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Comparative Safety Study of New Sinecort Formulation Versus Positive Control

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 21, 2009
Last updated: June 20, 2014
Last verified: June 2014
The study is focused to prove a favorable safety profile of the new formulation.

Condition Intervention Phase
Healthy Drug: Dexpanthenol (Sinecort, BAY81-2996) Drug: Positive control, Na-laurylsulfat-solution Device: Untreated skin under application chamber Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Irritation rate [ Time Frame: After 21 applications ]

Secondary Outcome Measures:
  • Irritation potential [ Time Frame: After 21 applications ]

Enrollment: 33
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Dexpanthenol (Sinecort, BAY81-2996)
1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter)
Active Comparator: Arm 2 Drug: Positive control, Na-laurylsulfat-solution
50 mikro liter of 0.5 % Sodium-laurylsulfate-solution
Placebo Comparator: Arm 3 Device: Untreated skin under application chamber
Application of treatment chamber as in arm 1 and arm 2 on untreated skin


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00885937

Münster, Nordrhein-Westfalen, Germany, 48155
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00885937     History of Changes
Other Study ID Numbers: 13941
2008-008138-36 ( EudraCT Number )
Sinecort ( Other Identifier: Company Internal )
Study First Received: April 21, 2009
Last Updated: June 20, 2014

Keywords provided by Bayer:
New formulation
Topical administration processed this record on September 21, 2017