Erythematotelangiectatic Rosacea, Papulopustular Rosacea
Conditions
Keywords
532nm, Excel V, Cutera, Laser, Laser Light, PDL, 595nm, Flash Lamp
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.
Interventions
DEVICE532nm 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.
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea | 6 weeks | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects Cutera® Excel V
Excel V 532nm (KTP) Laser or 595nm Pulse Dye 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 treatment (532nm KTP laser) and active control treatment (595nm PDL) arms will be determined by randomization. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 22 / 22 | 22 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
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)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 532nm KTP Laser | Degree of Improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea | 2.114 score on a scale | Standard Deviation 1.5125 |
| 595nm Pulse Dye Laser | Degree of Improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea | 2.088 score on a scale | Standard Deviation 1.681 |