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Comparative Safety Study of New Sinecort Formulation Versus Positive Control

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00885937
First received: April 21, 2009
Last updated: June 20, 2014
Last verified: June 2014

April 21, 2009
June 20, 2014
April 2009
May 2009   (final data collection date for primary outcome measure)
Irritation rate [ Time Frame: After 21 applications ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00885937 on ClinicalTrials.gov Archive Site
Irritation potential [ Time Frame: After 21 applications ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparative Safety Study of New Sinecort Formulation Versus Positive Control
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.

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: Dexpanthenol (Sinecort, BAY81-2996)
    1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter)
  • Drug: Positive control, Na-laurylsulfat-solution
    50 mikro liter of 0.5 % Sodium-laurylsulfate-solution
  • Device: Untreated skin under application chamber
    Application of treatment chamber as in arm 1 and arm 2 on untreated skin
  • Experimental: Arm 1
    Intervention: Drug: Dexpanthenol (Sinecort, BAY81-2996)
  • Active Comparator: Arm 2
    Intervention: Drug: Positive control, Na-laurylsulfat-solution
  • Placebo Comparator: Arm 3
    Intervention: Device: Untreated skin under application chamber
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00885937
13941, 2008-008138-36, Sinecort
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP