NCT01082393

Brief Summary

We will investigate the process of vitiligo induction and the influence of different commonly used cream treatments on this process. Studies comparing different treatments for vitiligo in the induction stage of the disease are still missing. The study hypothesis = cream treatment can stop actively spreading vitiligo lesions during the early induction stage of the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2010

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

5.6 years

First QC Date

February 26, 2010

Last Update Submit

December 7, 2022

Conditions

Vitiligo

Keywords

vitiligo

Outcome Measures

Primary Outcomes (1)

  • percentage of skin pigmentation in the treated area

    digital image analysis system for surface measurement

    after 1 day, 10 days, 30 days and 60 days

Study Arms (4)

topical tacrolimus

ACTIVE COMPARATOR
Drug: topical tacrolimus treatment

topical pimecrolimus

ACTIVE COMPARATOR
Drug: topical pimecrolimus treatment

local steroids

ACTIVE COMPARATOR
Drug: local mometasone furoate treatment

cold cream

PLACEBO COMPARATOR
Drug: cold cream

Interventions

topical tacrolimus treatmentDRUG

4 applications (day 1,day 3, day 6 and day10)

topical tacrolimus
topical pimecrolimus treatmentDRUG

4 applications (day 1, day 3, day 6 and day 10)

topical pimecrolimus
local mometasone furoate treatmentDRUG

4 applications (day 1, day 3, day 6 and day 10)

local steroids
cold creamDRUG

4 applications (day 1, day 3, day 6 and day 10)

cold cream

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female,
  • Age 18-70 years,
  • Extensive vitiligo (\> 50% body surface area),
  • Patients asking for depigmenting therapy,
  • Not pregnant.

You may not qualify if:

  • Children,
  • Non extensive vitiligo (\< 50% boy surface area),
  • Patients not asking for depigmenting therapies,
  • Pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nanny Van Geel, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 8, 2010

Study Start

February 16, 2010

Primary Completion

September 15, 2015

Study Completion

December 1, 2015

Last Updated

December 8, 2022

Record last verified: 2022-12

Locations

BE(1)