Erythematotelangiectatic RosaceaROSAPHOTOLASENCT03708263
Evaluation of the New Laser PHOTOLASE PLV-585nm for the Treatment of Rosacea
A study testing Excel V 532nm (KTP) green Laser and PHOTOLASE PLV 585 nm yellow laser in people with Erythematotelangiectatic Rosacea, run by University Hospital, Lille at 1 site in France.
Trial summary
Rosacea is a frequent dermatological condition, with a chronic and disturbing evolution that is characterized by redness, permanent erythema associated with telangiectasia (visible and permanent dilatation of the small vessels). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erythematotelangiectatic Rosacea
- What is being tested?
- Excel V 532nm (KTP) green Laser and PHOTOLASE PLV 585 nm yellow laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2020to 14 Sep 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fitzpatrick Skin Type I - III
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrolment and during the entire course of the study.
- Clinical diagnosis of Erythematotelangiectatic Rosacea stade II
- Homogeneous extend and staining telangiectasia in each half face
- Patient never treated with laser for Rosacea
- Patient doesn't wish to use systemic corticosteroids or retinoids; or topical corticosteroids or retinoids on the treated area.
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- Patient agreeing to have limited exposure to the sun and use of a protective screen (index 50 or higher) every day of the study and throughout its duration if it takes place from May to September.
- Patient must be able to read, understand and sign the Informed Consent Form
- Patient able to adhere to the program of visits of the study and the other imperatives of the protocol
- Patient accepting to have photographs taken on the face
- Quality of social insurance or social security entitlement
Who cannot join
- Pregnant and/or breastfeeding woman or childbearing age without effective contraception
- Alcohol abuse assessed at the discretion of the investigator
- History of prior laser or light based procedures for any other pathology for the face within 6 months of study participation Fitzpatrick Type IV à VI
- Systemic use of isotretinoin in the 6 months prior to inclusion in the study.
- Topical use of retinoids and / or corticosteroids in the 4 weeks prior to inclusion in the study.
- Patient under photo sensitization treatment
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- Patient suffering from significant concurrent illness such as type 1 diabetes, cardiovascular disease, uncontrolled hypertension, neurological disease, lupus erythematosus, scleroderma.
- Patient subject to hypertrophic or abnormal scarring
- Patient presenting or having a malignant tumor or skin cancer in the area to be treated.
- Having a known anticoagulative condition or taking prescription anticoagulation medications.
- Participation to another clinical study involving a laser or drug within three months of inclusion in the study.
- Smoker or former smoker in the 12 months prior to inclusion in the study.
- Patient with excessive tattoos in the area to be treated and / or wishing to tattoo the treated area during the study.
- Patient treated for cancer by chemotherapy or radiotherapy
- Patient with hyper or hypo pigmentation
- Patient unable to understand protocol or give consent
- Legal incapacity (persons deprived of their liberty or under guardianship or curatorship)
- Patient in emergency or in detention
- Clinical follow-up impossible for psychological, family matters, social or geographical reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blinded, Monocentric, Randomized Pilot Study, to Evaluate the Yellow Laser PHOTOLASE PLV-585nm Versus the Reference Green Laser (KTP Excel V 532 nm) in the Treatment of Erythematotelangiectatic Rosacea
Rosacea is a frequent dermatological condition, with a chronic and disturbing evolution that is characterized by redness, permanent erythema associated with telangiectasia (visible and permanent dilatation of the small vessels). It frequently affects men and women with fair skin and can have significant psycho-emotional consequences.
To counteract the unaesthetic appearance of redness and eliminate telangiectasia, the use of the laser is proposed to the patient.
This study is a single center prospective, randomized, controlled split face study to compare 532nm KTP laser versus 585 nm PLV Laser in terms of improvement of the symptoms in the treatment of Erythematotelangiectatic Rosacea 20 subjects will receive up to 3 laser treatments at day 0, month 2 and 4 and will be followed at month 6 and 12.
Read the detailed description
Adult male and female subjects 18 years of age or older will participate in the study after the objectives, methods, and potential risks of the study have been explained, and after they have signed the informed consent form.
Patients will come to the investigation center for a maximum of 6 visits.
