Sinecort Pilot Efficacy Study

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

Official Title
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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.

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Device: Sinecort cream
* Drug: Hydrocortison cream
* Other: Untreated skin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Device: Sinecort cream<br>* Application over 29 days<br>|
| Experimental: Arm 2<br> | Drug: Hydrocortison cream<br>* Application over 29 days<br>|
| Other: Arm 3<br> | Other: Untreated skin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6 |  | after 29 days | 
| Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6 |  | after 29 days | 
| 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 | 
| Incidence and severity of Adverse Event |  | visit 2 (start of dosing period) till 6 weeks after end of treatment | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinecort, Hydrocortison, Mild atopic dermatitis, Efficacy, safety