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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03365141
Other study ID # VC17MESI0190
Secondary ID
Status Recruiting
Phase N/A
First received November 30, 2017
Last updated December 5, 2017
Start date November 14, 2017
Est. completion date September 15, 2018

Study information

Verified date December 2017
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date September 15, 2018
Est. primary completion date September 15, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of St. Vincent's Hospital Suwon Gyonggi-do

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The adverse effects every weeks up to 13 weeks
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