A single center, randomized, controlled study to determine the irritant potential of topical acne formulations on intact healthy skin on the back following repeated application during a 21-day treatment period - Cumulative irritiation test

Dow Pharmaceutical Sciences, Inc on behalf of Coria Laboratories0 sites33 target enrollmentAugust 13, 2009

Overview

No summary available.

Registry

who.int

Start Date

August 13, 2009

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Dow Pharmaceutical Sciences, Inc on behalf of Coria Laboratories

•All of the following criteria have to be met for inclusion of a subject in the study:
•men and women aged 18 years or older;
•healthy skin on which reddening can be easily recognized in the area of the test fields;
•the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
•female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices \[IUDs], sexual abstinence or vasectomized partner.
•written informed consent obtained.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•Subjects are to be excluded from the study when one or more of the following conditions are met:
•acne, suntan, sunburn, eczema, hyperpigmentation or tattoos in the test fields;
•dark\-skinned persons whose skin color prevents ready assessment of skin reactions;
•evidence of drug or alcohol abuse;
•pregnancy or nursing;
•subjects with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic\-associated colitis;
•symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
•participation in the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this study and during the study;
•known allergic reactions or hypersensitivity to any of the components of the study preparations or to lincomycin; known allergy to fish (one study preparation includes soluble fish protein);
•treatment with antiperistaltic agents such as opiates and diphenoxylate with atropine within four weeks prior to the first administration of investigational drug in this study and during the study;