An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
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|ClinicalTrials.gov Identifier: NCT01336647|
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : January 19, 2015
Last Update Posted : April 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pediculosis||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||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||March 2012|
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
- 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 ]
- Safety and Tolerability of Ha44 Gel [ Time Frame: From treatment to last visit of the study at 14 days ]The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336647
|United States, California|
|Universal BioPharma Research Institute, Inc.|
|Dinuba, California, United States, 93618|
|Axis Clinical Trials|
|Los Angeles, California, United States, 90036|
|Principal Investigator:||Miguel Restrepo||Universal Biopharma Reserach Inc.|
|Principal Investigator:||Lydie Hazan||Axis Clinical Trials|