Comparative Safety Study of New Sinecort Formulation Versus Positive Control

Study Overview
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Brief Summary
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The study is focused to prove a favorable safety profile of the new formulation.

Official Title
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Single-blind, Randomized, Controlled, Single Center Trial to Evaluate the Skin Irritation Potential of a New Topical Formulation by Means of an Occlusive Patch Test in Healthy Subjects.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Dexpanthenol (Sinecort, BAY81-2996)
* Drug: Positive control, Na-laurylsulfat-solution
* Device: Untreated skin under application chamber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of at least 18 years Skin type I, II, or III according to Fitzpatrick Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception. Exclusion Criteria: Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the products or the ingredients of the products including the patch. Known skin allergies. Dermatologic diseases that might interfere with the evaluation of test site reaction. Other(s), considered as important by the investigator (e.g. multiple birth marks in the test area, important hair growth in the test area, pigmented or extremely suntanned skin impairing visual assessment, tattoos in the test area. Topical use of any cosmetic preparation on the test areas within 5 days prior to Day 1 (Start of Treatment) or during the trial Within 3 weeks prior to Day 1 and during the entire trial. Any systemic or topical medication likely to interfere with the trial purposes: e.g. immune-modulating therapy (e.g. corticosteroids, cytotoxics or immunosuppressants) and any dermatological medication (drug or medical device. Within 1 week prior to Day 1 and during the entire trial any medication with common effects on the perfusion of skin vessels (e.g. vasodilators or vasoconstrictors, ß-receptor blocking drugs, antihistamines) should not be used.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Dexpanthenol (Sinecort, BAY81-2996)<br>* 1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter)<br>|
| Active Comparator: Arm 2<br> | Drug: Positive control, Na-laurylsulfat-solution<br>* 50 mikro liter of 0.5 % Sodium-laurylsulfate-solution<br>|
| Placebo Comparator: Arm 3<br> | Device: Untreated skin under application chamber<br>* Application of treatment chamber as in arm 1 and arm 2 on untreated skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritation rate |  | After 21 applications | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritation potential |  | After 21 applications | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexpanthenol, Safety,, New formulation, Topical administration