Erythematotelangiectatic RosaceaNCT02268474
Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea
A study testing 532nm KTP Laser vs 595nm Pulse Dye Laser in people with Erythematotelangiectatic Rosacea and Papulopustular Rosacea, run by Cutera Inc. at 1 site in United States.
Trial summary
A single center prospective, randomized, controlled split face study comparing a 532nm KTP laser with a 595nm PDL for the treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea. Subjects will receive laser treatments and will be followed at 6 weeks post-final laser treatment. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Erythematotelangiectatic Rosacea, Papulopustular Rosacea
- What is being tested?
- 532nm KTP Laser vs 595nm Pulse Dye Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2015
- 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 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females or Males, 20 to 80 years of age (inclusive).
- Fitzpatrick Skin Type I - III.
- Clinical diagnosis of Erythematotelangiectatic Rosacea and Papulopustular Rosacea.
- Willing to refrain from using systemic corticosteroids or retinoids; or topical corticosteroids or retinoids on the treated area.
- Must be able to read, understand and sign the Informed Consent Form.
- Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
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- Wiling to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the face every day for the duration of the study, including the follow-up period.
- Willingness to have digital photographs taken of the face.
- Agree not to undergo any other procedure for the treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea during the study.
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.
Who cannot join
- History of prior laser or light based procedures for the face within 6 months of study participation.
- Fitzpatrick Skin Type IV - VI.
- Pregnant and/or breastfeeding.
- Subject is less than 20 years of age or greater than 80 years of age.
- Having an infection, dermatitis or rash in the treatment area.
- Suffering from significant concurrent illness, such as diabetes mellitus, cardiovascular disease, uncontrolled hypertension, or pertinent neurological disorders.
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- History of keloid formation, hypertrophic scarring or of abnormal wound healing.
- History of immunosuppression/immune deficiency disorders such as psoriasis, eczema, vitiligo, or currently using immunosuppressive medications.
- Malignant tumors in the target area or history of a malignant skin disease.
- History of fibromyalgia.
- History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- Having a known anticoagulative condition or taking prescription anticoagulation medications.
- History of seizure disorders due to light.
- Any current use of medication that is known to increase sensitivity to light, such as tetracycline.
- Having a history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area, unless treatment is conducted following a prophylactic regimen.
- Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely).
- History of radiation to the head, neck and/or upper chest.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Undergoing systemic chemotherapy for the treatment of cancer.
- Systemic use of retinoid such as isotretinoin and/or corticosteroid within 6 months.
- Topical use of retinoid and/or corticosteroid within 4 weeks of study participation.
- Any use of gold therapy for disorders such as rheumatologic disease or lupus.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Current smoker or history of smoking within 12 months of study participation.
- Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Dermatology & Laser Institute
Miami, Florida, 33173
About this study
Official title: Prospective, Randomized, Controlled Split-Face Study of the Excel V 532nm KTP Laser for the Treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea
A single center prospective, randomized, controlled split face study comparing a 532nm KTP laser with a 595nm PDL for the treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea.
Subjects will receive laser treatments and will be followed at 6 weeks post-final laser treatment.
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of the 532nm KTP laser within the Cutera® Excel V system for the treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea as compared to a 595nm Pulse Dye Laser.
The objectives of this study are:
- To evaluate and compare the safety and efficacy of the laser treatments for Erythematotelangiectatic Rosacea and Papulopustular Rosacea at 6 weeks post final laser treatment.
- Being tested
- 532nm KTP Laser vs 595nm Pulse Dye Laser
- Keywords
- 532nm, Excel V, Cutera, Laser, Laser Light, PDL, 595nm, Flash Lamp
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
532nm KTP Laser vs 595nm Pulse Dye LaserDevice
Intervention for the Cutera Excel V system is to cease treatment to any subject that is experiencing any adverse reaction.
| Study group | Role | What they receive |
|---|---|---|
| 532nm KTP Laser vs 595nm Pulse Dye Laser | Experimental | This is a single-center prospective, randomized, controlled split-face study in 20 subjects diagnosed with Erythematotelangiectatic Rosacea and/or Papulopustular Rosacea.
