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

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ClinicalTrials.gov Identifier: NCT03047733
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Jae Min Sung, Ajou University School of Medicine

Tracking Information
First Submitted Date  ICMJE February 5, 2017
First Posted Date  ICMJE February 10, 2017
Last Update Posted Date February 10, 2017
Actual Study Start Date  ICMJE July 21, 2015
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
Mean difference of quantitative changes in repigmented area between continuous and cyclic on-off treatment. [ Time Frame: Through study completion, an average of 9 months ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo
Official Title  ICMJE Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo: A Randomized Controlled Non-inferiority Trial
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.

Detailed Description

[Study design and population] A randomized, controlled, split-body, non-inferiority trial was designed.

After obtaining informed consent, 12 patients with stable symmetric vitiligo less than 5 years' disease duration were enrolled.

The patients taking systemic steroids or having enlarging lesions were excluded. The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic excimer laser treatment.

Total duration of study was 9 months.

In cyclic 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) (total 3 cycles during the trial).

[Treatment protocol]

The lesions were treated twice a week. 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. In cyclic treatment, the treatment resumed after intermission with the previously used irradiation dose.

Topical tacrolimus 0.1% ointment was applied in both twice daily throughout whole length of the trial.

[Assessment and primary outcome] Photographic documentation of lesions was conducted every month and the degree of repigmentation was assessed with a repigmentation rate (%) from the baseline by using an image analysis program (Digital Researcher for Vitiligo Area Evaluation, Dr. VAE, Korea).

An intention-to-treat analysis was planned, and last observation carried forward method was applied to impute the missing value in the presence of dropouts.

The primary outcome was mean difference of quantitative changes in repigmented area between continuous and cyclic on-off treatment. The non-inferiority margin was set at 10%. During intermission period in the cyclic treatment, the clinical changes such as loss of repigmentation or worsening of the vitiligo lesions were assessed.

[Statistical analysis] All statistical analyses were conducted using R 3.2.4 (R Foundation for Statistical Computing, Austria) and a P value <0.05 was considered statistically significant.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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).

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dermatologic Disease
  • Vitiligo
Intervention  ICMJE
  • Device: The XTRAC Excimer Laser System
    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.
    Other Name: XTRAC Velocity 400
  • Drug: Topical tacrolimus 0.1% ointment
    Application of topical tacrolimus 0.1% ointment on the both lesions once daily.
Study Arms  ICMJE
  • Active Comparator: continuously excimer laser treatment

    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).

    Interventions:
    • Device: The XTRAC Excimer Laser System
    • Drug: Topical tacrolimus 0.1% ointment
  • Experimental: cyclic excimer laser treatment

    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).

    Interventions:
    • Device: The XTRAC Excimer Laser System
    • Drug: Topical tacrolimus 0.1% ointment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2017)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • The patients taking systemic steroids
  • The patients with currently enlarging lesions
  • The patients who cannot follow the treatment schedule
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03047733
Other Study ID Numbers  ICMJE AJIRB-MED-DE3-15-151
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jae Min Sung, Ajou University School of Medicine
Study Sponsor  ICMJE Ajou University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: HEE YOUNG KANG, M.D., Ph.D. Ajou University School of Medicine
PRS Account Ajou University School of Medicine
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP