Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo

NCT03365141 | Unknown DMC

• 1 other identifier: VC17MESI0190
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitiligo; Treatment; Intralesional Injection; Corticosteroid

Keywords

vitiligo; intralesional injection; corticosteroid; triamcinolone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The adverse effects

  every weeks up to 13 weeks

Study Arms (2)

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.

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.

Device: Phototherapy (NBUVB or excimer laser); Drug: Topical tacrolimus

Interventions

Triamcinolone acetonide 0.4mg/cc DRUG

* 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

Experimental group

Phototherapy (NBUVB or excimer laser) DEVICE

NBUVB or excimer laser treatment weekly

Control group; Experimental group

Topical tacrolimus DRUG

Application of topical tacrolimus ointment twice a day

Control group; Experimental group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

St. Vincent's Hospital

Suwon, Gyonggi-do, 16247, South Korea

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

Triamcinolone Acetonide; Phototherapy; Lasers, Excimer; Tacrolimus

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Therapeutics; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 7, 2017
• Study Start: November 14, 2017
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: December 7, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)