NCT02156427CompletedPhase 3
A Multicenter Double-blind Placebo-controlled Trial of Non-cultured Epidermal Cellular Grafting Versus Hyaluronic Acid for Repigmenting Stable Leukoderma (Vitiligo and Piebaldism)
Laboratoires Genévrier5 sites in 3 countries38 target enrollmentStarted: April 29, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 38
- Locations
- 5
- Primary Endpoint
- Rate of successful repigmentation
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy of autologous epidermal cells suspension grafting using a newly developed device named VITICELL® compared to placebo.
The secondary objective is to evaluate safety of VITICELL® and global satisfaction of patient and investigator.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women aged over 18 years old with a diagnosis of non-scaring leukoderma that has been stable over the last 2 years (non-segmental, segmental vitiligo and piebaldism)
- •For non-segmental vitiligo: symmetrical vitiligo lesions, or parts of a lesion. A part of at least 1 cm2 (1 x 1 cm), but preferable 4 cm2 (2x2 cm) and preferably in the center of each lesions (left/right) should be treated.
- •The minimum distance between the normal pigmented skin and the test area should preferably be at least 0.5 cm.
- •For segmental vitiligo lesion and piebaldism: all lesions possible if two parts of at least 1 cm2 (1 x 1 cm), but preferably 4 cm2 (2 x 2 cm) in the lesion can be treated. The minimum distance between the 2 areas should be 2 cm and between test areas and to the normal pigmented skin preferably at least 0.5 cm.
- •Medical treatments of vitiligo failed (in case of vitiligo: at least cream treatment for 6 months).
- •Absence of infected lesion
- •Negative serology (HIV-hepatitis B and C- Syphilis)
- •Without treatment one month for cream and 3 months for phototherapy
Exclusion Criteria
- •Hypersensibility to local anaesthetics or one of the components of the device (trypsin, hyaluronic acid)
- •Indication against biopsies
- •Patient with a history of melanoma
- •Positive serology (ongoing serious systemic disease, herpes, HIV, hepatitis B and C-Syphilis)
- •Positive pregnancy test
- •History of keloidal scars and presence of Koebner's phenomenon (type 1 and type 2b)
- •Infected lesion
- •Test areas not on fingers and toes vitiligo areas in case of non-segmental vitiligo
- •Test areas not on facial non segmental vitiligo
- •Pregnant women, or lactating
- •Age <18years
- •Major deprived of their freedom by administrative or legal decision, or being the subject of a legal protection measure, or out of state to express their consent
Arms & Interventions
VITICELL
Experimental
In this arm, lesions will be treated by autologous epidermal cells suspension (containing hyaluronic acid) obtained after VITICELL kit's use, a class III medical device.
Intervention: VITICELL (Device)
PLACEBO
Placebo Comparator
In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells.
Intervention: PLACEBO (Device)
Outcomes
Primary Outcomes
Rate of successful repigmentation
Time Frame: at month 6
succesful repigementation define as more than or equal to 50% repigmentation of the treated area
Secondary Outcomes
- Rate of successful repigmentation(at month 12)
Investigators
Study Sites (5)
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