Comparative Safety Study of New Sinecort Formulation Versus Positive Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Dexpanthenol (Sinecort, BAY81-2996)

Intervention Type DRUG

1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter)

Arm 2

Group Type ACTIVE_COMPARATOR

Positive control, Na-laurylsulfat-solution

Intervention Type DRUG

50 mikro liter of 0.5 % Sodium-laurylsulfate-solution

Arm 3

Group Type PLACEBO_COMPARATOR

Untreated skin under application chamber

Intervention Type DEVICE

Application of treatment chamber as in arm 1 and arm 2 on untreated skin

Interventions

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Dexpanthenol (Sinecort, BAY81-2996)

1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter)

Intervention Type DRUG

Positive control, Na-laurylsulfat-solution

50 mikro liter of 0.5 % Sodium-laurylsulfate-solution

Intervention Type DRUG

Untreated skin under application chamber

Application of treatment chamber as in arm 1 and arm 2 on untreated skin

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes