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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Dermatitis, Atopic	Device: Phoenix (BAY81-2996); Drug: 1% Hydrocortison cream	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
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 Start Date :	October 2013
Estimated Primary Completion Date :	April 2014
Estimated Study Completion Date :	June 2014

Arms and Interventions

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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

Outcome Measures

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Secondary Outcome Measures :

1. Number of participants with abnormal vital signs [ Time Frame: Up to 10 weeks ]
   Vital signs consist of blood pressure, heart rate and body temperature.
2. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 10 weeks ]

Other Outcome Measures:

1. Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index [ Time Frame: Up to 29 days ]
2. Transepidermal water loss (TEWL) as a measure for skin barrier function [ Time Frame: Up to 29 days ]
3. Skin hydration by means of corneometry [ Time Frame: Up to 29 days ]
4. Erythema by means of chromametry [ Time Frame: Up to 29 days ]
5. Intensity of pruritus by means of visual analogue scale (VAS) [ Time Frame: Up to 29 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Germany
Münster, Nordrhein-Westfalen, Germany, 48155

Sponsors and Collaborators

Bayer

Investigators

Study Director:	Bayer Study Director	Bayer

More Information

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Additional Information:

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Responsible Party:	Head Medical Affairs, Bayer HealthCare AG, Consumer Care
ClinicalTrials.gov Identifier:	NCT01691209 History of Changes
Other Study ID Numbers:	16200; 2012-001504-38 ( EudraCT Number )
First Posted:	September 24, 2012
Last Update Posted:	August 13, 2013
Last Verified:	August 2013

Keywords provided by Bayer:

Phoenix; Hydrocortison; mild atopic dermatitis; efficacy; safety

Additional relevant MeSH terms:

Dermatitis; Dermatitis, Atopic; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate	Hypersensitivity; Immune System Diseases; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Cortisol succinate; Hydrocortisone; Anti-Inflammatory Agents