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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01948869
First received: September 19, 2013
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Dermatitis, Atopic
Device: Phoenix II (BAY81-2996)
Device: Phoenix I (BAY81-2996)

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, Pilot Trial to Compare the Efficacy and Safety of Two Topical Medical Devices in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With Untreated Skin

Further study details as provided by Bayer:

Primary 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 ]

Secondary Outcome Measures:
  • Number of subjects 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 patients with adverse events as a measure of safety and tolerability [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: Yes ]
  • Erythema by means of chromametry [ 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 ]
  • Intensity of pruritus by means of visual analogue scale (VAS) [ Time Frame: Up to 29 days ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: October 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phoenix II
Application over 29 days twice daily
Device: Phoenix II (BAY81-2996)
Active Comparator: Phoenix I
Application over 29 days twice daily
Device: Phoenix I (BAY81-2996)
No Intervention: Untreated skin
Untreated skin areas of subjects will be observed over 29 days

  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 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

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
  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: NCT01948869

Locations
Germany
Münster, Nordrhein-Westfalen, Germany, 48155
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01948869     History of Changes
Other Study ID Numbers: 16960, 2013-002569-20
Study First Received: September 19, 2013
Last Updated: August 6, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Bayer:
Phoenix
Mild atopic dermatitis
efficacy
safety

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 14, 2014