Pigmentation DisordersPhase 2/3NCT01841008
Maintenance Treatment of Non Segmental Vitiligo With Tacrolimus Ointment 0.1% Versus Control
A Phase 2/3 study testing Protopic in people with Pigmentation Disorders and Vitiligo, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Tacrolimus ointment 0.1% has shown promising results for treating vitiligo in many prospective studies. Prospective randomized studies versus placebo are required to confirm the hypothesis that maintenance treatment with two applications of tacrolimus ointment 0.1% per week can reduce relapses of non-segmental… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pigmentation Disorders, Vitiligo
- What is being tested?
- Protopic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2011to Jun 2014
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Non-segmental vitiligo repigmented more than 75% with treatment (any type of treatment is accepted: NB-UVB, PUVA, lamp or excimer laser at 308 nm, topical steroids, topical tacrolimus, graft). The total area treated plates during maintenance treatment should not exceed 10% of the total body surface area.
- Affiliation to the Social Security
- Informed consent signed by the patient
Who cannot join
- Segmental Vitiligo
- Pregnant or breastfeeding women (pregnancy test will be conducted); effective contraception will be maintained for the duration of the study.
- Allergy to macrolide derivatives.
- Exposure to UV or concomitant exposure to the sun without protective shield.
- Concomitant immunosuppressive therapy or oral corticosteroids for topical (on the vitiligo lesions) or systemic
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Bordeaux
Bordeaux, Gironde, 33 404
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-Maritimes, 06200
About this study
Official title: Maintenance Treatment of Non Segmental Vitiligo With Tacrolimus Ointment 0.1% Versus Control, Randomized and Double Blind Study
Tacrolimus ointment 0.1% has shown promising results for treating vitiligo in many prospective studies. Prospective randomized studies versus placebo are required to confirm the hypothesis that maintenance treatment with two applications of tacrolimus ointment 0.1% per week can reduce relapses of non-segmental vitiligo lesions.
Main objective To assess the efficacy of maintenance therapy with topical tacrolimus vs placebo in the prevention of depigmentation in patients with vitiligo who responded to treatment.
Read more
Secondary objectives
- Evaluate the efficacy of maintenance therapy with tacrolimus vs topical placebo to decrease the intensity of depigmentation in patients with vitiligo who responded to treatment.
- To study the occurrence of possible adverse effects.
Length of the study Inclusion: 12 months Treatment: 6 months Follow-up: 6 months Total length of the study: 18 months
Intervention Multicentric prospective interventional randomized comparative study versus placebo.
- Visit V0: Selection Information of the patient, control of inclusion and non inclusion criteria.
- Visit V1: Control of inclusion and non inclusion criteria, patients signed informed consent. An initial clinical evaluation and photographs in direct sunlight and UV. Topical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.
- Visit V2:
The patient will be reviewed after the end of treatment (24 weeks after the visit V1) for final evaluation. A clinical assessment will be made and photographs in the same way as the inclusion. Adverse reactions during treatment will be collected by the investigator (they will be noted as and when the patient in a notebook that will be presented at baseline).
The percentage of depigmentation will be evaluated in a blinded treatment of photographs by two reviewers. In case of disagreement, the opinion of a third appraiser will be required.
- End of study: After the end of the study patients will be supported via the usual care recommended for their condition.
Evaluation criteria
- primary endpoint ---Percentage of patients at 24 weeks without depigmentation (depigmentation score = 0). A score of depigmentation from 0 to 2 will be used. A blind treatment evaluation of direct light and UV photographs will be made by two independent observers (dermatologists) between inclusion and after 24 weeks of treatment.
- secondary endpoints ---- The efficiency to reduce the intensity of relapses will be evaluated using the score of depigmentation (rate of patients with a score of 0 or 1 in each group) and the VASI score (Appendix 4).
- The frequency, severity and time of occurrence of adverse events are reported. Side effects are classified into grades according to WHO criteria.
Number of subject Considering that depigmentation occurs in more than 40% of patients during the 24 weeks of maintenance treatment and hoped that the proactive treatment will reduce the rate of depigmentation of 10%, a population of 26 patients per group will be necessary (taking into account 10% of patients lost to follow). The total number of patients to be included in the study will be 52.
- Conditions
- Pigmentation Disorders, Vitiligo
- Being tested
- Protopic, Placebo : Diprobase
- Keywords
- [C17.800.621]
- Medical subject headings
- Pigmentation Disorders, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtopicDrug
Topical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.
Placebo : DiprobaseDrug
Topical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus ointment 0.1% | Experimental | Not described Receives: Drug: Protopic |
| Group Placebo | Placebo comparator | Not described Receives: Drug: Placebo : Diprobase |
What is being measured
The primary outcome is the main question the study is designed to answer.
UV and direct light photographs
Comparison of photographs between day 0 and 24 weeks by two independent-blinded dermatologists
Measured: At 6 months
Secondary outcomes (1)
Score of depigmentation, VASI score. Frequency and severity of adverse events.
