NCT01948869CompletedNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Phoenix II
Experimental
Application over 29 days twice daily
Intervention: Phoenix II (BAY81-2996) (Device)
Phoenix I
Active Comparator
Application over 29 days twice daily
Intervention: Phoenix I (BAY81-2996) (Device)
Untreated skin
No Intervention
Untreated skin areas of subjects will be observed over 29 days
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)
Investigators
Study Sites (1)
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