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:
University Hospital, Ghent
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
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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 Endpoint Classification: Efficacy Study 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:
Genetics Home Reference related topics:
vitiligo
MedlinePlus related topics:
Vitiligo
Drug Information available for:
Mometasone furoate
Tacrolimus
Pimecrolimus
Mometasone furoate monohydrate
U.S. FDA Resources
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 ] [ Designated as safety issue: Yes ]digital image analysis system for surface measurement
| Estimated Enrollment: | 10 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01082393 History of Changes |
| Other Study ID Numbers: | 2009/599 |
| Study First Received: | February 26, 2010 |
| Last Updated: | February 1, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board |
Keywords provided by University Hospital, Ghent:
|
vitiligo |
Additional relevant MeSH terms:
|
Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Mometasone furoate Pimecrolimus Tacrolimus Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antirheumatic Agents Dermatologic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013