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

Not Applicable

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Device: Phoenix II (BAY81-2996); Device: Phoenix I (BAY81-2996)

• Registration Number: NCT01948869
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-24
• Study Start: 2013-10
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-06
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phoenix II	Phoenix II (BAY81-2996)	Application over 29 days twice daily
Phoenix I	Phoenix I (BAY81-2996)	Application over 29 days twice daily

Primary Outcome Measures

Name	Time	Method
Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index	Up to 29 days

Secondary Outcome Measures

Name	Time	Method
Intensity of pruritus by means of visual analogue scale (VAS)	Up to 29 days
Number of subjects with abnormal vital signs	Up to 10 weeks	Vital signs consist of blood pressure, heart rate, and body temperature
Erythema by means of chromametry	Up to 29 days
Transepidermal water loss (TEWL) as a measure for skin barrier function	Up to 29 days
Skin hydration by means of corneometry	Up to 29 days
Number of patients with adverse events as a measure of safety and tolerability	Up to 10 weeks