check_circleStudy Completed

Dermatitis, Atopic

Bayer Identifier:

16960

ClinicalTrials.gov Identifier:

NCT01948869

EudraCT Number:

2013-002569-20

EU CT Number:

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

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - 60 Years
  • - 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 - Acute symptom of pruritus at Baseline
  • - 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

Trial summary

Enrollment Goal
35
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
Completed
proinnovera GmbHMünster, 48155, Germany

Primary Outcome

  • Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
    date_rangeTime Frame:
    Up to 29 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of subjects 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 patients with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 10 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Erythema by means of chromametry
    date_rangeTime Frame:
    Up to 29 days
    enhanced_encryption
    Safety Issue:
    No
  • Transepidermal water loss (TEWL) as a measure for skin barrier function
    date_rangeTime Frame:
    Up to 29 days
    enhanced_encryption
    Safety Issue:
    No
  • Skin hydration by means of corneometry
    date_rangeTime Frame:
    Up to 29 days
    enhanced_encryption
    Safety Issue:
    No
  • Intensity of pruritus by means of visual analogue scale (VAS)
    date_rangeTime Frame:
    Up to 29 days
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
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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