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

NCT02156427 | Completed Phase 3 DMC

• 1 other identifier: 13INT/VIT01
• Study Type: interventional
• Target: 38
• Locations: 3 countries
• Sites: 5

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.

Conditions

Vitiligo; Piebaldism

Outcome Measures

Primary Outcomes (1)

• Rate of successful repigmentation

  succesful repigementation define as more than or equal to 50% repigmentation of the treated area

  at month 6

Secondary Outcomes (1)

• Rate of successful repigmentation

  at month 12

Other Outcomes (4)

• Number of adverse events in each group

  Day 0/Day 6-7/Month 3/6/9/12

• Mean reduction of treated area

  Month 3/6/9/12

• Variation of area size

  Day 0/Month 3/6/9/12

Study Arms (2)

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.

Device: VITICELL

PLACEBO

PLACEBO COMPARATOR

In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells.

Device: PLACEBO

Interventions

VITICELL DEVICE

graft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid

VITICELL

PLACEBO DEVICE

hyaluronic acid alone

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoires Genévrier: lead

Study Sites (5)

Department of Dermatology - Ghent University Hospital

Ghent, Belgium

Location

University Hospital Center of Bordeaux

Bordeaux, France

Location

CHU Le Mans

Le Mans, France

Location

Dr Michel PASCAL

Paris, France

Location

San Gallicano Dermatological Institute

Roma, Italy

Location

MeSH Terms

Conditions

Vitiligo; Piebaldism

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Albinism; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Skin Diseases, Genetic; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nanja Van Geel, Pr

  Gent hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, prospective, multicenter, randomised, controlled trial patient is his own control

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 5, 2014
• Study Start: April 29, 2014
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: October 14, 2019

Record last verified: 2019-10

Locations

FR (3); BE (1); IT (1)