Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo

NCT03047733 | Completed FDA Device

• 1 other identifier: AJIRB-MED-DE3-15-151
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVE: To investigate the efficacy of the cyclic on-off treatment compared to the conventional continuous excimer laser treatment. DESIGN: A randomized, controlled, split-body, non-inferiority study. SETTING: The trial was performed in two tertiary health care centers in Korea. PARTICIPANT: Twelve patients (16 pairs of lesions) with stable symmetric vitiligo less than 5 years' disease duration were enrolled. INTERVENSION: The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic on-off treatment. All lesions were treated twice weekly for 9-month: continuously, or cyclically with 2-month treatment and 1-month intermission (total 3 cycles). Topical tacrolimus was applied throughout the trial. OUTCOME MEASURES: The repigmentation was assessed using an image analysis program with clinical photographs. The primary outcome was mean difference of repigmentation rates and the non-inferiority margin was set at 10%. During intermission period, the clinical changes such as loss of repigmentation or worsening of the vitiligo lesions were assessed.

Conditions

Dermatologic Disease; Vitiligo

Keywords

Vitiligo; 308 nm excimer laser

Outcome Measures

Primary Outcomes (1)

• Mean difference of quantitative changes in repigmented area between continuous and cyclic on-off treatment.

  The degree of repigmentation was assessed with a repigmentation rate (%) with clinical photographs by using an image analysis program (Digital Researcher for Vitiligo Area Evaluation, Dr. VAE, Korea).

  Through study completion, an average of 9 months

Study Arms (2)

continuously excimer laser treatment

ACTIVE COMPARATOR

In this group, lesions treated twice weekly through out the whole trial length (9 months). Application of topical tacrolimus 0.1% ointment through out the whole trial length (9 months).

Device: The XTRAC Excimer Laser System; Drug: Topical tacrolimus 0.1% ointment

cyclic excimer laser treatment

EXPERIMENTAL

In this group, one cycle consists of a 2-month treatment period (on) and a consecutive 1-month intermission period (off). Total 3 cycles of cyclic treatment through out the whole trial length (9 months). During the treatment period, lesions treated twice weekly. Application of topical tacrolimus 0.1% ointment through out the whole trial length (9 months).

Device: The XTRAC Excimer Laser System; Drug: Topical tacrolimus 0.1% ointment

Interventions

The XTRAC Excimer Laser System DEVICE

Initial irradiation dose was 50 mJ/cm2 on face and 100 mJ/cm2 on trunk and extremities. If there had not been minimal asymptomatic erythema, energy level was escalated by 50 mJ/cm2.

Also known as: XTRAC Velocity 400

continuously excimer laser treatment; cyclic excimer laser treatment

Topical tacrolimus 0.1% ointment DRUG

Application of topical tacrolimus 0.1% ointment on the both lesions once daily.

continuously excimer laser treatment; cyclic excimer laser treatment

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symmetric vitiligo
• Patients with less than 5 years' disease duration

You may not qualify if:

• The patients taking systemic steroids
• The patients with currently enlarging lesions
• The patients who cannot follow the treatment schedule

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou university hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Related Publications (4)

• Zhang XY, He YL, Dong J, Xu JZ, Wang J. Clinical efficacy of a 308 nm excimer laser in the treatment of vitiligo. Photodermatol Photoimmunol Photomed. 2010 Jun;26(3):138-42. doi: 10.1111/j.1600-0781.2010.00509.x.

  PMID: 20584252 BACKGROUND

• Hofer A, Hassan AS, Legat FJ, Kerl H, Wolf P. Optimal weekly frequency of 308-nm excimer laser treatment in vitiligo patients. Br J Dermatol. 2005 May;152(5):981-5. doi: 10.1111/j.1365-2133.2004.06321.x.

  PMID: 15888156 BACKGROUND

• Park KK, Liao W, Murase JE. A review of monochromatic excimer light in vitiligo. Br J Dermatol. 2012 Sep;167(3):468-78. doi: 10.1111/j.1365-2133.2012.11008.x. Epub 2012 Aug 8.

  PMID: 22524428 BACKGROUND

• Aberdam E, Romero C, Ortonne JP. Repeated UVB irradiations do not have the same potential to promote stimulation of melanogenesis in cultured normal human melanocytes. J Cell Sci. 1993 Dec;106 ( Pt 4):1015-22. doi: 10.1242/jcs.106.4.1015.

  PMID: 7907336 RESULT

MeSH Terms

Conditions

Skin Diseases; Vitiligo

Interventions

Tacrolimus; Ointments

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Hypopigmentation; Pigmentation Disorders

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• HEE YOUNG KANG, M.D., Ph.D.

  Ajou University School of Medicine

  STUDY DIRECTOR

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: Resident of the department of dermatology

Model Details: A randomized, controlled, split-body, non-inferiority trial. Patients with stable symmetric vitiligo were enrolled. The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic on-off excimer laser treatment. Total duration of study was 9 months. In cyclic on-off excimer laser treatment, the cycle was arbitrarily determined that one cycle consists of a 2-month treatment period (on) and a consecutive 1-month intermission period (off).

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 9, 2017
• Study Start: July 21, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)