NCT02061813

Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion

A 21-Day, Randomized, Controlled Study to Evaluate the Irritation Potential of Abametapir Lotion in Healthy Volunteers, Using a Cumulative Irritant Patch Test Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Head Lice

Interventions

Type	Name	Description
DRUG	Abametapir Lotion 0.74% w/w	applied 0.2 mL topically under occlusive condition
DRUG	Sodium Lauryl Sulfate	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.
DRUG	Saline 0.9%	A solution of 0.9% saline for topical administration, applied 21 times over consecutive days under occlusive conditions, will serve as a negative control
DRUG	Placebo

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-01-01
• Completion: 2014-05-01
• First posted: 2014-02-13
• Last updated: 2021-07-26
• Results posted: 2021-07-26

Locations

1 site across 1 country: United States