VitiligoNCT03365141
Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
A study testing Triamcinolone acetonide 0.4mg/cc, Phototherapy (NBUVB or excimer laser) and Topical tacrolimus in people with Vitiligo and Treatment, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Vitiligo, Treatment, Intralesional Injection
- What is being tested?
- Triamcinolone acetonide 0.4mg/cc, Phototherapy (NBUVB or excimer laser) and Topical tacrolimus
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Nov 2017to 15 Sep 2018
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age : 19 or older
- A patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study
- A patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk
- A patient who has no further response to excimer laser or short wavelength ultraviolet B therapy, which is a conventional treatment for vitiligo
Who cannot join
- Patients under the age of 19
- Patients with enlarged or spreading lesions of vitiligo
- Patients who do not want to do so or who refuse to write a consent form
- Patients who are inadequate for triamcinolone acetonide administration (pregnant women, infectious and systemic fungal infections without effective antimicrobial agents, immunosuppression, hypersensitivity reactions to and concomitant use of triamcinolone or its components, spontaneous thrombocytopenia, purpura, herpes simplex, shingles, chicken pox patients)
- Others those who are deemed unsuitable for the examination at the discretion of the examiner
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
St. Vincent's Hospital
Suwon, Gyonggi-do, 16247
Jung Min Bae, MD, PhD, +82.31-249-7461, jminbae@gmail.com
About this study
A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo
Read the detailed description
Intralesional corticosteroid injections have been a long-standing treatment for refractory vitiligo, with some patients showing significant improvement without surgical intervention.
The investigators will perform a randomized split-body pilot trial to test the exact efficacy of intralesional triamcinolone injections. The paired symmetric vitiliginous lesions will be randomized to either control or injection groups. All lesions will be treated with narrowband UV-B phototerapy or excimer laser weekly and twice daily application of topical tacrolimus ointment for a total of 12-week period. Intralesional injections of 0.4mg/cc triamcinolone once a week are given to the experimental group. The degree of repigmentation will be assessed as % from baseline.
- Conditions
- Vitiligo, Treatment, Intralesional Injection, Corticosteroid
- Being tested
- Triamcinolone acetonide 0.4mg/cc, Phototherapy (NBUVB or excimer laser), Topical tacrolimus
- Keywords
- vitiligo, intralesional injection, corticosteroid, triamcinolone
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonide 0.4mg/ccDrug
- Intralesional injection of dilute triamcinolone acetonide with 2% lidocaine (400mg/20 mL) would be performed to reduce pain when injecting the drug.
- Once weekly, for a total of 12 weeks
Phototherapy (NBUVB or excimer laser)Device
NBUVB or excimer laser treatment weekly
Topical tacrolimusDrug
Application of topical tacrolimus ointment twice a day
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period.
Intervention: Intralesional injection of triamcinolone acetonide (0.4mg/cc) will be performed weekly. Receives: Drug: Triamcinolone acetonide 0.4mg/cc; Device: Phototherapy (NBUVB or excimer laser); Drug: Topical tacrolimus |
| Control group | Active comparator | All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period. Receives: Device: Phototherapy (NBUVB or excimer laser); Drug: Topical tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The repigmentation rate (change from baseline) of the vitiliginous patch
The degree of repigmentation will be assessed as % from baseline by using a computer program.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
The adverse effects
Measured: every weeks up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start14 Nov 2017
- Primary completion15 Sep 2018 (estimated)
- Study completion15 Sep 2018 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Min Bae, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365141
- Sponsor's protocol ID
- VC17MESI0190
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT03365141
- Acronym / sponsor ID
- VC17MESI0190
- Conditions
- Vitiligo, Treatment, Intralesional Injection, Corticosteroid
- Keywords
- vitiligo, intralesional injection, corticosteroid, triamcinolone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 15 Sep 2018 (estimated)
- Study completion
- 15 Sep 2018 (estimated)
- First posted
- 7 Dec 2017 (actual)
- 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.
A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo
Detailed description
Intralesional corticosteroid injections have been a long-standing treatment for refractory vitiligo, with some patients showing significant improvement without surgical intervention.
The investigators will perform a randomized split-body pilot trial to test the exact efficacy of intralesional triamcinolone injections. The paired symmetric vitiliginous lesions will be randomized to either control or injection groups. All lesions will be treated with narrowband UV-B phototerapy or excimer laser weekly and twice daily application of topical tacrolimus ointment for a total of 12-week period. Intralesional injections of 0.4mg/cc triamcinolone once a week are given to the experimental group. The degree of repigmentation will be assessed as % from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Triamcinolone acetonide 0.4mg/cc, Device: Phototherapy (NBUVB or excimer laser), Drug: Topical tacrolimusAll lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period. Intervention: Intralesional injection of triamcinolone acetonide (0.4mg/cc) will be performed weekly. |
| Control group | Active comparator | Device: Phototherapy (NBUVB or excimer laser), Drug: Topical tacrolimusAll lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age : 19 or older
- A patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study
- A patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk
- A patient who has no further response to excimer laser or short wavelength ultraviolet B therapy, which is a conventional treatment for vitiligo
Key exclusion criteria (5 listed)
- Patients under the age of 19
- Patients with enlarged or spreading lesions of vitiligo
- Patients who do not want to do so or who refuse to write a consent form
- Patients who are inadequate for triamcinolone acetonide administration (pregnant women, infectious and systemic fungal infections without effective antimicrobial agents, immunosuppression, hypersensitivity reactions to and concomitant use of triamcinolone or its components, spontaneous thrombocytopenia, purpura, herpes simplex, shingles, chicken pox patients)
- Others those who are deemed unsuitable for the examination at the discretion of the examiner
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 |
|---|---|---|
| Triamcinolone acetonide 0.4mg/cc* Intralesional injection of dilute triamcinolone acetonide with 2% lidocaine (400mg/20 mL) would be performed to reduce pain when injecting the drug. * Once weekly, for a total of 12 weeks | Drug | Experimental group |
| Phototherapy (NBUVB or excimer laser)NBUVB or excimer laser treatment weekly | Device | Control group, Experimental group |
| Topical tacrolimusApplication of topical tacrolimus ointment twice a day | Drug | Control group, Experimental group |
Primary outcome
The repigmentation rate (change from baseline) of the vitiliginous patch
Time frame: Baseline and 12 weeks
The degree of repigmentation will be assessed as % from baseline by using a computer program.
1 secondary outcome
The adverse effects
Time frame: every weeks up to 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone acetonide 0.4mg/cc, Phototherapy (NBUVB or excimer laser) and Topical tacrolimus in people with Vitiligo and Treatment, run by The Catholic University of Korea at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 7 Dec 2017. 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 South Korea. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The repigmentation rate (change from baseline) of the vitiliginous patch (time frame: Baseline and 12 weeks). 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 7 Dec 2017.