Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo
| Tracking Information | |||||
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| First Received Date ICMJE | March 15, 2010 | ||||
| Last Updated Date | March 23, 2012 | ||||
| Start Date ICMJE | March 2010 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Lesions that will receive the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy [ Time Frame: 4 months ] [ Designated as safety issue: No ] Opposite side lesions that will received only the treatment by topical steroids and UVB phototherapy |
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| Original Primary Outcome Measures ICMJE |
Lesions that will received the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy [ Time Frame: visit of pre-inclusion; visit of inclusion and the beginning of application of creams (V1); three months of treatment and valuation 1 month after the stopping of treatments ] [ Designated as safety issue: No ] Opposite side lesions that will received only the treatment by topical steroids and UVB phototherapy |
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| Change History | Complete list of historical versions of study NCT01087216 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The treatment of vitiligo remains disappointing especially in some localization such as bony prominences and extremities. The association of UVB and topical steroids has been proven to be synergistic but the results are still insufficient in those difficult to treat areas. Promising results have been shown with the combination of laser assisted dermabrasion, topical 5FU and UVB. The investigators hypothesize that the dermabrasion of vitiligo skin followed by topical steroids should potentialized the effect of UVB and be superior to topical steroids and UVB without dermabrasion. The main objective of this study is to evaluate the usefulness of laser assisted dermabrasion combined to topical steroids and UVB phototherapy in difficult to treat areas. Patients with symmetrical non segmental vitiligo will be included in this prospective randomized monocentrer study. The investigators calculated the number of patients needed at 25. The side that will receive the dermabrasion will be centrally randomized and the opposite side will serve as control. Then on both side class 3 topical steroids will be applied daily 3 weeks on 4 for 12 weeks. UVB phototherapy will be performed twice weekly also for 12 weeks. The evaluation will be performed by two independent physician blinded to the treatment of standardized photos before and 1 month after the end of the treatment. The criteria of success will be at least 75% of repigmentation. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Vitiligo | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | March 2011 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01087216 | ||||
| Other Study ID Numbers ICMJE | 09-PP-08, 2010-A00021-38 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Centre Hospitalier Universitaire de Nice | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Nice | ||||
| Verification Date | March 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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