Conditions: Head Lice
Keywords: Hatchtech
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: yes

Brief summary:
The purpose of the study is to determine the irritation potential of repeat applications of abametapir lotion on normal skin.

Detailed description:
This will be a randomized, evaluator-blind, single-center, controlled, within-subject comparison study of the investigational products (abametapir lotion) and its vehicle lotion and positive and negative controls under occlusive conditions in healthy volunteers. All subjects will have the investigational product (abametapir lotion), the vehicle product, the positive control patch, and negative control patch applied to 4 randomly assigned, adjacent skin sites on the infrascapular area of their back, for the purpose of determining irritation potential.

The investigational products, vehicle, and controls will be applied to one side of the infrascapular area of the back. Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation (see Section 3.5.5).

A total of 21 applications of each product will be made.

Arms:
arm 1: Applied 0.2 mL topically under occlusive condition arm 2: Applied 0.2 mL topically under occlusive condition arm 3: Positive control applied 0.2 mL topically under occlusive condition arm 4: Negative control applied 0.2 mL topically under occlusive condition

Interventions: intervention 1: Abametapir Lotion 0.74% w/w intervention 2: Sodium Lauryl Sulfate intervention 3: Saline 0.9% intervention 4: Placebo
Intervention descriptions: intervention 1: applied 0.2 mL topically under occlusive condition intervention 2: Sodium Lauryl Sulfate is prepared as a 0.2% aqueous solution by the site for topical administration, and applied 21 times over consecutive days under occlusive conditions, will serve as a positive control. intervention 3: A solution of 0.9% saline for topical administration, applied 21 times over consecutive days under occlusive conditions, will serve as a negative control intervention 4: None

Protocol document: