Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis - Full Text View

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:

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone butyrate Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC

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 ]


Enrollment:	0
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691209

Locations


Germany

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:	August 9, 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 Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic	Cortisol succinate Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone-17-butyrate Anti-Inflammatory Agents Dermatologic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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