Sinecort Pilot Efficacy Study

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Device: Sinecort cream; Drug: Hydrocortison cream; Other: Untreated skin

• Registration Number: NCT00980135
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Study Start: 2009-11
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2014-03-31
• Status Verified: 2014-04
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Sinecort cream	-
Arm 2	Hydrocortison cream	-
Arm 3	Untreated skin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6	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
Transepidermal water loss (TEWL) as a measure for skin barrier function 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