Healthy
Conditions
Keywords
Dexpanthenol, Safety,, New formulation, Topical administration
Brief summary
The study is focused to prove a favorable safety profile of the new formulation.
Interventions
DRUGDexpanthenol (Sinecort, BAY81-2996)
1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter)
DRUGPositive control, Na-laurylsulfat-solution
50 mikro liter of 0.5 % Sodium-laurylsulfate-solution
DEVICEUntreated skin under application chamber
Application of treatment chamber as in arm 1 and arm 2 on untreated skin
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritation rate | After 21 applications |
Secondary
| Measure | Time frame |
|---|---|
| Irritation potential | After 21 applications |
Countries
Germany
Outcome results
None listed