Clinical trial NCT00980135: Sinecort Pilot Efficacy Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Sinecort
Hydrocortison
Mild atopic dermatitis
Efficacy, safety
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy rate versus comparator and untreated skin
timeFrame: After 29 days of twice daily applications
measure: Local side effects on the skin
timeFrame: 29 days
Secondary outcomes:
measure: Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6
timeFrame: after 29 days
measure: Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6
timeFrame: after 29 days
measure: Skin hydration by means of corneometry at visit 2 through visit 6
timeFrame: after 29 days
measure: Erythema by means of chromametry at Visit 2 through Visit 6
timeFrame: after 29 days
measure: 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
measure: Incidence and severity of Adverse Event
timeFrame: visit 2 (start of dosing period) till 6 weeks after end of treatment
measure: Vital signs
timeFrame: visit1 and 6 weeks after end of treatment
measure: Local side effects
timeFrame: visit 2 (start of dosing period) till 6 weeks after end of treatment
Other outcomes:
Locations:
city: Münster
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: