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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082393
First Posted: March 8, 2010
Last Update Posted: December 5, 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):
University Hospital, Ghent
  Purpose
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
Vitiligo 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 (Participant, 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)

  Eligibility

Information from the National Library of Medicine

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

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
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): NCT01082393


Contacts
Contact: Nanny Van Geel, MD, PhD nanny.vangeel@ugent.be

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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01082393     History of Changes
Other Study ID Numbers: 2009/599
First Submitted: February 26, 2010
First Posted: March 8, 2010
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
vitiligo

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Tacrolimus
Pimecrolimus
Mometasone Furoate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents