- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02510651
Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo
Effect of Procedural-Related Variables on Melanocyte-Keratinocyte Suspension Transplantation in Non-Segmental Stable Vitiligo: A Clinical and Immunohistochemical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Melanocyte-keratinocyte suspension (M-K susp) is gaining popularity for vitiligo treatment. Few studies have addressed procedure-related variables.
Objective: To assess the effect of different M-K susp procedure-related variables on the clinical outcome in stable vitiligo.
Methods: This retrospective study included 40 cases with stable non-segmental vitiligo treated by M-K susp followed by narrow band- ultraviolet B phototherapy twice weekly. Donor site was either a skin graft in non-cultured epidermal cell suspension (NCECS) (34 cases) or hair follicle unit in Outer Root Sheath Hair Follicle Suspension (ORSHFS) (6 cases). Recipient site was prepared by either cryoblebbing (24 cases) or carbon dioxide (CO2)laser resurfacing (16 cases). Cell counts and viability were recorded in the cell suspensions, and tissue melanocytes and keratinocytes were examined by Melan A and Cytokeratin respectively. Assessment of repigmentation was done 18 months after the procedure.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Stable non-segmental vitiligo
Exclusion Criteria:
- Active vitiligo
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ORSHFS
Melanocyte-keratinocyte suspension.
|
Treatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of patients with satisfactory response after the surgical procedure for vitiligo.
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAH555
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitiligo
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PfizerRecruitingStable Nonsegmental Vitiligo | Active Nonsegmental VitiligoUnited States, Spain, Australia, Mexico, Canada, China, Japan, Italy, Turkey, Korea, Republic of, Germany, South Africa, Poland, United Kingdom, Bulgaria
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PfizerRecruitingStable Nonsegmental Vitiligo | Active Nonsegmental VitiligoJapan, Canada, China, United States
-
Fundació Institut de Recerca de l'Hospital de la...Completed
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Incyte CorporationRecruitingNonSegmental VitiligoGermany, United States, Italy, Poland, Canada, France, Bulgaria, Hungary, United Kingdom
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Incyte CorporationCompletedNonSegmental VitiligoUnited States, Canada
-
Cairo UniversitySuspended
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Assiut UniversityUnknown
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University of TorontoCanadian Interdisciplinary Network Complementary & Alternative Medicine ResearchCompleted
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University Hospital, GhentNovartisCompletedVitiligo VulgarisBelgium
Clinical Trials on Melanocyte-keratinocyte suspension
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Henry Ford Health SystemWithdrawn
-
Assiut UniversityUnknownBurn With Full-Thickness Skin Loss
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Assiut UniversityWithdrawn
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Henry Ford Health SystemUnknownVitiligo | Depigmented Scars | DepigmentationUnited States
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Centre Hospitalier Universitaire VaudoisCompleted
-
Avita MedicalTerminated
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Biosolution Co., Ltd.UnknownBurn WoundKorea, Republic of
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Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnMalignant Neoplasm | Gastrointestinal Mucositis
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National Taiwan University HospitalNational Science Council, Taiwan; National Health Research Institutes, TaiwanUnknownVitiligo | MelanocyteTaiwan