Cutaneous LupusNCT03639857
Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone
A study testing 532nm laser, 1064nm laser and Topical corticosteroid in people with Cutaneous Lupus, run by David Weinstein at 1 site in United States.
Trial summary
This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus versus topical corticosteroids alone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Lupus
- What is being tested?
- 532nm laser, 1064nm laser and Topical corticosteroid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female adult 18 years of age or older
- Ability to rate level of pain
- Ability to rate visual satisfaction
- At least 2 active lesions of CLE
Who cannot join
- New or change in systemic medication for cutaneous lupus in past 6 months
- Allergy to triamcinolone or betamethasone dipropionate cream
- Pregnancy
- Currently a prisoner
- Unable to read and speak English since consent will only be available in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone
This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus versus topical corticosteroids alone.
- Conditions
- Cutaneous Lupus
- Being tested
- 532nm laser, 1064nm laser, Topical corticosteroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
532nm laserDevice
532nm laser will be used to treat the lesion in this study arm.
1064nm laserDevice
1064nm laser will be used to treat the lesion in this study arm.
Topical corticosteroidDrug
The topical corticosteroid will be used to treat the lesion in this study arm.
| Study group | Role | What they receive |
|---|---|---|
| 532nm laser and topical corticosteroid | Experimental | 532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. Receives: Device: 532nm laser; Drug: Topical corticosteroid |
| 1064nm laser and topical corticosteroid | Experimental | 1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. Receives: Device: 1064nm laser; Drug: Topical corticosteroid |
| Topical corticosteroid alone | Active comparator | Topical corticosteroid is applied to the patient's lesion. Receives: Drug: Topical corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limited CLASI
The investigators are using a limited Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scoring system to classify specific lesions the investigators are measuring. The total limited CLASI reflects the sum of both active and damage CLASI, resulting in a score ranging from 0 to 8. A higher score indicates more severe disease. Score is assessed by the investigators.
The limited active CLASI for a lesion will include the following:
- Erythema (ranging from 0 = absent to 3 = dark red/purple)
- Scale/Hypertrophy (ranging from 0 = absent to 2 = verrucous/ hypertrophic)
- The addition of these scores result in a total limited active CLASI score of the studied lesion, ranging from 0 to 5.
The limited damage CLASI for a lesion will include the following:
- Dyspigmentation (0 = absent or 1 = present)
- Scarring/Atrophy/Panniculitis (ranging from 0 = absent to 2 = severely atrophic scarring or panniculitis).
- The addition of these scores result in a
Measured: 2 Months
VAS for Appearance
The investigators are using a VAS (visual analog scale) to measure patient assessment of the appearance of the lesion. The scale ranges from 0-10, with 10 being very satisfied and 0 being no satisfaction at all.
A score of 0 will represent a cosmetically fully unsatisfactory result and 10 will represent cosmetically excellent result.
Measured: 2 Months
VAS for Pain
The investigators are using a VAS (visual analog scale) to assess pain of the laser treatment. The participant rates the pain of the laser treatment. The scale ranges from 0 (no pain) to 10(worse pain).
A score of 0 will represent absence of pain and 10 will represent maximal pain.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start17 Aug 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Time and resource constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cutaneous LupusStudies 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
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Weinstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Weinstein, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639857
- Sponsor's protocol ID
- BIO-17-13680
- Status last verified
- Jun 2021
- First submitted
- 17 Aug 2018
- Last updated
- 21 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone
- ClinicalTrials.gov ID
- NCT03639857
- Acronym / sponsor ID
- BIO-17-13680
- Conditions
- Cutaneous Lupus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Time and resource constraints
- Enrolment
- 3 participants (actual)
- Lead sponsor
- David WeinsteinUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 21 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus versus topical corticosteroids alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 532nm laser and topical corticosteroid | Experimental | Device: 532nm laser, Drug: Topical corticosteroid532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. |
| 1064nm laser and topical corticosteroid | Experimental | Device: 1064nm laser, Drug: Topical corticosteroid1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. |
| Topical corticosteroid alone | Active comparator | Drug: Topical corticosteroidTopical corticosteroid is applied to the patient's lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female adult 18 years of age or older
- Ability to rate level of pain
- Ability to rate visual satisfaction
- At least 2 active lesions of CLE
Key exclusion criteria (5 listed)
- New or change in systemic medication for cutaneous lupus in past 6 months
- Allergy to triamcinolone or betamethasone dipropionate cream
- Pregnancy
- Currently a prisoner
- Unable to read and speak English since consent will only be available in English
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 |
|---|---|---|
| 532nm laser532nm laser will be used to treat the lesion in this study arm. | Device | 532nm laser and topical corticosteroid |
| 1064nm laser1064nm laser will be used to treat the lesion in this study arm. | Device | 1064nm laser and topical corticosteroid |
| Topical corticosteroidThe topical corticosteroid will be used to treat the lesion in this study arm. | Drug | 1064nm laser and topical corticosteroid, 532nm laser and topical corticosteroid, Topical corticosteroid alone |
Primary outcome
Limited CLASI
Time frame: 2 Months
The investigators are using a limited Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scoring system to classify specific lesions the investigators are measuring. The total limited CLASI reflects the sum of both active and damage CLASI, resulting in a score ranging from 0 to 8. A higher score indicates more severe disease. Score is assessed by the investigators. The limited active CLASI for a lesion will include the following: * Erythema (ranging from 0 = absent to 3 = dark red/purple) * Scale/Hypertrophy (ranging from 0 = absent to 2 = verrucous/ hypertrophic) * The addition of these scores result in a total limited active CLASI score of the studied lesion, ranging from 0 to 5. The limited damage CLASI for a lesion will include the following: * Dyspigmentation (0 = absent or 1 = present) * Scarring/Atrophy/Panniculitis (ranging from 0 = absent to 2 = severely atrophic scarring or panniculitis). * The addition of these scores result in a
VAS for Appearance
Time frame: 2 Months
The investigators are using a VAS (visual analog scale) to measure patient assessment of the appearance of the lesion. The scale ranges from 0-10, with 10 being very satisfied and 0 being no satisfaction at all. A score of 0 will represent a cosmetically fully unsatisfactory result and 10 will represent cosmetically excellent result.
VAS for Pain
Time frame: 1 Month
The investigators are using a VAS (visual analog scale) to assess pain of the laser treatment. The participant rates the pain of the laser treatment. The scale ranges from 0 (no pain) to 10(worse pain). A score of 0 will represent absence of pain and 10 will represent maximal pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 532nm laser, 1064nm laser and Topical corticosteroid in people with Cutaneous Lupus, run by David Weinstein at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 21 Jul 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Limited CLASI (time frame: 2 Months). The study lists 3 primary outcomes in all. 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 21 Jul 2021.