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Sinecort Pilot Efficacy Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00980135
First received: September 16, 2009
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
 Device: Sinecort cream
Drug: Hydrocortison cream
Other: Untreated skin
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Efficacy rate versus comparator and untreated skin [ Time Frame: After 29 days of twice daily applications ] [ Designated as safety issue: No ]
  • Local side effects on the skin [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6 [ Time Frame: after 29 days ] [ Designated as safety issue: No ]
  • Skin hydration by means of corneometry at visit 2 through visit 6 [ Time Frame: after 29 days ] [ Designated as safety issue: No ]
  • Erythema by means of chromametry at Visit 2 through Visit 6 [ Time Frame: after 29 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of Adverse Event [ Time Frame: visit 2 (start of dosing period) till 6 weeks after end of treatment ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: visit1 and 6 weeks after end of treatment ] [ Designated as safety issue: Yes ]
  • Local side effects [ Time Frame: visit 2 (start of dosing period) till 6 weeks after end of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Device: Sinecort cream
Application over 29 days
Experimental: Arm 2 Drug: Hydrocortison cream
Application over 29 days
Arm 3 Other: Untreated skin
n.a

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980135

Locations
Germany
Münster, Nordrhein-Westfalen, Germany, 48155
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Comsumer Care Inc.
ClinicalTrials.gov Identifier: NCT00980135     History of Changes
Other Study ID Numbers: 13932, 2008-008136-82
Study First Received: September 16, 2009
Last Updated: March 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Sinecort
Hydrocortison
Mild atopic dermatitis
Efficacy, safety

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013