Clinical trial NCT01336647: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pediculosis
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 142
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice


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

Primary outcomes:
measure: Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit
timeFrame: Follow up visit at days 1, 7 and 14 days
Secondary outcomes:
measure: Safety and Tolerability of Ha44 Gel
timeFrame: From treatment to last visit of the study at 14 days
Other outcomes:
Locations:
city: Dinuba
country: United States
facility: Universal BioPharma Research Institute, Inc.
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
Study officials:
affiliation: Universal Biopharma Reserach Inc.
name: Miguel Restrepo
role: PRINCIPAL_INVESTIGATOR
affiliation: Axis Clinical Trials
name: Lydie Hazan
role: PRINCIPAL_INVESTIGATOR
References: