- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03365141
Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyonggi-do
-
Suwon, Gyonggi-do, Korea, Republic of, 16247
- Recruiting
- St. Vincent's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
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. |
NBUVB or excimer laser treatment weekly
Application of topical tacrolimus ointment twice a day
|
Active Comparator: Control group
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.
|
NBUVB or excimer laser treatment weekly
Application of topical tacrolimus ointment twice a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The adverse effects
Time Frame: every weeks up to 13 weeks
|
every weeks up to 13 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Pigmentation Disorders
- Hypopigmentation
- Vitiligo
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Calcineurin Inhibitors
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
- Tacrolimus
Other Study ID Numbers
- VC17MESI0190
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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