Terminated/Withdrawn

Dermatitis, Atopic

Bayer Identifier:

16200

ClinicalTrials.gov Identifier:

NCT01691209

EudraCT Number:

2012-001504-38

EU CT Number:

Not Available

Efficacy/safety study to explore a new topical formulation in Atopic Dermatitis

Trial purpose

The study shall explore whether treatment of atopic dermatitis is equally effective with Phoenix medical device as compared to standard therapy (Hydrocortisone cream).

Key Participants Requirements

Sex

Both

Age

18 - 60 Years

Inclusion Criteria
- Male or female Caucasians aged between 18 and 60 years
- Patients with mild atopic dermatitis (AD) 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 with the clinical assessment in the opinion of the investigator
- Moles, tattoos, strong pigmentation, or scars at the test area that would interfere with the clinical assessment
- Regular intake of antiphlogistic drugs (for example nonsteroidal anti-inflammatory drugs [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

Trial Dates

October 2013 - June 2014

Phase

n/a

Could I Receive a placebo

Products

Phoenix (Dexpanthenol, BAY81-2996)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Terminated	proinnovera GmbH	Münster, 48155, Germany

Secondary Outcome

Number of participants with abnormal vital signs
Vital signs consist of blood pressure, heart rate and body temperature.
Time Frame:
Up to 10 weeks
Safety Issue:
Yes
Number of participants with adverse events as a measure of safety and tolerability
Time Frame:
Up to 10 weeks
Safety Issue:
Yes

Trial design

An investigator-blinded, randomized, monocentre, 3-arm, active controlled pilot trial to explore the efficacy and safety of a topical medical device in patients with mild to moderate atopic dermatitis in an intra-individual comparison with a standard therapy (1% Hydrocortisone cream) and untreated skin

Trial Type

Interventional

Intervention Type

Device

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Single Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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