Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Head Lice

Clinical Trial Details

NCT number	NCT02061813
Study type	Interventional
Source	Dr. Reddy's Laboratories Limited
Contact
Status	Completed
Phase	Phase 1
Start date	January 2014
Completion date	May 2014

View Details

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