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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01336647
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : January 19, 2015
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE April 14, 2011
First Posted Date  ICMJE April 18, 2011
Results First Submitted Date  ICMJE December 4, 2013
Results First Posted Date  ICMJE January 19, 2015
Last Update Posted Date April 29, 2020
Study Start Date  ICMJE April 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
Proportion of all subjects who are lice free at all follow-up visits through the Day 14 visit [ Time Frame: 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
Safety and Tolerability of Ha44 Gel [ Time Frame: 14 days ]
The number and percentage of subjects with Treatment emergent AEs (TEAEs) will be reported by treatment group including relationship to study medication. Changes from baseline of Clinical Laboratory results will be summarized across treatment groups. Vital signs, ECG, physical exam findings, and scalp/eye irritation assessment data will be summarized by treatment group. Changes from baseline in these parameters will be summarized across treatment groups at each applicable post-randomization visit.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
Official Title  ICMJE An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
Brief Summary Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pediculosis
Intervention  ICMJE
  • Drug: Group A - Low-Dose Ha44 0.37% w/w
    Low Dose Ha44 Gel applied to scalp and hair for 10 minutes
  • Drug: Group B - High Dose Ha44 Gel 0.74% w/w
    High Dose Ha44 Gel applied to scalp and hair for 10 minutes
  • Drug: Group C - Placebo
    Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes
Study Arms  ICMJE
  • Experimental: Group A
    Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes.
    Intervention: Drug: Group A - Low-Dose Ha44 0.37% w/w
  • 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.
    Intervention: Drug: Group B - High Dose Ha44 Gel 0.74% w/w
  • Placebo Comparator: Group C
    Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.
    Intervention: Drug: Group C - Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2011)
142
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2011)
132
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01336647
Other Study ID Numbers  ICMJE Ha02-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Miguel Restrepo Universal Biopharma Reserach Inc.
Principal Investigator: Lydie Hazan Axis Clinical Trials
PRS Account Dr. Reddy's Laboratories Limited
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP