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

Dr.Reddy's Laboratories

Status and phase: Completed; Phase 2

Conditions: Pediculosis

Treatments: 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01336647

Ha02-003

Details and patient eligibility

About

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

Enrollment: 142 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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142 participants in 3 patient groups, including a placebo group

Group A

Experimental group

Description:

Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes.

Treatment:

Drug: Group A - Low-Dose Ha44 0.37% w/w

Group B

Experimental group

Description:

Group B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration.

Treatment:

Drug: Group B - High Dose Ha44 Gel 0.74% w/w

Group C

Placebo Comparator group

Description:

Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.

Treatment:

Drug: Group C - Placebo