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
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Irritation rate [ Time Frame: After 21 applications ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Irritation potential [ Time Frame: After 21 applications ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885937

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00885937     History of Changes
Other Study ID Numbers: 13941, 2008-008138-36, Sinecort
Study First Received: April 21, 2009
Last Updated: June 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Dexpanthenol
Safety,
New formulation
Topical administration

ClinicalTrials.gov processed this record on October 19, 2014