Back to resultsAn Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
Primary Purpose
Pediculosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Group A - Low-Dose Ha44 0.37% w/w
Group B - High Dose Ha44 Gel 0.74% w/w
Group C - Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pediculosis
Eligibility Criteria
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
Sites / Locations
- Universal BioPharma Research Institute, Inc.
- Axis Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes.
Group B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration.
Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.
Outcomes
Primary Outcome Measures
Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01336647
First Posted
April 14, 2011
Last Updated
April 27, 2020
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT01336647
Brief Title
An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
Official Title
An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.
Intervention Type
Drug
Intervention Name(s)
Group A - Low-Dose Ha44 0.37% w/w
Intervention Description
Low Dose Ha44 Gel applied to scalp and hair for 10 minutes
Intervention Type
Drug
Intervention Name(s)
Group B - High Dose Ha44 Gel 0.74% w/w
Intervention Description
High Dose Ha44 Gel applied to scalp and hair for 10 minutes
Intervention Type
Drug
Intervention Name(s)
Group C - Placebo
Intervention Description
Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes
Primary Outcome Measure Information:
Title
Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit
Time Frame
Follow up visit at days 1, 7 and 14 days
Secondary Outcome Measure Information:
Title
Safety and Tolerability of Ha44 Gel
Description
The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.
Time Frame
From treatment to last visit of the study at 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Restrepo
Organizational Affiliation
Universal Biopharma Reserach Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lydie Hazan
Organizational Affiliation
Axis Clinical Trials
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universal BioPharma Research Institute, Inc.
City
Dinuba
State/Province
California
ZIP/Postal Code
93618
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
We'll reach out to this number within 24 hrs