Clinical trial NCT01691209: Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: Phoenix
Hydrocortison
mild atopic dermatitis
efficacy
safety
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
measure: Number of participants with abnormal vital signs
timeFrame: Up to 10 weeks
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 10 weeks
Other outcomes:
measure: Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
timeFrame: Up to 29 days
measure: Transepidermal water loss (TEWL) as a measure for skin barrier function
timeFrame: Up to 29 days
measure: Skin hydration by means of corneometry
timeFrame: Up to 29 days
measure: Erythema by means of chromametry
timeFrame: Up to 29 days
measure: Intensity of pruritus by means of visual analogue scale (VAS)
timeFrame: Up to 29 days
Locations:
city: Münster
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: