stop_circleTerminated/Withdrawn

Dermatitis, Atopic

Bayer Identifier:

16200

ClinicalTrials.gov Identifier:

NCT01691209

EudraCT Number:

2012-001504-38

EU CT Number:

Not Available
Efficacy/safety study to explore a new topical formulation in Atopic Dermatitis

Trial purpose

The study shall explore whether treatment of atopic dermatitis is equally effective with Phoenix medical device as compared to standard therapy (Hydrocortisone cream).

Key Participants Requirements

Sex

Both

Age

18 - 60 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
0
Trial Dates
October 2013 - June 2014
Phase
n/a
Could I Receive a placebo
No
Products
Phoenix (Dexpanthenol, BAY81-2996)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
proinnovera GmbHMünster, 48155, Germany

Secondary Outcome

  • Number of participants with abnormal vital signs
    Vital signs consist of blood pressure, heart rate and body temperature.
    date_rangeTime Frame:
    Up to 10 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 10 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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