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

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ClinicalTrials.gov Identifier: NCT02268474
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

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 up to 3 laser treatments 4 weeks apart and will be followed at 4 to 6 weeks post-final laser treatment.


Condition or disease Intervention/treatment Phase
Erythematotelangiectatic Rosacea Papulopustular Rosacea Device: Excel V 532nm (KTP) Laser or 595nm Pulse Dye Laser Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: 532nm KTP Laser
Cutera® Excel V
Device: 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.

Active Comparator: 595nm Pulse Dye Laser
Candela/Syneron Vbeam
Device: 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.




Primary Outcome Measures :
  1. Degree of improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea [ Time Frame: Day 0, 4 weeks and 8 weeks ]
    Measured for each treatment arm based on blinded physician assessment of subject photographs using the Physician's Global Assessment Scale.


Secondary Outcome Measures :
  1. Degree of improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea [ Time Frame: Day 0 and 16 weeks ]
    Measured for each treatment arm as assessed by the treating investigator using the Physician's Global Assessment Scale.

  2. Degree of improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea severity [ Time Frame: Day 0 and 16 weeks ]
    Measured for each treatment arm as assessed by the treating investigator using the Rosacea Grading Scale.

  3. Degree of improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea [ Time Frame: Day 0, 4 weeks, 8 weeks, 16 weeks ]
    Measured for each treatment arm based on Subject's Global Assessment Scale.

  4. 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. [ Time Frame: Day 0, 4 weeks, 8 weeks, 16 weeks ]
    Compare between two treatment arms assessed using Subject's Comparative Face Assessment Scale.

  5. Subject satisfaction level [ Time Frame: Day 0, 4 weeks, 8 weeks, 16 weeks ]
    Compare each treatment arm using Subject Satisfaction Assessment

  6. Change in Dermatology Life Quality Index [ Time Frame: Day 0 and 16 weeks ]
    Post-final treatment as compared to baseline

  7. Spectrophotometer measurements [ Time Frame: Day 0 and 16 weeks ]
    Change in lesion skin color (mean a* value) post-final treatment as compared to baseline for each treatment arm.

  8. Subject discomfort (pain) [ Time Frame: Day 0, 4 weeks, 8 weeks ]
    Measured during each treatment using Mosby Pain Rating Scale for each treatment arm

  9. Adverse Events [ Time Frame: Day 0, 4 weeks, 8 weeks ]
    Incidence and severity of adverse device effects for each treatment arm during the study period



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268474


Locations
United States, Florida
Miami Dermatology & Laser Institute
Miami, Florida, United States, 33173
Sponsors and Collaborators
Cutera Inc.

Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT02268474     History of Changes
Other Study ID Numbers: C-14-EV04
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015

Keywords provided by Cutera Inc.:
532nm
Excel V
Cutera
Laser
Laser Light
PDL
595nm
Flash Lamp

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents