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

August 6, 2014 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Münster, Nordrhein-Westfalen, Germany, 48155

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
Time Frame: Up to 29 days
Up to 29 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transepidermal water loss (TEWL) as a measure for skin barrier function
Time Frame: Up to 29 days
Up to 29 days
Skin hydration by means of corneometry
Time Frame: Up to 29 days
Up to 29 days
Erythema by means of chromametry
Time Frame: Up to 29 days
Up to 29 days
Intensity of pruritus by means of visual analogue scale (VAS)
Time Frame: Up to 29 days
Up to 29 days
Number of subjects with abnormal vital signs
Time Frame: Up to 10 weeks
Vital signs consist of blood pressure, heart rate, and body temperature
Up to 10 weeks
Number of patients with adverse events as a measure of safety and tolerability
Time Frame: Up to 10 weeks
Up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Estimate)

August 7, 2014

Last Update Submitted That Met QC Criteria

August 6, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16960
  • 2013-002569-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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