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

Prospective, Randomized, Controlled Split-Face Study of the Excel V 532nm KTP Laser for the Treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea

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.

Study Overview

• Status: Completed
• Conditions: Papulopustular Rosacea; Erythematotelangiectatic Rosacea
• Intervention / Treatment: Device: 532nm KTP Laser vs 595nm Pulse Dye Laser

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33173
      • Miami Dermatology & Laser Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 532nm KTP Laser vs 595nm Pulse Dye Laser; 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.

Device: 532nm KTP Laser vs 595nm Pulse Dye Laser; Intervention for the Cutera Excel V system is to cease treatment to any subject that is experiencing any adverse reaction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea	Measured for each treatment arm as assessed by the treating investigator using the Physician's Global Assessment Scale.	Day 0 and 16 weeks
Degree of improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea severity	Measured for each treatment arm as assessed by the treating investigator using the Rosacea Grading Scale.	Day 0 and 16 weeks
Degree of improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea	Measured for each treatment arm based on Subject's Global Assessment Scale.	Day 0, 4 weeks, 8 weeks, 16 weeks
Comparison of improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea between the treatment arms prior to the 2nd and 3rd treatment, and at 4-6 weeks post-final treatment as assessed using Subject's Comparative Face Assessment Scale.	Compare between two treatment arms assessed using Subject's Comparative Face Assessment Scale.	Day 0, 4 weeks, 8 weeks, 16 weeks
Subject satisfaction level	Compare each treatment arm using Subject Satisfaction Assessment	Day 0, 4 weeks, 8 weeks, 16 weeks
Change in Dermatology Life Quality Index	Post-final treatment as compared to baseline	Day 0 and 16 weeks
Spectrophotometer measurements	Change in lesion skin color (mean a* value) post-final treatment as compared to baseline for each treatment arm.	Day 0 and 16 weeks
Subject discomfort (pain)	Measured during each treatment using Mosby Pain Rating Scale for each treatment arm	Day 0, 4 weeks, 8 weeks
Adverse Events	Incidence and severity of adverse device effects for each treatment arm during the study period	Day 0, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Stephen Ronan, MD, study principal investigator

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Laser; PDL; 532nm; Excel V; Cutera; Laser Light; 595nm; Flash Lamp
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: C-14-EV04