This two arm, split-face study will consist of:
1. Treatment arm involving treatments with 532nm KTP laser
2. Active control arm involving treatments with 595nm Pulse Dye Laser (PDL)
Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of treatment (532nm KTP laser) and active control treatment (595nm PDL) arms will be determined by randomization. Receives: Device: 532nm KTP Laser vs 595nm Pulse Dye Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea
Measured for each treatment arm based on blinded physician assessment of subject photographs using the Physician's Global Assessment Scale (min=0; max=4) Higher scores mean better improvement 0 = 0% Improvement (None)
- = < 25% Improvement (Mild)
- = 26 to 50% Improvement (Moderate)
- = 51 to 75% Improvement (Significant)
- = 76 to 100% Improvement (Very Significant)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionAug 2015
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 Erythematotelangiectatic RosaceaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Ronan, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268474
- Sponsor's protocol ID
- C-14-EV04
- Status last verified
- Jan 2023
- First submitted
- 15 Oct 2014
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Split-Face Study of the Excel V 532nm KTP Laser for the Treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT02268474
- Acronym / sponsor ID
- C-14-EV04
- Keywords
- 532nm, Excel V, Cutera, Laser, Laser Light, PDL, 595nm, Flash Lamp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single center prospective, randomized, controlled split face study comparing a 532nm KTP laser with a 595nm PDL for the treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea.
Subjects will receive laser treatments and will be followed at 6 weeks post-final laser treatment.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of the 532nm KTP laser within the Cutera® Excel V system for the treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea as compared to a 595nm Pulse Dye Laser.
The objectives of this study are:
- To evaluate and compare the safety and efficacy of the laser treatments for Erythematotelangiectatic Rosacea and Papulopustular Rosacea at 6 weeks post final laser treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 532nm KTP Laser vs 595nm Pulse Dye Laser | Experimental | Device: 532nm KTP Laser vs 595nm Pulse Dye LaserThis is a single-center prospective, randomized, controlled split-face study in 20 subjects diagnosed with Erythematotelangiectatic Rosacea and/or Papulopustular Rosacea. This two arm, split-face study will consist of: 1. Treatment arm involving treatments with 532nm KTP laser 2. Active control arm involving treatments with 595nm Pulse Dye Laser (PDL) Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of treatment (532nm KTP laser) and active control treatment (595nm PDL) arms will be determined by randomization. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Females or Males, 20 to 80 years of age (inclusive).
- Fitzpatrick Skin Type I - III.
- Clinical diagnosis of Erythematotelangiectatic Rosacea and Papulopustular Rosacea.
- Willing to refrain from using systemic corticosteroids or retinoids; or topical corticosteroids or retinoids on the treated area.
- Must be able to read, understand and sign the Informed Consent Form.
Key exclusion criteria (26 listed)
- History of prior laser or light based procedures for the face within 6 months of study participation.
- Fitzpatrick Skin Type IV - VI.
- Pregnant and/or breastfeeding.
- Subject is less than 20 years of age or greater than 80 years of age.
- Having an infection, dermatitis or rash in the treatment area.
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 KTP Laser vs 595nm Pulse Dye LaserIntervention for the Cutera Excel V system is to cease treatment to any subject that is experiencing any adverse reaction. | Device | 532nm KTP Laser vs 595nm Pulse Dye Laser |
Primary outcome
Degree of Improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea
Time frame: 6 weeks
Measured for each treatment arm based on blinded physician assessment of subject photographs using the Physician's Global Assessment Scale (min=0; max=4) Higher scores mean better improvement 0 = 0% Improvement (None) 1. = < 25% Improvement (Mild) 2. = 26 to 50% Improvement (Moderate) 3. = 51 to 75% Improvement (Significant) 4. = 76 to 100% Improvement (Very Significant)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- 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.
Stephen Ronan, MD principal investigator
Study Principal Investigator
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 KTP Laser vs 595nm Pulse Dye Laser in people with Erythematotelangiectatic Rosacea and Papulopustular Rosacea, run by Cutera Inc. 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 10 inclusion and 26 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 21 Feb 2023. 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 Feb 2023). 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?
Degree of Improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea (time frame: 6 weeks). 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 Feb 2023.