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

NCT03708263 | Terminated DMC

• 2 other identifiers: 2017_572018-A01904-51
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Erythematotelangiectatic Rosacea

Keywords

532 nm green Laser; 585 nm yellow laser; rosacea; telangiectasis score; skin disease

Outcome Measures

Primary Outcomes (1)

• 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)

  at Month 2

Secondary Outcomes (8)

• Degree of improvement in Erythematotelangiectatic Rosacea evaluated by a blinded physician.

  at Month 4, 6,12

• Measures of skin reaction for each treatment arm

  At baseline, At Month 2, At Month 4 (if realized)

• Pain evaluation during each treatment

  At baseline, At Month 2, At Month 4 (if realized)

• Change in lesion skin color in each treatment arm

  At Baseline, at Month 2, 4, 6,12

• Subject satisfaction level

  At Month 6,12

Study Arms (2)

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.

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.

Device: PHOTOLASE PLV 585 nm yellow laser

Interventions

Excel V 532nm (KTP) green Laser DEVICE

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

532nm KTP Laser

PHOTOLASE PLV 585 nm yellow laser DEVICE

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

585 nm yellow laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Medical Research Fund of the Tampere University Hospital, Finland: collaborator

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Rosacea; Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Cyril MAIRE, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

• Serge MORDON, Pr

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 17, 2018
• Study Start: September 8, 2020
• Primary Completion: September 14, 2021
• Study Completion: September 14, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-02

Locations

FR (1)