VitiligoPhase 4KoebnerNCT01082393
Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)
A Phase 4 study testing topical tacrolimus treatment, topical pimecrolimus treatment and local mometasone furoate treatment in people with Vitiligo, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- topical tacrolimus treatment, topical pimecrolimus treatment and local mometasone furoate treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Feb 2010to 1 Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female,
- Age 18-70 years,
- Extensive vitiligo (> 50% body surface area),
- Patients asking for depigmenting therapy,
- Not pregnant.
Who cannot join
- Children,
- Non extensive vitiligo (< 50% boy surface area),
- Patients not asking for depigmenting therapies,
- Pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Vitiligo
- Being tested
- topical tacrolimus treatment, topical pimecrolimus treatment, local mometasone furoate treatment, cold cream
- Keywords
- vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical tacrolimus treatmentDrug
4 applications (day 1,day 3, day 6 and day10)
topical pimecrolimus treatmentDrug
4 applications (day 1, day 3, day 6 and day 10)
local mometasone furoate treatmentDrug
4 applications (day 1, day 3, day 6 and day 10)
cold creamDrug
4 applications (day 1, day 3, day 6 and day 10)
| Study group | Role | What they receive |
|---|---|---|
| topical tacrolimus | Active comparator | Not described Receives: Drug: topical tacrolimus treatment |
| topical pimecrolimus | Active comparator | Not described Receives: Drug: topical pimecrolimus treatment |
| local steroids | Active comparator | Not described Receives: Drug: local mometasone furoate treatment |
| cold cream | Placebo comparator | Not described Receives: Drug: cold cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of skin pigmentation in the treated area
digital image analysis system for surface measurement
Measured: after 1 day, 10 days, 30 days and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study start16 Feb 2010
- Primary completion15 Sep 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nanny Van Geel, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082393
- Sponsor's protocol ID
- 2009/599
- Acronym
- Koebner
- Status last verified
- Dec 2022
- First submitted
- 26 Feb 2010
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)
- ClinicalTrials.gov ID
- NCT01082393
- Acronym / sponsor ID
- Koebner / 2009/599
- Conditions
- Vitiligo
- Keywords
- vitiligo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 16 Feb 2010 (actual)
- Primary completion
- 15 Sep 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 8 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female,
- Age 18-70 years,
- Extensive vitiligo (> 50% body surface area),
- Patients asking for depigmenting therapy,
- Not pregnant.
Key exclusion criteria (4 listed)
- Children,
- Non extensive vitiligo (< 50% boy surface area),
- Patients not asking for depigmenting therapies,
- Pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical tacrolimus treatment4 applications (day 1,day 3, day 6 and day10) | Drug | topical tacrolimus |
| topical pimecrolimus treatment4 applications (day 1, day 3, day 6 and day 10) | Drug | topical pimecrolimus |
| local mometasone furoate treatment4 applications (day 1, day 3, day 6 and day 10) | Drug | local steroids |
| cold cream4 applications (day 1, day 3, day 6 and day 10) | Drug | cold cream |
Primary outcome
percentage of skin pigmentation in the treated area
Time frame: after 1 day, 10 days, 30 days and 60 days
digital image analysis system for surface measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nanny Van Geel, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing topical tacrolimus treatment, topical pimecrolimus treatment and local mometasone furoate treatment in people with Vitiligo, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of skin pigmentation in the treated area (time frame: after 1 day, 10 days, 30 days and 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.