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Evaluation of the New Laser PHOTOLASE PLV-585nm for the Treatment of Rosacea (ROSAPHOTOLASE)

Primary Purpose

Erythematotelangiectatic Rosacea

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Excel V 532nm (KTP) green Laser
PHOTOLASE PLV 585 nm yellow laser
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erythematotelangiectatic Rosacea focused on measuring 532 nm green Laser, 585 nm yellow laser, rosacea, telangiectasis score, skin disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Hop Claude Huriez Chu Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

532nm KTP Laser

585 nm yellow laser

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Measures of skin reaction for each treatment arm
Measured with a 4 points scale : no reaction, low, moderate and severe reaction
Pain evaluation during each treatment
Mosby Pain Rating Scale for each treatment arm
Change in lesion skin color in each treatment arm
Measured with Chroma-Meter CR400 (Konica Minolta), Mean a* value
Subject satisfaction level
Comparison of each treatment arm using Subject Overall Evolution Scale
Change in Life Quality
Comparison of Dermatology Life Quality Index
Practitioner's opinion
Comparison, for each treatment arm, of comfort of use, practicality, duration of treatment
Adverse Events
Incidence and severity of adverse effects, for each treatment arm, during the study period

Full Information

First Posted
October 12, 2018
Last Updated
February 28, 2022
Sponsor
University Hospital, Lille
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Medical Research Fund of the Tampere University Hospital, Finland
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1. Study Identification

Unique Protocol Identification Number
NCT03708263
Brief Title
Evaluation of the New Laser PHOTOLASE PLV-585nm for the Treatment of Rosacea
Acronym
ROSAPHOTOLASE
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
departure of Pr MORDON from the ONCOTHAI unit
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
September 14, 2021 (Actual)
Study Completion Date
September 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Medical Research Fund of the Tampere University Hospital, Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythematotelangiectatic Rosacea
Keywords
532 nm green Laser, 585 nm yellow laser, rosacea, telangiectasis score, skin disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
532nm KTP Laser
Arm Type
Active Comparator
Arm Description
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.
Arm Title
585 nm yellow laser
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Excel V 532nm (KTP) green Laser
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
PHOTOLASE PLV 585 nm yellow laser
Intervention Description
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
Primary Outcome Measure Information:
Title
Degree of improvement in Erythematotelangiectatic Rosacea
Description
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)
Time Frame
at Month 2
Secondary Outcome Measure Information:
Title
Degree of improvement in Erythematotelangiectatic Rosacea evaluated by a blinded physician.
Description
Measured, for each treatment arm, based on subject photographs using the 7 points Telangiectasia Grading Score
Time Frame
at Month 4, 6,12
Title
Measures of skin reaction for each treatment arm
Description
Measured with a 4 points scale : no reaction, low, moderate and severe reaction
Time Frame
At baseline, At Month 2, At Month 4 (if realized)
Title
Pain evaluation during each treatment
Description
Mosby Pain Rating Scale for each treatment arm
Time Frame
At baseline, At Month 2, At Month 4 (if realized)
Title
Change in lesion skin color in each treatment arm
Description
Measured with Chroma-Meter CR400 (Konica Minolta), Mean a* value
Time Frame
At Baseline, at Month 2, 4, 6,12
Title
Subject satisfaction level
Description
Comparison of each treatment arm using Subject Overall Evolution Scale
Time Frame
At Month 6,12
Title
Change in Life Quality
Description
Comparison of Dermatology Life Quality Index
Time Frame
At Selection, at Baseline, at Month 2, 4 (if realized), 6,12
Title
Practitioner's opinion
Description
Comparison, for each treatment arm, of comfort of use, practicality, duration of treatment
Time Frame
At baseline, At Month 2, At Month 4 (if realized)
Title
Adverse Events
Description
Incidence and severity of adverse effects, for each treatment arm, during the study period
Time Frame
At Baseline, At Month 2, 4, 6,12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyril MAIRE, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Serge MORDON, Pr
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Study Director
Facility Information:
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

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Evaluation of the New Laser PHOTOLASE PLV-585nm for the Treatment of Rosacea

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