Maintenance Therapy of Narrow-band UV-B Therapy in Patients With Vitiligo

NCT03384342 | Unknown DMC

• 1 other identifier: VC17DEDI0185
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Although vitiligo is difficult to cure, recurrences are frequent after treatment, and many patients suffer from concerns about recurrence as well as disease. Psoriasis, another indication for ultraviolet radiation treatment, has been established that it can safely and effectively reduce the recurrence of psoriasis through monthly maintenance therapy. The aim of this study was to evaluate the efficacy of Narrow-band UV-B therapy for the prevention of relapse in vitiligo.

Conditions

Phototherapy; Vitiligo; Maintenance Therapy; Narrow-band UV-B

Outcome Measures

Primary Outcomes (1)

• Recurrence of vitiligo

  Clinical photographs taken before and 12 months after the completion of the study. The photographs will be used to measure the area of vitiligo lesion, and the investigators will compare the area score and judge whether or not there is a recurrence.

  change from baseline area score at 12 months

Secondary Outcomes (1)

• The assessment of patient satisfaction

  at baseline and at 12 months

Study Arms (2)

Experimental group

EXPERIMENTAL

* For a total period of 12 months, perform Narrow-band UV-B therapy treatment once a month. * At this time, the dose of Narrow-band UV-B therapy therapy is based on the 50% of the maximum dose that the patient received for the treatment.

Device: Narrow-band UV-B therapy

Control group

NO INTERVENTION

* Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months. * If recurrence of vitiligo is observed during the follow-up period, visit the clinic and check for recurrence.

Interventions

Narrow-band UV-B therapy DEVICE

* Patients treated with NBUVB and showed 75% or more repigmentation rate would be included. * For a total period of 12 months, narrow-band UV-B therapy is performed once a month.

Experimental group

Eligibility Criteria

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

You may qualify if:

• Patients with age of 19 years or older
• Patients of generalized vitiligo with lesions on the trunk
• Patients who had treated with Narrow-band UV-B therapy previously and achieved more than 75% lesion improvement
• Patients who voluntarily agreed to participate in the study

You may not qualify if:

• Patients under the age of 19
• Patients with localized vitiligo and segmental vitiligo
• Patients who are in a state of physical or mental impairment to perform treatment or pregnant
• Patients with spreading of vitiligo lesions
• Patients who do not want to do thie study or who refuse to write a consent form
• Any other person 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

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jung Min Bae, MD, PhD

CONTACT

82-31-249-7460; jminbae@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 27, 2017
• Study Start: November 18, 2017
• Primary Completion: November 18, 2018
• Study Completion: May 18, 2019
• Last Updated: December 27, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)