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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


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

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