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

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ClinicalTrials.gov Identifier: NCT01948869
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Dermatitis, Atopic Device: Phoenix II (BAY81-2996) Device: Phoenix I (BAY81-2996) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
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
Study Start Date : October 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arm Intervention/treatment
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



Primary 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 ]

Secondary Outcome Measures :
  1. Number of subjects with abnormal vital signs [ Time Frame: Up to 10 weeks ]
    Vital signs consist of blood pressure, heart rate, and body temperature

  2. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Up to 10 weeks ]
  3. Erythema by means of chromametry [ Time Frame: Up to 29 days ]
  4. Transepidermal water loss (TEWL) as a measure for skin barrier function [ Time Frame: Up to 29 days ]
  5. Skin hydration by means of corneometry [ Time Frame: Up to 29 days ]
  6. Intensity of pruritus by means of visual analogue scale (VAS) [ Time Frame: Up to 29 days ]


Information from the National Library of Medicine

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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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948869


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01948869     History of Changes
Other Study ID Numbers: 16960
2013-002569-20 ( EudraCT Number )
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014

Keywords provided by Bayer:
Phoenix
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