Score of depigmentation, VASI score. Frequency and severity of adverse events.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmentation DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PASSERON Thierry, Pu-Ph, Principal investigator, CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841008
- Sponsor's protocol ID
- 11-PP-12
- Status last verified
- Jun 2014
- First submitted
- 23 Mar 2012
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Treatment of Non Segmental Vitiligo With Tacrolimus Ointment 0.1% Versus Control, Randomized and Double Blind Study
- ClinicalTrials.gov ID
- NCT01841008
- Acronym / sponsor ID
- 11-PP-12
- Conditions
- Pigmentation Disorders, Vitiligo
- Keywords
- [C17.800.621]
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Apr 2013 (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.
Tacrolimus ointment 0.1% has shown promising results for treating vitiligo in many prospective studies. Prospective randomized studies versus placebo are required to confirm the hypothesis that maintenance treatment with two applications of tacrolimus ointment 0.1% per week can reduce relapses of non-segmental vitiligo lesions.
Main objective To assess the efficacy of maintenance therapy with topical tacrolimus vs placebo in the prevention of depigmentation in patients with vitiligo who responded to treatment.
Secondary objectives
- Evaluate the efficacy of maintenance therapy with tacrolimus vs topical placebo to decrease the intensity of depigmentation in patients with vitiligo who responded to treatment.
- To study the occurrence of possible adverse effects.
Length of the study Inclusion: 12 months Treatment: 6 months Follow-up: 6 months Total length of the study: 18 months
Intervention Multicentric prospective interventional randomized comparative study versus placebo.
- Visit V0: Selection Information of the patient, control of inclusion and non inclusion criteria.
- Visit V1: Control of inclusion and non inclusion criteria, patients signed informed consent. An initial clinical evaluation and photographs in direct sunlight and UV. Topical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.
- Visit V2:
The patient will be reviewed after the end of treatment (24 weeks after the visit V1) for final evaluation. A clinical assessment will be made and photographs in the same way as the inclusion. Adverse reactions during treatment will be collected by the investigator (they will be noted as and when the patient in a notebook that will be presented at baseline).
The percentage of depigmentation will be evaluated in a blinded treatment of photographs by two reviewers. In case of disagreement, the opinion of a third appraiser will be required.
- End of study: After the end of the study patients will be supported via the usual care recommended for their condition.
Evaluation criteria
- primary endpoint ---Percentage of patients at 24 weeks without depigmentation (depigmentation score = 0). A score of depigmentation from 0 to 2 will be used. A blind treatment evaluation of direct light and UV photographs will be made by two independent observers (dermatologists) between inclusion and after 24 weeks of treatment.
- secondary endpoints ---- The efficiency to reduce the intensity of relapses will be evaluated using the score of depigmentation (rate of patients with a score of 0 or 1 in each group) and the VASI score (Appendix 4).
- The frequency, severity and time of occurrence of adverse events are reported. Side effects are classified into grades according to WHO criteria.
Number of subject Considering that depigmentation occurs in more than 40% of patients during the 24 weeks of maintenance treatment and hoped that the proactive treatment will reduce the rate of depigmentation of 10%, a population of 26 patients per group will be necessary (taking into account 10% of patients lost to follow). The total number of patients to be included in the study will be 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus ointment 0.1% | Experimental | Drug: Protopic |
| Group Placebo | Placebo comparator | Drug: Placebo : Diprobase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Non-segmental vitiligo repigmented more than 75% with treatment (any type of treatment is accepted: NB-UVB, PUVA, lamp or excimer laser at 308 nm, topical steroids, topical tacrolimus, graft). The total area treated plates during maintenance treatment should not exceed 10% of the total body surface area.
- Affiliation to the Social Security
- Informed consent signed by the patient
Key exclusion criteria (5 listed)
- Segmental Vitiligo
- Pregnant or breastfeeding women (pregnancy test will be conducted); effective contraception will be maintained for the duration of the study.
- Allergy to macrolide derivatives.
- Exposure to UV or concomitant exposure to the sun without protective shield.
- Concomitant immunosuppressive therapy or oral corticosteroids for topical (on the vitiligo lesions) or systemic
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 |
|---|---|---|
| ProtopicTopical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks. | Drug | Tacrolimus ointment 0.1% |
| Placebo : DiprobaseTopical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks. | Drug | Group Placebo |
Primary outcome
UV and direct light photographs
Time frame: At 6 months
Comparison of photographs between day 0 and 24 weeks by two independent-blinded dermatologists
1 secondary outcome
Score of depigmentation, VASI score. Frequency and severity of adverse events.
Time frame: At 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
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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.
PASSERON Thierry, Pu-Ph principal investigator
CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Protopic in people with Pigmentation Disorders and Vitiligo, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
UV and direct light photographs (time frame: At 6 months). 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 5 Sep 2014.