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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 November 2016 |
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Main ID: |
NCT02962180 |
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Date of registration:
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09/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Transplantation of Basal Cell Layer Suspension Using Derma-rolling System in Vitiligo
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Scientific title:
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Transplantation With Dermarolling System of Basal Cell Layer Suspension Obtained by Soft Trypsinisation in Vitiligo Lesion |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02962180 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Morocco
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Contacts
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Name:
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laila benzekri, PhD |
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Address:
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Telephone:
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212671964111 |
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Email:
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benzekrilaila@yahoo.fr |
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Affiliation:
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Name:
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LAILA BENZEKRI, PhD |
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Address:
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Telephone:
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212671964111 |
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Email:
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benzekrilaila@yahoo.fr |
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Affiliation:
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Name:
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laila benzekri |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mohammed V University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Non segmental and segmental vitiligo lesions stable for a minimum of 1 year prior
surgery
- Men and women aged over 18 years of age
- The lesion area must be 2cm2< lesion< 15cm2
- Absence of infected lesion
Exclusion Criteria:
- Actively spreading vitiligo (unstable disease)
- Patient with history of melanoma
- Infected lesions
- Positive Koebner Phenomenon
- History of hypertrophic scars or keloid formation
- Treatment with immunosuppressive or cytotoxic medication the past year
- Pregnant women and patients aged less 18 years
- Patients with concomitant photosensitizing treatment
- Positive serology of herpes, HIV, hepatitis B and C
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Vitiligo
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Intervention(s)
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Device: Dermabrasion with dermaroller
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Primary Outcome(s)
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Rate of repigmentation lesions
[Time Frame: At 6 months]
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Secondary Outcome(s)
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Global satisfaction expressed by the patient
[Time Frame: At 6 months]
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Secondary ID(s)
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MOHAMMED V UNIVERSITY
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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