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

• ClinicalTrials.gov Identifier: NCT02156427
• Recruitment Status: Completed
• First Posted: June 5, 2014
• Last Update Posted: October 14, 2019
• Sponsor: Laboratoires Genévrier
• Information provided by (Responsible Party): Laboratoires Genévrier

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vitiligo; Piebaldism	Device: VITICELL; Device: PLACEBO	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double-blind, prospective, multicenter, randomised, controlled trial patient is his own control
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter Double-blind Placebo-controlled Trial of Non-cultured Epidermal Cellular Grafting Versus Hyaluronic Acid for Repigmenting Stable Leukoderma (Vitiligo and Piebaldism)
• Actual Study Start Date: April 29, 2014
• Actual Primary Completion Date: April 10, 2018
• Actual Study Completion Date: April 10, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: VITICELL; graft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid
Placebo Comparator: PLACEBO; In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells.	Device: PLACEBO; hyaluronic acid alone

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Rate of successful repigmentation [ Time Frame: at month 12 ]
   succesful repigementation define as more than or equal to 50% repigmentation of the treated area

Other Outcome Measures:

1. Number of adverse events in each group [ Time Frame: Day 0/Day 6-7/Month 3/6/9/12 ]
2. Mean reduction of treated area [ Time Frame: Month 3/6/9/12 ]
   calculated in pourcentage from baseline
3. Variation of area size [ Time Frame: Day 0/Month 3/6/9/12 ]
   Size in cm² measured at each visit
4. Patient and physician satisfaction [ Time Frame: Month12 ]
   Likert scale ranging from 1 to 5 (1=Not at all satisfied / 2=Slightly satisfied / 3=Moderately satisfied / 4=Very satisfied / 5=Extremely satisfied).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Belgium

Department of Dermatology - Ghent University Hospital

Ghent, Belgium

France

University Hospital Center of Bordeaux

Bordeaux, France

CHU Le Mans

Le Mans, France

Dr Michel PASCAL

Paris, France

Italy

San Gallicano Dermatological Institute

Roma, Italy

Sponsors and Collaborators

Laboratoires Genévrier

Investigators

• Principal Investigator: Nanja Van Geel, Pr; Gent hospital

More Information

• Responsible Party: Laboratoires Genévrier
• ClinicalTrials.gov Identifier: NCT02156427
• Other Study ID Numbers: 13INT/VIT01
• First Posted: June 5, 2014
• Last Update Posted: October 14, 2019
• Last Verified: October 2019

Additional relevant MeSH terms:

Piebaldism; Vitiligo; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Albinism; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Skin Diseases, Genetic; Metabolic Diseases