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

Papulopustular Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268474
• Other study ID #: C-14-EV04
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: January 2023
• Source: Cutera Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erythematotelangiectatic Rosacea
• Papulopustular Rosacea
• Rosacea

Intervention

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.

Locations

Country	Name	City	State
United States	Miami Dermatology & Laser Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cutera Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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); = < 25% Improvement (Mild); = 26 to 50% Improvement (Moderate); = 51 to 75% Improvement (Significant); = 76 to 100% Improvement (Very Significant)	6 weeks