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

NCT02268474 | Completed Results

• 1 other identifier: C-14-EV04
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Erythematotelangiectatic Rosacea; Papulopustular Rosacea

Keywords

532nm; Excel V; Cutera; Laser; Laser Light; PDL; 595nm; Flash Lamp

Outcome Measures

Primary Outcomes (1)

• 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) 1. = \< 25% Improvement (Mild) 2. = 26 to 50% Improvement (Moderate) 3. = 51 to 75% Improvement (Significant) 4. = 76 to 100% Improvement (Very Significant)

  6 weeks

Study Arms (1)

532nm KTP Laser vs 595nm Pulse Dye Laser

EXPERIMENTAL

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: 1. Treatment arm involving treatments with 532nm KTP laser 2. 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

Interventions

532nm KTP Laser vs 595nm Pulse Dye Laser DEVICE

Intervention for the Cutera Excel V system is to cease treatment to any subject that is experiencing any adverse reaction.

532nm KTP Laser vs 595nm Pulse Dye Laser

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

Miami Dermatology & Laser Institute

Miami, Florida, 33173, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-657-5518

Study Officials

• Stephen Ronan, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 20, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-01

Locations

US (1)