- Conditions
- Erythematotelangiectatic Rosacea
- Being tested
- Excel V 532nm (KTP) green Laser, PHOTOLASE PLV 585 nm yellow laser
- Keywords
- 532 nm green Laser, 585 nm yellow laser, rosacea, telangiectasis score, skin disease
- Medical subject headings
- Rosacea, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excel V 532nm (KTP) green LaserDevice
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 active comparator and experimental treatment arms will be determined by randomization
PHOTOLASE PLV 585 nm yellow laserDevice
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 active comparator and experimental treatment arms will be determined by randomization
| Study group | Role | What they receive |
|---|---|---|
| 532nm KTP Laser | Active comparator | Cutera® Excel V 532 nm Application of light spots 5 to 7 mm for a pulse duration of 8 to 20 ms and a fluence of 7.4 to 10 J / cm2. Receives: Device: Excel V 532nm (KTP) green Laser |
| 585 nm yellow laser | Experimental | PHOTOLASE PLV 585 nm Application of light spots 1.4mm for a pulse duration of 10 to 100 ms and a fluence of 0 to 65 J / cm2. Receives: Device: PHOTOLASE PLV 585 nm yellow laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of improvement in Erythematotelangiectatic Rosacea
Measured, for each treatment arm, based on blinded physician assessment of subject photographs using the 7 points Telangiectasia Grading Score.
(-1 = Aggravation of telangiectasia, 0 = no change, 1 = poor improvement (<25% decrease), 2 = intermediate improvement (25-50% decrease), 3 significant improvement (50-75% decrease), 4 = very significant improvement (75-99% decrease), 5 = complete improvement (100% decrease)
Measured: at Month 2
Secondary outcomes (8)
Degree of improvement in Erythematotelangiectatic Rosacea evaluated by a blinded physician.
Measured, for each treatment arm, based on subject photographs using the 7 points Telangiectasia Grading Score
Measured: at Month 4, 6,12
Measures of skin reaction for each treatment arm
Measured with a 4 points scale : no reaction, low, moderate and severe reaction
Measured: At baseline, At Month 2, At Month 4 (if realized)
Pain evaluation during each treatment
Mosby Pain Rating Scale for each treatment arm
Measured: At baseline, At Month 2, At Month 4 (if realized)
Change in lesion skin color in each treatment arm
Measured with Chroma-Meter CR400 (Konica Minolta), Mean a* value
Measured: At Baseline, at Month 2, 4, 6,12
Subject satisfaction level
Comparison of each treatment arm using Subject Overall Evolution Scale
Measured: At Month 6,12
Change in Life Quality
Comparison of Dermatology Life Quality Index
Measured: At Selection, at Baseline, at Month 2, 4 (if realized), 6,12
Practitioner's opinion
Comparison, for each treatment arm, of comfort of use, practicality, duration of treatment
Measured: At baseline, At Month 2, At Month 4 (if realized)
Adverse Events
Incidence and severity of adverse effects, for each treatment arm, during the study period
Measured: At Baseline, At Month 2, 4, 6,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start8 Sep 2020
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
Why it stopped: departure of Pr MORDON from the ONCOTHAI unit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Tampere University Hospital
- Responsible party
- Sponsor
- Investigators
- Cyril MAIRE, MD, Principal investigator, University Hospital, LilleSerge MORDON, Pr, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708263
- Sponsor's protocol ID
- 2017_57
- Other IDs
- 2018-A01904-51
- Acronym
- ROSAPHOTOLASE
- Status last verified
- Feb 2022
- First submitted
- 12 Oct 2018
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blinded, Monocentric, Randomized Pilot Study, to Evaluate the Yellow Laser PHOTOLASE PLV-585nm Versus the Reference Green Laser (KTP Excel V 532 nm) in the Treatment of Erythematotelangiectatic Rosacea
- ClinicalTrials.gov ID
- NCT03708263
- Acronym / sponsor ID
- ROSAPHOTOLASE / 2017_57
- Conditions
- Erythematotelangiectatic Rosacea
- Keywords
- 532 nm green Laser, 585 nm yellow laser, rosacea, telangiectasis score, skin disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: departure of Pr MORDON from the ONCOTHAI unit
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Tampere University Hospital
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 17 Oct 2018 (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.
Rosacea is a frequent dermatological condition, with a chronic and disturbing evolution that is characterized by redness, permanent erythema associated with telangiectasia (visible and permanent dilatation of the small vessels). It frequently affects men and women with fair skin and can have significant psycho-emotional consequences.
