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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Dermatologic Disease Vitiligo Device: The XTRAC Excimer Laser System Drug: Topical tacrolimus 0.1% ointment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Official Title: Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo: A Randomized Controlled Non-inferiority Trial
Actual Study Start Date : July 21, 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo
Drug Information available for: Tacrolimus

Arm Intervention/treatment
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).

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.

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).

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.




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047733


Locations
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Korea, Republic of
Ajou university hospital
Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Study Director: HEE YOUNG KANG, M.D., Ph.D. Ajou University School of Medicine
Publications of Results:
Other Publications:
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Responsible Party: Jae Min Sung, Resident of the department of dermatology, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03047733    
Other Study ID Numbers: AJIRB-MED-DE3-15-151
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Jae Min Sung, Ajou University School of Medicine:
Vitiligo
308 nm excimer laser
Additional relevant MeSH terms:
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Vitiligo
Skin Diseases
Hypopigmentation
Pigmentation Disorders
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action