Sinecort Pilot Efficacy Study

Bayer

Status and phase

Completed

Phase 2

Conditions

Atopic Dermatitis

Treatments

Device: Sinecort cream

Other: Untreated skin

Drug: Hydrocortison cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT00980135

13932

2008-008136-82 (EudraCT Number)

Details and patient eligibility

About

The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream).

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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