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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Device: Phoenix (BAY81-2996); Drug: 1% Hydrocortison cream

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48155

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phoenix; Application over 29 days twice daily	Device: Phoenix (BAY81-2996); Topical formulation applied to the skin
Active Comparator: Hydrocortison; Application over 29 days twice daily	Drug: 1% Hydrocortison cream; 1% Hydrocortison cream applied to the skin
No Intervention: Untreated skin; Participants will be observed over 29 days without study treatment

What is the study measuring?

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index	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
Erythema by means of chromametry	Up to 29 days
Intensity of pruritus by means of visual analogue scale (VAS)	Up to 29 days

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: September 20, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 9, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: safety; efficacy; Phoenix; Hydrocortison; mild atopic dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: 16200; 2012-001504-38 (EudraCT Number)