Trial Condition(s):

Dermatitis, Atopic

Efficacy/Safety study to explore a new revised topical formulation in Atopic Dermatitis (Phoenix II)

Bayer Identifier:

16960

ClinicalTrials.gov Identifier:

NCT01948869

EudraCT Number:

2013-002569-20

Study Completed

Trial Purpose

The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.

Inclusion Criteria
- Male or female Caucasians aged between 18 and 60 years
 - Patients with mild to moderate AD (Atopic Dermatitis) presenting a scoring AD (SCORAD) rating below 50
 - Skin type I – IV according to Fitzpatrick
 - Acute AD symptoms on each assessment areas  (local SCORAD ≥ 3 and </= 12) at Baseline
 - 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, nonsteroidal anti-inflammatory drug [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
35
Trial Dates
black-arrow
Phase
n/a
Could I receive a placebo?
No
Products
Phoenix (Dexpanthenol, BAY81-2996)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

proinnovera GmbH

Münster, Germany, 48155

Status
Completed
 

Trial Design