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Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea

Primary Purpose

Erythematotelangiectatic Rosacea, Papulopustular Rosacea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
532nm KTP Laser vs 595nm Pulse Dye Laser
Sponsored by
Cutera Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erythematotelangiectatic Rosacea focused on measuring 532nm, Excel V, Cutera, Laser, Laser Light, PDL, 595nm, Flash Lamp

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Females or Males, 20 to 80 years of age (inclusive).
  2. Fitzpatrick Skin Type I - III.
  3. Clinical diagnosis of Erythematotelangiectatic Rosacea and Papulopustular Rosacea.
  4. Willing to refrain from using systemic corticosteroids or retinoids; or topical corticosteroids or retinoids on the treated area.
  5. Must be able to read, understand and sign the Informed Consent Form.
  6. Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
  7. 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.
  8. Willingness to have digital photographs taken of the face.
  9. Agree not to undergo any other procedure for the treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea during the study.
  10. 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.

Exclusion Criteria:

  1. History of prior laser or light based procedures for the face within 6 months of study participation.
  2. Fitzpatrick Skin Type IV - VI.
  3. Pregnant and/or breastfeeding.
  4. Subject is less than 20 years of age or greater than 80 years of age.
  5. Having an infection, dermatitis or rash in the treatment area.
  6. Suffering from significant concurrent illness, such as diabetes mellitus, cardiovascular disease, uncontrolled hypertension, or pertinent neurological disorders.
  7. History of keloid formation, hypertrophic scarring or of abnormal wound healing.
  8. History of immunosuppression/immune deficiency disorders such as psoriasis, eczema, vitiligo, or currently using immunosuppressive medications.
  9. Malignant tumors in the target area or history of a malignant skin disease.
  10. History of fibromyalgia.
  11. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
  12. Having a known anticoagulative condition or taking prescription anticoagulation medications.
  13. History of seizure disorders due to light.
  14. Any current use of medication that is known to increase sensitivity to light, such as tetracycline.
  15. 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.
  16. Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely).
  17. History of radiation to the head, neck and/or upper chest.
  18. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
  19. Undergoing systemic chemotherapy for the treatment of cancer.
  20. Systemic use of retinoid such as isotretinoin and/or corticosteroid within 6 months.
  21. Topical use of retinoid and/or corticosteroid within 4 weeks of study participation.
  22. Any use of gold therapy for disorders such as rheumatologic disease or lupus.
  23. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  24. Current smoker or history of smoking within 12 months of study participation.
  25. Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
  26. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Sites / Locations

  • Miami Dermatology & Laser Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

532nm KTP Laser vs 595nm Pulse Dye Laser

Arm Description

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: Treatment arm involving treatments with 532nm KTP laser 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 15, 2014
Last Updated
January 26, 2023
Sponsor
Cutera Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02268474
Brief Title
Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea
Official Title
Prospective, Randomized, Controlled Split-Face Study of the Excel V 532nm KTP Laser for the Treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cutera Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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: 1) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythematotelangiectatic Rosacea, Papulopustular Rosacea
Keywords
532nm, Excel V, Cutera, Laser, Laser Light, PDL, 595nm, Flash Lamp

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
532nm KTP Laser vs 595nm Pulse Dye Laser
Arm Type
Experimental
Arm Description
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: Treatment arm involving treatments with 532nm KTP laser 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.
Intervention Type
Device
Intervention Name(s)
532nm KTP Laser vs 595nm Pulse Dye Laser
Intervention Description
Intervention for the Cutera Excel V system is to cease treatment to any subject that is experiencing any adverse reaction.
Primary Outcome Measure Information:
Title
Degree of Improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea
Description
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)
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Ronan, MD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Dermatology & Laser Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea

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