NCT01629979

Brief Summary

The effects of treatment of transplantation of harvested autologous epidermal cells on vitiligo lesions followed by narrow-band UVB will be investigated in a randomized controlled study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

1.5 years

First QC Date

March 23, 2012

Last Update Submit

May 29, 2013

Conditions

VITILIGO

Outcome Measures

Primary Outcomes (1)

  • Repigmentation rate at 12 months

    Repigmentation rate at 12 months

    12months

Secondary Outcomes (1)

  • Repigmentation > 70% at 12 months

    12 months

Study Arms (2)

A: Grafting of autologous epidermal harvested cells and UVB

EXPERIMENTAL

Grafting with epidermal cells: A superficial skin shaving excision will be obtained from pigmented skin using a dermatome. A cell suspension will be obtained by trypsinisation. Vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. The cell suspension will be spread on the dermabraded skin area and fixed with dressings. Keratinocyte, and melanocyte counts will be performed on an aliquot of the cell suspension. One symmetrical patch of vitiligo will be chosen as control and left untreated. Narrow-band UVB treatment: Four weeks after transplantation of epidermal cells, the grafted and control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.

Procedure: Grafting with epidermal cells

UVB treatment

ACTIVE COMPARATOR

UVB treatment twice a week during 3months

Radiation: UVB treatment

Interventions

Grafting with epidermal cellsPROCEDURE

A superficial skin shaving excision will be obtained from pigmented skin using a dermatome. A cell suspension will be obtained by trypsinisation. Vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. The cell suspension will be spread on the dermabraded skin area and fixed with dressings. Keratinocyte, and melanocyte counts will be performed on an aliquot of the cell suspension. One symmetrical patch of vitiligo will be chosen as control and left untreated. Narrow-band UVB treatment: Four weeks after transplantation of epidermal cells, the grafted and control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.

A: Grafting of autologous epidermal harvested cells and UVB
UVB treatmentRADIATION

the control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.

UVB treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18yr
  • Stable vitiligo (no lesion since 12 mo)
  • symmetrical vitiligo patches of at least 10 cm2
  • Vitiligo requiring UVB treatment
  • Women using a contraceptive

You may not qualify if:

  • History of keloids
  • History of skin cancer
  • Photosensitivity
  • Positive blood test for HIV, HBV, HVC, or HTLV1
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier Universitaire de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Transplantation

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • philippe bahadoran, doctor

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2012

First Posted

June 28, 2012

Study Start

May 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations

FR(1)