Trial Condition(s):
Sinecort pilot efficacy study (Sinecort Pilot)
13932
Not Available
The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream).
- 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
- 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
Locations | |
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Locations Investigative Site Münster, Germany, 48155 | Contact Us: E-mail: [email protected] Phone: Not Available |
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