Institute, Inc.	Dinuba	California
United States	Axis Clinical Trials	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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