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Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01082393
First received: February 26, 2010
Last updated: February 1, 2013
Last verified: February 2013
History of Changes

February 26, 2010
February 1, 2013
February 2010
December 2013   (final data collection date for primary outcome measure)
percentage of skin pigmentation in the treated area [ Time Frame: after 1 day, 10 days, 30 days and 60 days ] [ Designated as safety issue: Yes ]
digital image analysis system for surface measurement
Same as current
Complete list of historical versions of study NCT01082393 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)
Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)

We will investigate the process of vitiligo induction and the influence of different commonly used cream treatments on this process. Studies comparing different treatments for vitiligo in the induction stage of the disease are still missing. The study hypothesis = cream treatment can stop actively spreading vitiligo lesions during the early induction stage of the disease.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Vitiligo
  • Drug: topical tacrolimus treatment
    4 applications (day 1,day 3, day 6 and day10)
  • Drug: topical pimecrolimus treatment
    4 applications (day 1, day 3, day 6 and day 10)
  • Drug: local mometasone furoate treatment
    4 applications (day 1, day 3, day 6 and day 10)
  • Drug: cold cream
    4 applications (day 1, day 3, day 6 and day 10)
  • Active Comparator: topical tacrolimus
    Intervention: Drug: topical tacrolimus treatment
  • Active Comparator: topical pimecrolimus
    Intervention: Drug: topical pimecrolimus treatment
  • Active Comparator: local steroids
    Intervention: Drug: local mometasone furoate treatment
  • Placebo Comparator: cold cream
    Intervention: Drug: cold cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female,
  • Age 18-70 years,
  • Extensive vitiligo (> 50% body surface area),
  • Patients asking for depigmenting therapy,
  • Not pregnant.

Exclusion Criteria:

  • Children,
  • Non extensive vitiligo (< 50% boy surface area),
  • Patients not asking for depigmenting therapies,
  • Pregnant.
Both
18 Years to 70 Years
No
Contact: Nanny Van Geel, MD, PhD nanny.vangeel@ugent.be
Belgium
 
NCT01082393
2009/599
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Nanny Van Geel, MD, PhD University Hospital, Ghent
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP