Sinecort Pilot Efficacy Study

Bayer40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Sinecort creamDEVICE

Application over 29 days

Hydrocortison creamDRUG

Application over 29 days

Untreated skinOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Münster, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Efficacy rate versus comparator and untreated skin

Time frame: After 29 days of twice daily applications

Local side effects on the skin

Time frame: 29 days

Secondary Outcomes

Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6

Time frame: after 29 days

Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6

Time frame: after 29 days

Skin hydration by means of corneometry at visit 2 through visit 6

Time frame: after 29 days

Erythema by means of chromametry at Visit 2 through Visit 6

Time frame: 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)

Time frame: after 29 days

Incidence and severity of Adverse Event

Time frame: visit 2 (start of dosing period) till 6 weeks after end of treatment

Vital signs

Time frame: visit1 and 6 weeks after end of treatment

Local side effects

Time frame: visit 2 (start of dosing period) till 6 weeks after end of treatment

Data from ClinicalTrials.gov

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