Trial Condition(s):

Atopic dermatitis

Sinecort pilot efficacy study (Sinecort Pilot)

Bayer Identifier:

13932

ClinicalTrials.gov Identifier:

NCT00980135

EudraCT Number:

2008-008136-82

Study Completed

Trial Purpose

The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream).

Inclusion Criteria
- Male or female Caucasians aged between 18 and 65 years
 - Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25
 - Skin type I - IV according to Fitzpatrick
 - Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12)
 - Acute symptom of pruritus at Baseline
Exclusion Criteria
- Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
 - Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
 - Regular intake of antiphlogistic drugs (for example, NSAIDs)
 - Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
 - UV-therapy or the use of solarium within 30 days before screening as well as during the trial
 - Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial

Trial Summary

Enrollment Goal
40
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Dexpanthenol (BAY81-2996)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Münster, Germany, 48155

Status
Completed
 

Trial Design