Evaluation of Non-cultured Epidermal Cellular Grafting vs Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism

Phase 3

Completed

• Conditions: Vitiligo; Piebaldism
• Interventions: Device: VITICELL; Device: PLACEBO

• Registration Number: NCT02156427
• Lead Sponsor: Laboratoires Genévrier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-29
• Study First Submitted: 2014-05-30
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-05
• Primary Completion: 2018-04-10
• Study Completion: 2018-04-10
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VITICELL	VITICELL	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.
PLACEBO	PLACEBO	In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells.

Primary Outcome Measures

Name	Time	Method
Rate of successful repigmentation	at month 6	succesful repigementation define as more than or equal to 50% repigmentation of the treated area

Secondary Outcome Measures

Name	Time	Method
Rate of successful repigmentation	at month 12	succesful repigementation define as more than or equal to 50% repigmentation of the treated area

Trial Locations

Locations (5)

Department of Dermatology - Ghent University Hospital; 🇧🇪 Ghent, Belgium

University Hospital Center of Bordeaux; 🇫🇷 Bordeaux, France

CHU Le Mans; 🇫🇷 Le Mans, France

Dr Michel PASCAL; 🇫🇷 Paris, France

San Gallicano Dermatological Institute; 🇮🇹 Roma, Italy