VitiligoPhase 4NCT01333410
Comparison of Efficacy and Safety of 0.1% Tacrolimus and 0.1% Mometasone Furoate for Adult Vitiligo
A Phase 4 study testing tacrolimus ointment and Mometasone furoate in people with Vitiligo, run by Mahidol University at 1 site in Thailand.
Trial summary
Vitiligo has remained a difficult disease to treat. Previous available therapies are often ineffective. It usually takes several months or years for complete repigmentation and some areas of the body get at best only partial repigmentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- tacrolimus ointment and Mometasone furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2009to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be above 18 years old
- Patients must have symmetrical vitiligo lesion on both sides of the body. Total vitiligo area is not exceeded 5% of the body surface area
- Discontinue any previous systemic medication or phototherapy for at least 3 months and discontinue any topical medication for at least 1 month before starting the study
Who cannot join
- Patient who have the lesion on acral area (hands or feet)
- Pregnancy or lactation patient
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Dermatology, Faculty of Medicine Siriraj Hospital
Bangkok
About this study
Official title: Comparison the Efficacy and Safety of 0.1% Tacrolimus Ointment With 0.1% Mometasone Furoate Cream in the Treatment of Adult Vitiligo: A Single Blinded Pilot Study
Vitiligo has remained a difficult disease to treat. Previous available therapies are often ineffective. It usually takes several months or years for complete repigmentation and some areas of the body get at best only partial repigmentation. The desire of the patient to undergo therapy varies from patient to patient and needs to be assessed individually. Several factors should be considered when planning the treatment strategies including type of vitiligo, site and degree of involvement, skin color, psychological effect, patient compliance, ease to assess to therapy, cost of treatment and social association of the disease.
Topical corticosteroids are still be the standard treatment of localized vitiligo. However, the adverse effects such as skin atrophy, striae, pigmentary change and hypothalamic-pituitary adrenal axis suppression can occur if we use inappropriate strength of topical steroids for a long period of time.
Read more
Tacrolimus (FK-506) is a new immunosuppressive agent that acts by inhibiting T-cell activation and cytokine release. It offers a safe and efficacious alternative for many skin conditions. It minimizes the need for topical glucocorticoids and does not cause skin atrophy. Tacrolimus was first reported for treatment of vitiligo in 2002. The underlying mechanism was shown in an in vitro study that topical tacrolimus promoted proliferation of melanocytes and melanoblasts.
This study purpose is to evaluate the efficacy and safety of 0.1% topical tacrolimus ointment comparing to 0.1% mometasone furoate cream in the treatment of adult vitiligo.
Read the detailed description
At first visit, patients will be randomized to receive 0.1% tacrolimus ointment for apply to vitiligo lesion on one side of the body. The lesion on the other side of the body will be treated with 0.1% mometasone furoate cream. Patients are instructed to apply 0.1% tacrolimus ointment and 0.1% mometasone furoate cream twice a day for 6 months
Patients will be follow up at 2, 4 and 6 months for clinical improvement, side effects and photographs
- Conditions
- Vitiligo
- Being tested
- tacrolimus ointment, Mometasone furoate
- Keywords
- vitiligo, tacrolimus, mometasone furoate
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimus ointmentDrug
Also called protopic
2 applications per days for 6 months
Mometasone furoateDrug
Also called elomet
2 applications per day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 0.1% tacrolimus ointment | Active comparator | Not described Receives: Drug: tacrolimus ointment |
| 0.1% mometasone furoate cream | Active comparator | Not described Receives: Drug: Mometasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of repigmentation
Percent of patients who get repigmentation of the lesion after 0.1% tacrolimus ointment VS 0.1% mometasone furoate cream Percent of repigmentation is defined as following
- No improvement (0 % repigmentation)
- Improved by 1-25% repigmentation
- Improved by 26-50% repigmentation
- Improved by 51-75% repigmentation
- Improved by 76-100% repigmentation
Measured: 6 months
Secondary outcomes (1)
side effect
Possible side effect from topical 0.1% tacrolimus ointment and 0.1% mometasone furoate cream
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startJun 2009
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (estimated)
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 Mahidol UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, chanisada tuchinda, Mahidol University
- Investigators
- Chanisada Wongpraparut, M.D., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333410
- Sponsor's protocol ID
- MahidolU
- Status last verified
- Oct 2012
- First submitted
- 8 Apr 2011
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Efficacy and Safety of 0.1% Tacrolimus Ointment With 0.1% Mometasone Furoate Cream in the Treatment of Adult Vitiligo: A Single Blinded Pilot Study
- ClinicalTrials.gov ID
- NCT01333410
- Acronym / sponsor ID
- MahidolU
- Conditions
- Vitiligo
- Keywords
- vitiligo, tacrolimus, mometasone furoate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Apr 2011 (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.
