Dermatologic DiseaseNCT03047733
Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo
A study testing The XTRAC Excimer Laser System and Topical tacrolimus 0.1% ointment in people with Dermatologic Disease and Vitiligo, run by Ajou University School of Medicine at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Dermatologic Disease, Vitiligo
- What is being tested?
- The XTRAC Excimer Laser System and Topical tacrolimus 0.1% ointment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jul 2015to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with symmetric vitiligo
- Patients with less than 5 years' disease duration
Who cannot join
- The patients taking systemic steroids
- The patients with currently enlarging lesions
- The patients who cannot follow the treatment schedule
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo: A Randomized Controlled Non-inferiority Trial
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.
Read more
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.
Read the 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.
- Conditions
- Dermatologic Disease, Vitiligo
- Being tested
- The XTRAC Excimer Laser System, Topical tacrolimus 0.1% ointment
- Keywords
- Vitiligo, 308 nm excimer laser
- Medical subject headings
- Skin Diseases, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The XTRAC Excimer Laser SystemDevice
Also called XTRAC Velocity 400
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.
Topical tacrolimus 0.1% ointmentDrug
Application of topical tacrolimus 0.1% ointment on the both lesions once daily.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: The XTRAC Excimer Laser System; Drug: Topical tacrolimus 0.1% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start21 Jul 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dermatologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Min Sung, Ajou University School of Medicine
- Investigators
- HEE YOUNG KANG, M.D., Ph.D., Study director, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047733
- Sponsor's protocol ID
- AJIRB-MED-DE3-15-151
- Status last verified
- Feb 2017
- First submitted
- 5 Feb 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 20584252Hofer 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.
PubMed 15888156Park 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.
PubMed 22524428Aberdam 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.
PubMed 7907336
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo: A Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT03047733
- Acronym / sponsor ID
- AJIRB-MED-DE3-15-151
- Conditions
- Dermatologic Disease, Vitiligo
- Keywords
- Vitiligo, 308 nm excimer laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| continuously excimer laser treatment | Active comparator | Device: The XTRAC Excimer Laser System, Drug: Topical tacrolimus 0.1% ointmentIn 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). |
| cyclic excimer laser treatment | Experimental | Device: The XTRAC Excimer Laser System, Drug: Topical tacrolimus 0.1% ointmentIn 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). |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with symmetric vitiligo
- Patients with less than 5 years' disease duration
Key exclusion criteria (3 listed)
- The patients taking systemic steroids
- The patients with currently enlarging lesions
- The patients who cannot follow the treatment schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The XTRAC Excimer Laser SystemAlso: XTRAC Velocity 400Initial 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. | Device | continuously excimer laser treatment, cyclic excimer laser treatment |
| Topical tacrolimus 0.1% ointmentApplication of topical tacrolimus 0.1% ointment on the both lesions once daily. | Drug | continuously excimer laser treatment, cyclic excimer laser treatment |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Background: PubMed 20584252Zhang 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.
- Background: PubMed 15888156Hofer 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.
- Background: PubMed 22524428Park 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.
- Results publication: PubMed 7907336Aberdam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HEE YOUNG KANG, M.D., Ph.D. study director
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The XTRAC Excimer Laser System and Topical tacrolimus 0.1% ointment in people with Dermatologic Disease and Vitiligo, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047733, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.