check_circleStudy Completed

Healthy

Bayer Identifier:

13941

ClinicalTrials.gov Identifier:

NCT00885937

EudraCT Number:

2008-008138-36

EU CT Number:

Not Available
Comparative safety study of new Sinecort formulation versus positive control

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
33
Trial Dates
April 2009 - May 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Dexpanthenol (BAY81-2996)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
proinnovera GmbHMünster, 48155, Germany

Primary Outcome

  • Irritation rate
    date_rangeTime Frame:
    After 21 applications
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Irritation potential
    date_rangeTime Frame:
    After 21 applications
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Single Blind
Assignment
Single Group Assignment
Trial Arms
3

Additional Information

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