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

Bayer0 sites35 target enrollmentOctober 2013

ConditionsDermatitis, Atopic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dermatitis, Atopic
Sponsor: Bayer
Enrollment: 35
Primary Endpoint: Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

June 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

Intensity of pruritus by means of visual analogue scale (VAS)(Up to 29 days)
Number of subjects with abnormal vital signs(Up to 10 weeks)
Erythema by means of chromametry(Up to 29 days)
Transepidermal water loss (TEWL) as a measure for skin barrier function(Up to 29 days)
Skin hydration by means of corneometry(Up to 29 days)
Number of patients with adverse events as a measure of safety and tolerability(Up to 10 weeks)