Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03047733
Other study ID # AJIRB-MED-DE3-15-151
Secondary ID
Status Completed
Phase N/A
First received February 5, 2017
Last updated February 7, 2017
Start date July 21, 2015
Est. completion date December 31, 2016

Study information

Verified date February 2017
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 10 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Ajou university hospital Suwon-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Aberdam E, Roméro 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT05298033 - Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo Phase 2
Recruiting NCT05872477 - Promoting Repigmentation After Epidermal Cell Suspension Grafting and preVENTing the Loss of Melanocytes Using Topical Ruxolitinib for Vitiligo in Resistant Areas Phase 2
Terminated NCT04374435 - Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo N/A
Completed NCT04103060 - Safety and Tolerability Study of Cerdulatinib Gel, 0.37% in Adults With Vitiligo Phase 2
Terminated NCT04271501 - Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure for Repigmentation of Stable Vitiligo Lesions N/A
Completed NCT04530344 - Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo Phase 3
Not yet recruiting NCT05008887 - Fractional CO2 Laser-assisted Cutaneous Delivery of Methotrexate Versus 5-fluorouracil in Stable Non-segmental Vitiligo Phase 4
Terminated NCT02191748 - Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo Phase 2/Phase 3
Completed NCT01382589 - Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo Phase 2
Terminated NCT01262547 - A New Micrografting Technique for Vitiligo Phase 2
Active, not recruiting NCT04971200 - Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo Early Phase 1
Completed NCT04872257 - Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo N/A
Completed NCT04547998 - Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions N/A
Not yet recruiting NCT04039451 - Prevalence of Psoriasis and Vitiligo in Assiut Governorate, Egypt
Not yet recruiting NCT03611348 - Microneedling and Latanoprost in Acrofacial Vitiligo Phase 2/Phase 3
Recruiting NCT03199664 - Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo Phase 4
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Completed NCT03249064 - Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo N/A
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2