An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
NCT ID: NCT01336647
Last Updated: 2020-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
142 participants
INTERVENTIONAL
2011-04-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes.
Group A - Low-Dose Ha44 0.37% w/w
Low Dose Ha44 Gel applied to scalp and hair for 10 minutes
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.
Group B - High Dose Ha44 Gel 0.74% w/w
High Dose Ha44 Gel applied to scalp and hair for 10 minutes
Group C
Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.
Group C - Placebo
Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
ALL
No
Sponsors
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Dr. Reddy's Laboratories Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Miguel Restrepo
Role: PRINCIPAL_INVESTIGATOR
Universal Biopharma Reserach Inc.
Lydie Hazan
Role: PRINCIPAL_INVESTIGATOR
Axis Clinical Trials
Locations
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Universal BioPharma Research Institute, Inc.
Dinuba, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Countries
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Other Identifiers
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Ha02-003
Identifier Type: -
Identifier Source: org_study_id
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