Cumulative irritation test
Conditions
Interventions
Trade Name: Acanya® Gel
Product Name: Acanya® Gel
Pharmaceutical Form: Gel
INN or Proposed INN: BENZOYL PEROXIDE
CAS Number: 94360
Concentration unit: % percent
Concentration type: equal
Concentrati
Sponsors
Dow Pharmaceutical Sciences, Inc on behalf of Coria Laboratories
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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; •treatment with products containing clindamycin, erythromycin, lincomycin or chloramphenicol within four weeks prior to the first administration of investigational drug in this study and during the study; •treatment with neuromuscular blocking agents within four weeks prior to the first administration of investigational drug in this study and during the study; •known allergy to adhesive on the patches used for occlusion in this study; •treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the beginning of the study and during the study (e.g. antihistamines or glucocorticosteroids); •contraindications according to summary of product characteristics (SmPC) of the test products; •in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent; •subject is an employee or relative of an employee of the investigational site; •subject is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the irritant potential of Acanya® compared to Duac® and BenzaClin®. ;Secondary Objective: Secondary objectives are to assess the irritant potential of Acanya® in combination with a topical retinoid and the irritant potential of Acanya® + Atralin TM compared to Acanya® in combination with Retin-A Micro® 0.04 %, Retin-A Micro® 0.1 %, or Differin® 0.3 %.;Primary end point(s): The primary variable is the clinical assessment of the irritant potential using an score. Erythema reactions are scored once daily for 21 days, except for Sundays. | — |
Countries
Germany
Outcome results
None listed