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

This study is not yet open for participant recruitment.
Verified May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01691209
First received: September 20, 2012
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention
Dermatitis, Atopic
 Device: Phoenix (BAY81-2996)
Drug: 1% Hydrocortison cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Secondary Outcome Measures:
  • Number of participants with abnormal vital signs [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: Yes ]
    Vital signs consist of blood pressure, heart rate and body temperature.

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index [ Time Frame: Up to 29 days ] [ Designated as safety issue: No ]
  • Transepidermal water loss (TEWL) as a measure for skin barrier function [ Time Frame: Up to 29 days ] [ Designated as safety issue: No ]
  • Skin hydration by means of corneometry [ Time Frame: Up to 29 days ] [ Designated as safety issue: No ]
  • Erythema by means of chromametry [ Time Frame: Up to 29 days ] [ Designated as safety issue: No ]
  • Intensity of pruritus by means of visual analogue scale (VAS) [ Time Frame: Up to 29 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: October 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691209

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Germany
Not yet recruiting
Münster, Nordrhein-Westfalen, Germany, 48155
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: September 20, 2012
Last Updated: May 3, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Phoenix
Hydrocortison
mild atopic dermatitis
efficacy
safety

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013