Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis

Condition(s) targeted: Dermatitis, Atopic

Intervention: Phoenix (BAY81-2996) (Device); 1% Hydrocortison cream (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Secondary outcome:

Number of participants with abnormal vital signs

Number of participants with adverse events as a measure of safety and tolerability

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Münster, Nordrhein-Westfalen 48155, Germany

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Starting date: October 2013
Last updated: August 9, 2013