Comparative Safety Study of New Sinecort Formulation Versus Positive Control

Phase 1

Completed

• Conditions: Healthy
• Interventions: Device: Untreated skin under application chamber; Drug: Dexpanthenol (Sinecort, BAY81-2996); Drug: Positive control, Na-laurylsulfat-solution

• Registration Number: NCT00885937
• Lead Sponsor: Bayer

Brief Summary

The study is focused to prove a favorable safety profile of the new formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-20
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 3	Untreated skin under application chamber	-
Arm 1	Dexpanthenol (Sinecort, BAY81-2996)	-
Arm 2	Positive control, Na-laurylsulfat-solution	-

Primary Outcome Measures

Name	Time	Method
Irritation rate	After 21 applications

Secondary Outcome Measures

Name	Time	Method
Irritation potential	After 21 applications