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Sinecort Pilot Efficacy Study (Sinecort Pilot)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00980135
First Posted: September 18, 2009
Last Update Posted: April 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


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 ]
  • Local side effects on the skin [ Time Frame: 29 days ]

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 ]
  • Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6 [ Time Frame: after 29 days ]
  • Skin hydration by means of corneometry at visit 2 through visit 6 [ Time Frame: after 29 days ]
  • Erythema by means of chromametry at Visit 2 through Visit 6 [ Time Frame: 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) [ Time Frame: after 29 days ]
  • Incidence and severity of Adverse Event [ Time Frame: visit 2 (start of dosing period) till 6 weeks after end of treatment ]
  • Vital signs [ Time Frame: visit1 and 6 weeks after end of treatment ]
  • Local side effects [ Time Frame: visit 2 (start of dosing period) till 6 weeks after end of treatment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980135


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00980135     History of Changes
Other Study ID Numbers: 13932
2008-008136-82 ( EudraCT Number )
First Submitted: September 16, 2009
First Posted: September 18, 2009
Last Update Posted: April 2, 2014
Last Verified: April 2014

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

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