Vitiligo has remained a difficult disease to treat. Previous available therapies are often ineffective. It usually takes several months or years for complete repigmentation and some areas of the body get at best only partial repigmentation. The desire of the patient to undergo therapy varies from patient to patient and needs to be assessed individually. Several factors should be considered when planning the treatment strategies including type of vitiligo, site and degree of involvement, skin color, psychological effect, patient compliance, ease to assess to therapy, cost of treatment and social association of the disease.
Topical corticosteroids are still be the standard treatment of localized vitiligo. However, the adverse effects such as skin atrophy, striae, pigmentary change and hypothalamic-pituitary adrenal axis suppression can occur if we use inappropriate strength of topical steroids for a long period of time.
Tacrolimus (FK-506) is a new immunosuppressive agent that acts by inhibiting T-cell activation and cytokine release. It offers a safe and efficacious alternative for many skin conditions. It minimizes the need for topical glucocorticoids and does not cause skin atrophy. Tacrolimus was first reported for treatment of vitiligo in 2002. The underlying mechanism was shown in an in vitro study that topical tacrolimus promoted proliferation of melanocytes and melanoblasts.
This study purpose is to evaluate the efficacy and safety of 0.1% topical tacrolimus ointment comparing to 0.1% mometasone furoate cream in the treatment of adult vitiligo.
Detailed description
At first visit, patients will be randomized to receive 0.1% tacrolimus ointment for apply to vitiligo lesion on one side of the body. The lesion on the other side of the body will be treated with 0.1% mometasone furoate cream. Patients are instructed to apply 0.1% tacrolimus ointment and 0.1% mometasone furoate cream twice a day for 6 months
Patients will be follow up at 2, 4 and 6 months for clinical improvement, side effects and photographs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.1% tacrolimus ointment | Active comparator | Drug: tacrolimus ointment |
| 0.1% mometasone furoate cream | Active comparator | Drug: Mometasone furoate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be above 18 years old
- Patients must have symmetrical vitiligo lesion on both sides of the body. Total vitiligo area is not exceeded 5% of the body surface area
- Discontinue any previous systemic medication or phototherapy for at least 3 months and discontinue any topical medication for at least 1 month before starting the study
Key exclusion criteria (2 listed)
- Patient who have the lesion on acral area (hands or feet)
- Pregnancy or lactation patient
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 |
|---|---|---|
| tacrolimus ointmentAlso: protopic2 applications per days for 6 months | Drug | 0.1% tacrolimus ointment |
| Mometasone furoateAlso: elomet2 applications per day for 6 months | Drug | 0.1% mometasone furoate cream |
Primary outcome
percent of repigmentation
Time frame: 6 months
Percent of patients who get repigmentation of the lesion after 0.1% tacrolimus ointment VS 0.1% mometasone furoate cream Percent of repigmentation is defined as following * No improvement (0 % repigmentation) * Improved by 1-25% repigmentation * Improved by 26-50% repigmentation * Improved by 51-75% repigmentation * Improved by 76-100% repigmentation
1 secondary outcome
side effect
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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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.
Chanisada Wongpraparut, M.D. principal investigator
Siriraj Hospital
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 tacrolimus ointment and Mometasone furoate in people with Vitiligo, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Oct 2012. 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 Thailand. 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. 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?
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?
percent of repigmentation (time frame: 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 10 Oct 2012.