To counteract the unaesthetic appearance of redness and eliminate telangiectasia, the use of the laser is proposed to the patient.
This study is a single center prospective, randomized, controlled split face study to compare 532nm KTP laser versus 585 nm PLV Laser in terms of improvement of the symptoms in the treatment of Erythematotelangiectatic Rosacea 20 subjects will receive up to 3 laser treatments at day 0, month 2 and 4 and will be followed at month 6 and 12.
Detailed description
Adult male and female subjects 18 years of age or older will participate in the study after the objectives, methods, and potential risks of the study have been explained, and after they have signed the informed consent form.
Patients will come to the investigation center for a maximum of 6 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 532nm KTP Laser | Active comparator | Device: Excel V 532nm (KTP) green LaserCutera® Excel V 532 nm Application of light spots 5 to 7 mm for a pulse duration of 8 to 20 ms and a fluence of 7.4 to 10 J / cm2. |
| 585 nm yellow laser | Experimental | Device: PHOTOLASE PLV 585 nm yellow laserPHOTOLASE PLV 585 nm Application of light spots 1.4mm for a pulse duration of 10 to 100 ms and a fluence of 0 to 65 J / cm2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Fitzpatrick Skin Type I - III
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrolment and during the entire course of the study.
- Clinical diagnosis of Erythematotelangiectatic Rosacea stade II
- Homogeneous extend and staining telangiectasia in each half face
- Patient never treated with laser for Rosacea
Key exclusion criteria (19 listed)
- Pregnant and/or breastfeeding woman or childbearing age without effective contraception
- Alcohol abuse assessed at the discretion of the investigator
- History of prior laser or light based procedures for any other pathology for the face within 6 months of study participation Fitzpatrick Type IV à VI
- Systemic use of isotretinoin in the 6 months prior to inclusion in the study.
- Topical use of retinoids and / or corticosteroids in the 4 weeks prior to inclusion in the study.
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 |
|---|---|---|
| Excel V 532nm (KTP) green LaserEach 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 active comparator and experimental treatment arms will be determined by randomization | Device | 532nm KTP Laser |
| PHOTOLASE PLV 585 nm yellow laserEach 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 active comparator and experimental treatment arms will be determined by randomization | Device | 585 nm yellow laser |
Primary outcome
Degree of improvement in Erythematotelangiectatic Rosacea
Time frame: at Month 2
Measured, for each treatment arm, based on blinded physician assessment of subject photographs using the 7 points Telangiectasia Grading Score. (-1 = Aggravation of telangiectasia, 0 = no change, 1 = poor improvement (<25% decrease), 2 = intermediate improvement (25-50% decrease), 3 significant improvement (50-75% decrease), 4 = very significant improvement (75-99% decrease), 5 = complete improvement (100% decrease)
8 secondary outcomes
Degree of improvement in Erythematotelangiectatic Rosacea evaluated by a blinded physician.
Time frame: at Month 4, 6,12
Measures of skin reaction for each treatment arm
Time frame: At baseline, At Month 2, At Month 4 (if realized)
Pain evaluation during each treatment
Time frame: At baseline, At Month 2, At Month 4 (if realized)
Change in lesion skin color in each treatment arm
Time frame: At Baseline, at Month 2, 4, 6,12
Subject satisfaction level
Time frame: At Month 6,12
Change in Life Quality
Time frame: At Selection, at Baseline, at Month 2, 4 (if realized), 6,12
Practitioner's opinion
Time frame: At baseline, At Month 2, At Month 4 (if realized)
Adverse Events
Time frame: At Baseline, At Month 2, 4, 6,12
Results and safety
The study was stopped early (reason given: departure of Pr MORDON from the ONCOTHAI unit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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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.
Cyril MAIRE, MD principal investigator
University Hospital, Lille
Serge MORDON, Pr study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excel V 532nm (KTP) green Laser and PHOTOLASE PLV 585 nm yellow laser in people with Erythematotelangiectatic Rosacea, run by University Hospital, Lille at 1 site in France.
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 11 inclusion and 19 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 15 Mar 2022. 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 France. 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 was stopped early (reason given: departure of Pr MORDON from the ONCOTHAI unit). Results are not available in the source record.
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 (time frame: at Month 2). 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 15 Mar 2022.