Comparative Safety Study of New Sinecort Formulation Versus Positive Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00885937
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : June 23, 2014
Information provided by (Responsible Party):

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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.
Study Start Date : April 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00885937

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

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 )
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

Keywords provided by Bayer:
New formulation
Topical administration