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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02010333
Other study ID # Ha03-003
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2013
Est. completion date August 2014

Study information

Verified date May 2020
Source Dr. Reddy's Laboratories Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date August 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender All
Age group 6 Months to 2 Years
Eligibility Inclusion Criteria:

1. Male or female, 6months < 3years of age

2. Good health

3. Active head lice infestation defined as the presence of at least 3 live lice

4. Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)

5. Parent/guardian agrees to allow PK samples collected

6. Signed Informed Consent Form

Exclusion Criteria:

1. Condition or illness that in the opinion of the investigator may interfere with the study results.

2. Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.

3. Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.

4. Receiving systemic or topical medication that may interfere the study results.

5. Received an investigational agent within 30 days prior to Day 0.

Study Design


Intervention

Drug:
Ha44 Gel 0.74% w/w
HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.

Locations

Country Name City State
United States Universal Biopharma Research Institute 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 Safety and tolerability of Ha44 Gel Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events. 8 months
See also
  Status Clinical Trial Phase
Completed NCT02097485 - Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation Phase 2
Recruiting NCT04878276 - Comparative Head Lice Therapy With Dimet 5® vs. Hedrin® Once
Completed NCT01907490 - Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation Phase 2
Completed NCT02062060 - Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation Phase 3
Completed NCT02060903 - A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation Phase 3
Recruiting NCT06057506 - Comparative Study for the Evaluation of Two Medical Devices on the Treatment of Head Lice Infestation N/A