Back to resultsEfficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
Primary Purpose
Vitiligo, Treatment, Intralesional Injection
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Triamcinolone acetonide 0.4mg/cc
Phototherapy (NBUVB or excimer laser)
Topical tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring vitiligo, intralesional injection, corticosteroid, triamcinolone
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- St. Vincent's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The adverse effects
Full Information
NCT ID
NCT03365141
First Posted
November 30, 2017
Last Updated
December 5, 2017
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT03365141
Brief Title
Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
Official Title
Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
September 15, 2018 (Anticipated)
Study Completion Date
September 15, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo, Treatment, Intralesional Injection, Corticosteroid
Keywords
vitiligo, intralesional injection, corticosteroid, triamcinolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Triamcinolone acetonide 0.4mg/cc
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Phototherapy (NBUVB or excimer laser)
Intervention Description
NBUVB or excimer laser treatment weekly
Intervention Type
Drug
Intervention Name(s)
Topical tacrolimus
Intervention Description
Application of topical tacrolimus ointment twice a day
Primary Outcome Measure Information:
Title
The repigmentation rate (change from baseline) of the vitiliginous patch
Description
The degree of repigmentation will be assessed as % from baseline by using a computer program.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
The adverse effects
Time Frame
every weeks up to 13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
St. Vincent's Hospital
City
Suwon
State/Province
Gyonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Min Bae, MD, PhD
Phone
+82.31-249-7461
Email
jminbae@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
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