Atopic Dermatitis
Conditions
Keywords
Sinecort, Hydrocortison, Mild atopic dermatitis, Efficacy, safety
Brief summary
The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream).
Interventions
DEVICESinecort cream
Application over 29 days
DRUGHydrocortison cream
Application over 29 days
OTHERUntreated skin
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate versus comparator and untreated skin | After 29 days of twice daily applications |
| Local side effects on the skin | 29 days |
Secondary
| Measure | Time frame |
|---|---|
| Skin hydration by means of corneometry at visit 2 through visit 6 | after 29 days |
| Erythema by means of chromametry at Visit 2 through Visit 6 | 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) | after 29 days |
| Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6 | after 29 days |
| Vital signs | visit1 and 6 weeks after end of treatment |
| Local side effects | visit 2 (start of dosing period) till 6 weeks after end of treatment |
| Incidence and severity of Adverse Event | visit 2 (start of dosing period) till 6 weeks after end of treatment |
| Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6 | after 29 days |
Countries
Germany
Outcome results
None listed