Trial Condition(s):
Dermatitis, Atopic
Efficacy/Safety study to explore a new revised topical formulation in Atopic Dermatitis (Phoenix II)
Bayer Identifier:
16960
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations proinnovera GmbH Münster, Germany, 48155 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD indexTimeframe: Up to 29 days
Secondary Outcome
- Number of subjects with abnormal vital signsVital signs consist of blood pressure, heart rate, and body temperatureTimeframe: Up to 10 weeks
- Number of patients with adverse events as a measure of safety and tolerabilityTimeframe: Up to 10 weeks
- Erythema by means of chromametryTimeframe: Up to 29 days
- Transepidermal water loss (TEWL) as a measure for skin barrier functionTimeframe: Up to 29 days
- Skin hydration by means of corneometryTimeframe: Up to 29 days
- Intensity of pruritus by means of visual analogue scale (VAS)Timeframe: Up to 29 days
Additional Information
Copyright © Bayer
Powered by
