Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo

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

Study Overview

• Status: Unknown
• Conditions: Vitiligo; Treatment; Corticosteroid; Intralesional Injection
• Intervention / Treatment: Drug: Triamcinolone acetonide 0.4mg/cc; Device: Phototherapy (NBUVB or excimer laser); Drug: Topical tacrolimus

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: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyonggi-do
    • Suwon, Gyonggi-do, Korea, Republic of, 16247
      • Recruiting
      • St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The adverse effects	every weeks up to 13 weeks

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2017
• Primary Completion (Anticipated): September 15, 2018
• Study Completion (Anticipated): September 15, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: triamcinolone; corticosteroid; vitiligo; intralesional injection
• 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)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No