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

Not Applicable

Withdrawn

• Conditions: Dermatitis, Atopic
• Interventions: Drug: 1% Hydrocortison cream; Device: Phoenix (BAY81-2996)

• Registration Number: NCT01691209
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-24
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-13
• Study Start: 2013-10
• Primary Completion: 2014-04
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocortison	1% Hydrocortison cream	Application over 29 days twice daily
Phoenix	Phoenix (BAY81-2996)	Application over 29 days twice daily