This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 19, 2013
Last updated: August 6, 2014
Last verified: August 2014
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
Intervention Model: Parallel Assignment
Masking: Single (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

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • Number of subjects with abnormal vital signs [ Time Frame: Up to 10 weeks ]
    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 ]
  • Erythema by means of chromametry [ Time Frame: Up to 29 days ]
  • Transepidermal water loss (TEWL) as a measure for skin barrier function [ Time Frame: Up to 29 days ]
  • Skin hydration by means of corneometry [ Time Frame: Up to 29 days ]
  • Intensity of pruritus by means of visual analogue scale (VAS) [ Time Frame: Up to 29 days ]

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


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

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 identifier: NCT01948869

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

Additional Information:
Responsible Party: Bayer Identifier: NCT01948869     History of Changes
Other Study ID Numbers: 16960
2013-002569-20 ( EudraCT Number )
Study First Received: September 19, 2013
Last Updated: August 6, 2014

Keywords provided by Bayer:
Mild atopic dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases processed this record on September 21, 2017