Comparative Safety Study of New Sinecort Formulation Versus Positive Control

Bayer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Device: Untreated skin under application chamber; Drug: Dexpanthenol (Sinecort, BAY81-2996); Drug: Positive control, Na-laurylsulfat-solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00885937

2008-008138-36 (EudraCT Number)

13941

Sinecort (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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33 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Dexpanthenol (Sinecort, BAY81-2996)

Arm 2

Active Comparator group

Treatment:

Drug: Positive control, Na-laurylsulfat-solution

Arm 3

Placebo Comparator group

Treatment:

Device: Untreated skin under application chamber