Efficacy/Safety Study to Explore a New Revised Topical Formulation in Atopic Dermatitis (Phoenix II)

Bayer

Status: Completed

Conditions: Dermatitis, Atopic

Treatments: Device: Phoenix I (BAY81-2996); Device: Phoenix II (BAY81-2996)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01948869

2013-002569-20 (EudraCT Number)

16960

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 3 patient groups

Phoenix II

Experimental group

Description:

Application over 29 days twice daily

Treatment:

Device: Phoenix II (BAY81-2996)

Phoenix I

Active Comparator group

Description:

Application over 29 days twice daily

Treatment:

Device: Phoenix I (BAY81-2996)

Untreated skin

No Intervention group

Description:

Untreated skin areas of subjects will be observed over 29 days