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| Name | Class |
|---|---|
| ARIV Onlus | UNKNOWN |
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The purpose of this study is to evaluate the hypothesis that, in patients with stable vitiligo unresponsive to conventional treatments including traditional phototherapy and/or topical steroids, the application of a non-cultured autologous hair follicle outer-root-sheath melanocytes suspension in the area affected by the disease followed by targeted ultraviolet B (UVB) phototherapy can lead to a significant skin repigmentation. To assess the effect of the proposed treatment, a within-subject controlled study involving selected symmetric lesion areas localized to the back of the hands will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outer-Root-Sheath Melanocytes Suspension | Experimental | This arm includes all patients sides (left or right) treated with autologous outer-root-sheath melanocytes suspension followed by targeted UVB phototherapy |
|
| Placebo | Placebo Comparator | This arm includes all patients sides (left or right) treated with placebo followed by targeted UVB phototherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outer-Root-Sheath Melanocytes Suspension | Biological | The treatment consists in depositing a suspension of autologous outer-root-sheath melanocytes, derived from patient's plucked hair follicles, and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week). |
| Measure | Description | Time Frame |
|---|---|---|
| Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Any repigmentation of the treated areas from baseline as assessed by physician according to an ordinal 6-points scale | 6 weeks, 12 weeks | |
| Any repigmentation of the treated areas from baseline as assessed by patient according to an ordinal 6-points scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Naldi, MD | Centro Studi Gised | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papa Giovanni XXIII Hospital | Bergamo | 24127 | Italy | |||
| Spedali Civili |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| Placebo | Biological | The treatment consists in depositing a solution made of saline and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week). |
|
| 6 weeks, 12 weeks |
| Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale | 6 weeks, 12 weeks |
| Any repigmentation of the treated areas from baseline as assessed by image analysis | 6 weeks, 12 weeks |
| Any repigmentation of other areas affected by vitiligo from baseline as assessed by physician according to an ordinal 6-points scale (evaluation of a possible systemic effect) | 6 weeks, 12 weeks |
| Brescia |
| 25123 |
| Italy |