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Sinecort Pilot Efficacy Study (Sinecort Pilot)

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ClinicalTrials.gov Identifier: NCT00980135
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Device: Sinecort cream Drug: Hydrocortison cream Other: Untreated skin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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.
Study Start Date : November 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Efficacy rate versus comparator and untreated skin [ Time Frame: After 29 days of twice daily applications ]
  2. Local side effects on the skin [ Time Frame: 29 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6 [ Time Frame: after 29 days ]
  3. Skin hydration by means of corneometry at visit 2 through visit 6 [ Time Frame: after 29 days ]
  4. Erythema by means of chromametry at Visit 2 through Visit 6 [ Time Frame: after 29 days ]
  5. 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 ]
  6. Incidence and severity of Adverse Event [ Time Frame: visit 2 (start of dosing period) till 6 weeks after end of treatment ]
  7. Vital signs [ Time Frame: visit1 and 6 weeks after end of treatment ]
  8. Local side effects [ Time Frame: visit 2 (start of dosing period) till 6 weeks after end of treatment ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00980135     History of Changes
Other Study ID Numbers: 13932
2008-008136-82 ( EudraCT Number )
First Posted: September 18, 2009    Key Record Dates
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