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Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo

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ClinicalTrials.gov Identifier: NCT03365141
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Jung Min Bae, The Catholic University of Korea

Brief Summary:
A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo

Condition or disease Intervention/treatment Phase
Vitiligo Treatment Intralesional Injection Corticosteroid Drug: Triamcinolone acetonide 0.4mg/cc Device: Phototherapy (NBUVB or excimer laser) Drug: Topical tacrolimus Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
Actual Study Start Date : November 14, 2017
Estimated Primary Completion Date : September 15, 2018
Estimated Study Completion Date : September 15, 2018


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.

Drug: 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

Device: Phototherapy (NBUVB or excimer laser)
NBUVB or excimer laser treatment weekly

Drug: Topical tacrolimus
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.
Device: Phototherapy (NBUVB or excimer laser)
NBUVB or excimer laser treatment weekly

Drug: Topical tacrolimus
Application of topical tacrolimus ointment twice a day




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The adverse effects [ Time Frame: every weeks up to 13 weeks ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age : 19 or older
  2. A patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study
  3. A patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk
  4. 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:

  1. Patients under the age of 19
  2. Patients with enlarged or spreading lesions of vitiligo
  3. Patients who do not want to do so or who refuse to write a consent form
  4. 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)
  5. Others those who are deemed unsuitable for the examination at the discretion of the examiner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365141


Locations
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Korea, Republic of
St. Vincent's Hospital Recruiting
Suwon, Gyonggi-do, Korea, Republic of, 16247
Contact: Jung Min Bae, MD, PhD    +82.31-249-7461    jminbae@gmail.com   
Sponsors and Collaborators
The Catholic University of Korea

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Responsible Party: Jung Min Bae, Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03365141     History of Changes
Other Study ID Numbers: VC17MESI0190
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jung Min Bae, The Catholic University of Korea:
vitiligo
intralesional injection
corticosteroid
triamcinolone

Additional relevant MeSH terms:
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Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone
Triamcinolone hexacetonide
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists