Trial Condition(s):
Atopic dermatitis
Sinecort pilot efficacy study (Sinecort Pilot)
Bayer Identifier:
13932
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream).
Inclusion Criteria
- Male or female Caucasians aged between 18 and 65 years - Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25 - Skin type I - IV according to Fitzpatrick - Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12) - 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, 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 Investigative Site Münster, Germany, 48155 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
An investigator-blind, randomized, monocentre, 3-arm, active controlled pilot trial to explore the efficacy and safety of a new topical medical device in patients with mild atopic dermatitis in an intra-individual comparison with a standard therapy (1% Hydrocortisone cream) and untreated skin.
Trial Type:
Interventional
Intervention Type:
Device
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Efficacy rate versus comparator and untreated skinTimeframe: After 29 days of twice daily applications
- Local side effects on the skinTimeframe: 29 days
Secondary Outcome
- Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6Timeframe: after 29 days
- Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6Timeframe: after 29 days
- Skin hydration by means of corneometry at visit 2 through visit 6Timeframe: after 29 days
- Erythema by means of chromametry at Visit 2 through Visit 6Timeframe: after 29 days
- Intensity of pruritus at each day of the dosing period (day 1- day 29) as reported in the patients diary and at Visit 2 through Vist 6 by means of visual analogue scale (VAS)Timeframe: after 29 days
- Incidence and severity of Adverse EventTimeframe: visit 2 (start of dosing period) till 6 weeks after end of treatment
- Vital signsTimeframe: visit1 and 6 weeks after end of treatment
- Local side effectsTimeframe: visit 2 (start of dosing period) till 6 weeks after end of treatment
Additional Information
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