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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: February 26, 2010
Last updated: December 4, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Drug: topical tacrolimus treatment
Drug: topical pimecrolimus treatment
Drug: local mometasone furoate treatment
Drug: cold cream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • percentage of skin pigmentation in the treated area [ Time Frame: after 1 day, 10 days, 30 days and 60 days ]
    digital image analysis system for surface measurement

Estimated Enrollment: 10
Study Start Date: February 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: topical tacrolimus Drug: topical tacrolimus treatment
4 applications (day 1,day 3, day 6 and day10)
Active Comparator: topical pimecrolimus Drug: topical pimecrolimus treatment
4 applications (day 1, day 3, day 6 and day 10)
Active Comparator: local steroids Drug: local mometasone furoate treatment
4 applications (day 1, day 3, day 6 and day 10)
Placebo Comparator: cold cream Drug: cold cream
4 applications (day 1, day 3, day 6 and day 10)


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01082393

University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Principal Investigator: Nanny Van Geel, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent Identifier: NCT01082393     History of Changes
Other Study ID Numbers: 2009/599 
Study First Received: February 26, 2010
Last Updated: December 4, 2014

Keywords provided by University Hospital, Ghent:

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases
Mometasone Furoate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on February 20, 2017