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

NCT03708263 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-03-15

No results posted yet for this study

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

Interventions

DEVICE

Excel V 532nm (KTP) green Laser

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

DEVICE

PHOTOLASE PLV 585 nm yellow laser

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

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • Medical Research Fund of the Tampere University Hospital, Finland

    collaborator OTHER

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Cyril MAIRE, MD · University Hospital, Lille

  • Serge MORDON, Pr · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2021-09-14
Completion
2021-09-14

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03708263 on ClinicalTrials.gov