Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO (Rapid Vitiligo)
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ClinicalTrials.gov Identifier: NCT03036995 |
Recruitment Status :
Completed
First Posted : January 31, 2017
Last Update Posted : December 4, 2019
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Tracking Information | |||||
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First Submitted Date ICMJE | January 6, 2017 | ||||
First Posted Date ICMJE | January 31, 2017 | ||||
Last Update Posted Date | December 4, 2019 | ||||
Actual Study Start Date ICMJE | March 20, 2017 | ||||
Actual Primary Completion Date | November 8, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Score VASI [ Time Frame: at 24 weeks ] Efficacy will be evaluated using the Vitiligo Area Scoring Index (VASI)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO | ||||
Official Title ICMJE | Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO RAPID VITILIGO | ||||
Brief Summary | Vitiligo is a depigmentation disorder affecting 0.5 to 2% of the general population. It is an acquired pigmentary disorder of the skin and mucous membranes that is characterized by circumscribed, depigmented macules and patches. Apremilast is a phosphosdiesterase 4 (PDE4) inhibitor that showed efficacy and very good tolerance in rheumatoid arthritis and psoriasis. Apremilast induces a potent activation of the cyclic AMP (cAMP) pathway leading to anti-inflammatory effect by decreasing the response of Th1 and Th17 lymphocytes. Interestingly, the cAMP pathway is also well demonstrated to be the main pathway for promoting melanogenesis and for inducing the differentiation and the proliferation of melanocytes. The principal aims is to compare, after 24 weeks of treatment, the efficacy of Apremilast at the label dosage in combination therapy with narrow band UVB versus placebo therapy with narrow band UVB for repigmentation in patients with non-segmental vitiligo. Patients with non-segmental vitiligo with BSA > 10% and patient with Vitiligo stable or slowly progressive for 3 months , seeking for treatment in the Department of Dermatology, University Hospital of Nice, France will be recruited into the study. The Patients are seen in consultation by the investigator, selection criteria are checked. All patients will receive full body narrow UVB treatment, twice weekly sessions of narrow UVB for 24 weeks. From W24 to W48
Observational Follow-up Phase - W48 to W52 Four-week Observational Follow-up Phase for all subjects who complete the study (responders and non responders) or discontinue the study early. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Vitiligo | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Khemis A, Fontas E, Moulin S, Montaudie H, Lacour JP, Passeron T. Apremilast in Combination with Narrowband UVB in the Treatment of Vitiligo: A 52-Week Monocentric Prospective Randomized Placebo-Controlled Study. J Invest Dermatol. 2020 Aug;140(8):1533-1537.e2. doi: 10.1016/j.jid.2019.11.031. Epub 2020 Jan 29. | ||||
* 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 | ||||
Actual Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | November 25, 2019 | ||||
Actual Primary Completion Date | November 8, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03036995 | ||||
Other Study ID Numbers ICMJE | 16-PP-06 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Centre Hospitalier Universitaire de Nice | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Centre Hospitalier Universitaire de Nice | ||||
Verification Date | December 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |