Clinical trial NCT01923142: Efficacy of Autologous Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo
Official title: Double Blind Within-Subject Controlled Study of Autologous Hair Follicle Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vitiligo
Keywords: Vitiligo
Outer-Root-Sheath
Melanocytes
Hair Follicles
Lead sponsor: Centro Studi Gised
Sponsor class: OTHER
Collaborators: name: ARIV Onlus
First posted: 2013-08-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Presence of symmetric lesions of vitiligo at the back of the hands with an extension \>5cm²
* Vitiligo lasting at least one year at the backs of both hands
* Stable vitiligo, defined as vitiligo that presents no evident evolution (appearance of new lesions or increase in the extension of lesions already present) for at least 6 months
* Suspension for at least two months prior to the enrollment date of any systemic drug for vitiligo such as immunosuppressive treatment (cyclosporine, systemic steroids) or psoralen + ultraviolet A therapy, phototherapy with ultraviolet B, and of any anticoagulant drug
* Suspension of topical medications for at least 15 days prior to the enrollment date

Exclusion Criteria:

* Presence of active vitiligo or Koebner phenomenon
* Difference of more than 10% in the extension of symmetrical areas of vitiligo
* Presence of systemic infections or infections localized to the tissues intended for transplantation
* History of infections to the tissues intended for transplantation (herpes simplex, human papillomavirus infections, pityriasis versicolor, pityriasis alba)
* Presence or history of malignancy
* Chemotherapy or radiation therapy in progress
* History of allergies or adverse reactions to local anesthetics
* Presence of transmissible diseases (human immunodeficiency virus, hepatitis B and C, human T-lymphotropic virus type I and II, syphilis, cytomegalovirus, Creutzfeldt-Jacob, tuberculosis)
* Women who are pregnant or intend to become pregnant during the study period (including breastfeeding women)

Primary outcomes:
measure: Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis
timeFrame: 12 weeks
Secondary outcomes:
measure: Any repigmentation of the treated areas from baseline as assessed by physician according to an ordinal 6-points scale
timeFrame: 6 weeks, 12 weeks
measure: Any repigmentation of the treated areas from baseline as assessed by patient according to an ordinal 6-points scale
timeFrame: 6 weeks, 12 weeks
measure: Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale
timeFrame: 6 weeks, 12 weeks
measure: Any repigmentation of the treated areas from baseline as assessed by image analysis
timeFrame: 6 weeks, 12 weeks
measure: 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)
timeFrame: 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Papa Giovanni XXIII Hospital
city: Brescia
country: Italy
facility: Spedali Civili
Study officials:
affiliation: Centro Studi Gised
name: Luigi Naldi, MD
role: PRINCIPAL_INVESTIGATOR
References: