Comparative Safety Study of New Sinecort Formulation Versus Positive Control
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00885937
First received: April 21, 2009
Last updated: June 13, 2013
Last verified: June 2013
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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
More Information
Additional Information:
No publications provided
| Responsible Party: | Head Clinical Pharmacology, Bayer HealthCare AG |
| 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 13, 2013 |
| 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 June 18, 2013