Lupus Erythematosus, DiscoidPhase 2/3NCT03178188
Efficacy of 595 nm Pulsed-dye Laser in Treatment of Discoid Lupus Erythematosus
A Phase 2/3 study testing Pulsed-dye Laser in people with Lupus Erythematosus, Discoid, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
forty DLE lesions from patients will be recruited in the study. The lesions on one side of the body were block-randomized into the treatment group and the other side served as a control. The patients can continue their systemic treatments and the PDL is designed to be used as an adjunctive treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lupus Erythematosus, Discoid
- What is being tested?
- Pulsed-dye Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 15 Dec 2016to 14 Dec 2017
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Has at least two DLE lesions, located in the same anatomical location of the body, which the different of mCLASI are not more than 1 point
- Dose not undergo any procedure or laser treatment within 4 weeks before entered the study
- Dose not received any localised therapy of DLE eg. topical corticosteriod/immunomodulator within 4 weeks before entered the study
- Dose not receive the topical chemical peeling within 4 weeks before entered the study
- Has already received at least 1 systemic standard treatment for DLE and continue until the rest of the study
- Can follow the study's protocol
Who cannot join
- Pregnancy or lactation
- History of skin cancer
- History of photo allergy
- History of bleeding tendency
- History of abnormal wound healing
Trial locations and contacts
1 site in 1 country.
Pawinee Rerknimitr, MD contact
Thailand1 site, 1 recruiting
- Recruiting
Division of Dermatology, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
Pawinee Rerknimitr, MD, MSc, +6622564253, pawineererk@yahoo.co.th
About this study
Official title: Efficacy of 595 nm Pulsed-dye Laser as an Adjunctive Treatment of Discoid Lupus Erythematosus, A Randomized, Patient/Assessor Blinded Placebo Control Trial
forty DLE lesions from patients will be recruited in the study. The lesions on one side of the body were block-randomized into the treatment group and the other side served as a control. The patients can continue their systemic treatments and the PDL is designed to be used as an adjunctive treatment. Treatments with the PDL will be delivered in the treatment group every 4 weeks for 4 consecutive months while the lesions in the control group received a sham. The patients will be evaluated at baseline (week 0), week 4, 8, 12, and at follow-up period of 4, 12 weeks after the final treatment (week 16, 24). Erythema index (EI), Texture index (TI) will be obtained and digital photographs will be taken and modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) will be assessed in every visit. The digital photographs will later be evaluated by 3-blinded dermatologists. Moreover, side effects and patients' satisfaction score will also be recorded.
- Conditions
- Lupus Erythematosus, Discoid
- Being tested
- Pulsed-dye Laser, Sham
- Keywords
- lupus erythematosus, Discoid, Pulsed-dye Laser
- Medical subject headings
- Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed-dye LaserDevice
595 nm Pulsed-dye Laser; 7mm spot sizes, 6msec pulse durations, 8j/cm2 fluences, dynamic cooling device 30/20, 4 sessions with 4 weeks interval
ShamDevice
Cryogen spray with the setting of dynamic cooling device 30/20
| Study group | Role | What they receive |
|---|---|---|
| laser treated DLE lesions | Experimental | DLE which received the pulsed-dye laser Receives: Device: Pulsed-dye Laser |
| sham treated DLE lesions | Sham comparator | DLE which received the sham Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
erythema index (EI)
Comparing changes of EI from baseline between treated group and controlled group, measured by Antera 3D camera
Measured: week 0(baseline), 4, 8, 12, 16, 24
Secondary outcomes (3)
modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI)
Comparing changes of mCLASI from baseline between treated group and controlled group, measured by 1-blinded dermatologist
Measured: week 0, 4, 8, 12, 16, 24
Physician Global Assessment (PGA) scores
Comparing overall improvement changes from baseline (PGA scores) measured by 3-blinded dermatologist
Measured: week 0, 4, 8, 12, 16, 24
texture index (TI)
Comparing changes of TI from baseline between treated group and controlled group, measured by Antera 3D camera
Measured: week 0, 4, 8, 12, 16, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start15 Dec 2016
- Primary completion14 Dec 2017 (estimated)
- Study completion14 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, DiscoidStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawinee Rerknimitr, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178188
- Sponsor's protocol ID
- 1/59
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 595 nm Pulsed-dye Laser as an Adjunctive Treatment of Discoid Lupus Erythematosus, A Randomized, Patient/Assessor Blinded Placebo Control Trial
- ClinicalTrials.gov ID
- NCT03178188
- Acronym / sponsor ID
- 1/59
- Conditions
- Lupus Erythematosus, Discoid
- Keywords
- lupus erythematosus, Discoid, Pulsed-dye Laser
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 14 Dec 2017 (estimated)
- Study completion
- 14 Dec 2017 (estimated)
- First posted
- 6 Jun 2017 (actual)
- 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.
forty DLE lesions from patients will be recruited in the study. The lesions on one side of the body were block-randomized into the treatment group and the other side served as a control. The patients can continue their systemic treatments and the PDL is designed to be used as an adjunctive treatment. Treatments with the PDL will be delivered in the treatment group every 4 weeks for 4 consecutive months while the lesions in the control group received a sham. The patients will be evaluated at baseline (week 0), week 4, 8, 12, and at follow-up period of 4, 12 weeks after the final treatment (week 16, 24). Erythema index (EI), Texture index (TI) will be obtained and digital photographs will be taken and modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) will be assessed in every visit. The digital photographs will later be evaluated by 3-blinded dermatologists. Moreover, side effects and patients' satisfaction score will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser treated DLE lesions | Experimental | Device: Pulsed-dye LaserDLE which received the pulsed-dye laser |
| sham treated DLE lesions | Sham comparator | Device: ShamDLE which received the sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Has at least two DLE lesions, located in the same anatomical location of the body, which the different of mCLASI are not more than 1 point
- Dose not undergo any procedure or laser treatment within 4 weeks before entered the study
- Dose not received any localised therapy of DLE eg. topical corticosteriod/immunomodulator within 4 weeks before entered the study
- Dose not receive the topical chemical peeling within 4 weeks before entered the study
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- History of skin cancer
- History of photo allergy
- History of bleeding tendency
- History of abnormal wound healing
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 |
|---|---|---|
| Pulsed-dye Laser595 nm Pulsed-dye Laser; 7mm spot sizes, 6msec pulse durations, 8j/cm2 fluences, dynamic cooling device 30/20, 4 sessions with 4 weeks interval | Device | laser treated DLE lesions |
| ShamCryogen spray with the setting of dynamic cooling device 30/20 | Device | sham treated DLE lesions |
Primary outcome
erythema index (EI)
Time frame: week 0(baseline), 4, 8, 12, 16, 24
Comparing changes of EI from baseline between treated group and controlled group, measured by Antera 3D camera
3 secondary outcomes
modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI)
Time frame: week 0, 4, 8, 12, 16, 24
Physician Global Assessment (PGA) scores
Time frame: week 0, 4, 8, 12, 16, 24
texture index (TI)
Time frame: week 0, 4, 8, 12, 16, 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- 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.
Pawinee Rerknimitr, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pulsed-dye Laser in people with Lupus Erythematosus, Discoid, run by Chulalongkorn University at 1 site in Thailand.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jun 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pawinee Rerknimitr, MD (pawineererk@yahoo.co.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
erythema index (EI) (time frame: week 0(baseline), 4, 8, 12, 16, 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2017.