Sinecort Pilot Efficacy Study

Atopic Dermatitis Clinical Trial

— Sinecort Pilot  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980135
• Other study ID #: 13932
• Secondary ID: 2008-008136-82
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2009
• Last updated: March 31, 2014
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• Sinecort cream
Application over 29 days

Drug:
• Hydrocortison cream
Application over 29 days

Other:
• Untreated skin
n.a

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy rate versus comparator and untreated skin		After 29 days of twice daily applications	No
Primary	Local side effects on the skin		29 days	Yes
Secondary	Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6		after 29 days	No
Secondary	Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6		after 29 days	No
Secondary	Skin hydration by means of corneometry at visit 2 through visit 6		after 29 days	No
Secondary	Erythema by means of chromametry at Visit 2 through Visit 6		after 29 days	No
Secondary	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	Yes
Secondary	Incidence and severity of Adverse Event		visit 2 (start of dosing period) till 6 weeks after end of treatment	Yes
Secondary	Vital signs		visit1 and 6 weeks after end of treatment	Yes
Secondary	Local side effects		visit 2 (start of dosing period) till 6 weeks after end of treatment	Yes

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