A Single-Center Open-Label Study of 1064 nm Nd:YAG for Nonablative Skin Rejuvenation

• ClinicalTrials.gov Identifier: NCT03421691
• Recruitment Status: Unknown
• First Posted: February 5, 2018
• Last Update Posted: February 5, 2018
• Sponsor: Cutera Inc.
• Information provided by (Responsible Party): Cutera Inc.

Study Description

Brief Summary:

The purpose of this investigation is to evaluate the safety and efficacy of the Cutera excel V Laser Genesis procedure utilizing the 1064nm Nd:YAG laser for skin rejuvenation.

Condition or disease	Intervention/treatment	Phase
Skin Pigment; Photoaging	Device: excel V Laser	Not Applicable

Detailed Description:

This is a single-center prospective, open-label uncontrolled study in 15 male or female subjects, age 35 to 55 years who desire non-ablative laser treatment for facial photo-rejuvenation, specifically improvement of rhytides, lentigines, erythema, telangiectasia and skin texture. Subjects will receive up to 6 laser treatments spaced 2 to 4 weeks apart and complete two follow-up visits; one at 4 weeks and one at 12 weeks post-final treatment.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Single-Center Open-Label Study of 1064 nm Nd:YAG for Nonablative Skin Rejuvenation
• Actual Study Start Date: March 15, 2016
• Estimated Primary Completion Date: November 2018
• Estimated Study Completion Date: December 2018

Arms and Interventions

Arm	Intervention/treatment
Excel V laser; excel V Laser Genesis procedure utilizing 1064 nm Nd:YAG laser	Device: excel V Laser; excel V Laser Genesis procedure utilizing 1064 nm Nd:YAG laser

Outcome Measures

Primary Outcome Measures :

1. Degree of Improvement Rating #1 [ Time Frame: 4 week post-final treatment and 12 weeks post-final treatment ]
   Rate the degree of improvement from Baseline observed in the post-treatment photographs (4 weeks and 12 weeks) as assessed by independent blinded Reviewers using the Physician's Global Assessment of Improvement Scale (GAIS) GAIS: +4=Very Significant Improvement (> 75%),+3=Significant Improvement(51 - 75%), +2=Moderate Improvement(26 - 50%), +1=Mild Improvement(5 - 25%) and 0=No Change(<5%)
2. Degree of Improvement Rating #2 [ Time Frame: 4 week post-final treatment and 12 weeks post-final treatment ]
   Rate the degree of improvement from Baseline observed in the post-treatment photographs (4 weeks and 12 weeks) as assessed by the Investigator using the Physician's Global Assessment of Improvement Scale (GAIS) GAIS: +4=Very Significant Improvement (> 75%),+3=Significant Improvement(51 - 75%), +2=Moderate Improvement(26 - 50%), +1=Mild Improvement(5 - 25%) and 0=No Change(<5%)
3. Degree of Improvement Rating #3 [ Time Frame: 4 week post-final treatment and 12 weeks post-final treatment ]
   Rate the degree of improvement from Baseline observed in the post-treatment photographs (4 weeks and 12 weeks) as assessed by the Subject using the Physician's Global Assessment of Improvement Scale (GAIS) GAIS: +4=Very Significant Improvement (> 75%),+3=Significant Improvement(51 - 75%), +2=Moderate Improvement(26 - 50%), +1=Mild Improvement(5 - 25%) and 0=No Change(<5%)

Secondary Outcome Measures :

1. Effectiveness Assessment: Temporal Order [ Time Frame: 12 weeks post-final treatment ]
   Correct identification of the temporal order of each photograph pair (Baseline, 4 weeks post-treatment, 12 weeks post-treatment) as determined by independent blinded reviewers.

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Female or Male, 35 to 55 years of age (inclusive).
2. Fitzpatrick Skin Type I - IV (Appendix 4).
3. Desires non-invasive and non-ablative treatment of skin-aging or photo-rejuvenation of the skin.
4. Have signs of moderate skin aging, including presence of mild to moderate rhytides around eyes and upper lip, multiple lentigines, diffuse erythema or telangiectasia, and a score between 4 and 7 (inclusive) on the Fitzpatrick Wrinkle Classification Scale (Appendix 3).
5. Subject 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. Willing to have very limited sun exposure and use an approved sunscreen of SPF 30 or higher on the treatment area every day for the duration of the study, including the follow-up period.
8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
9. Agree to not undergo any other procedure(s) for skin rejuvenation during the study, including but not limited to chemical peel, laser and light based device treatment, and home-use device treatment.
10. Agree to not undergo any injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler during the study.

11. 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, and no plans to become pregnant or to father a child for the duration of the study.

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Exclusion Criteria:

1. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
2. Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
3. Prior injection to the face of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation, as applicable.
4. Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
5. Use of topical medications on the face, such as antibiotics, benzoyl peroxide, retinoids (isotretinoin), corticosteroids, hydroquinone, or products containing dihydroxyacetone or alpha-hydroxy with concentration > 8%, within 1 month of participation.
6. History of malignant tumors in the target area.
7. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
8. Pregnant and/or breastfeeding.
9. Having an infection, dermatitis or a rash in the treatment area.
10. Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
11. Suffering from coagulation disorders, or taking prescription anticoagulation medication which might make study participation unsafe according to Investigator's discretion.
12. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
13. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
14. History of vitiligo, eczema, or psoriasis.
15. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
16. History of seizure disorders due to light.
17. Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
18. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
19. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
20. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
21. Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
22. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
23. Current smoker or history of smoking within 6 months of study participation.

24. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

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Contacts and Locations

Contacts

Contact: Michaela Bell; 415-657-5722; mbell@cutera.com

Contact: Ginger Pocock; 415-657-5702; gpocock@cutera.com

Locations

United States, New York

Skin Laser and Surgery Specialists of NY and NJ; Recruiting

New York, New York, United States, 10022

Contact: Bradley Bloom, MD drbloom@skinandlasers.com

Contact: Diana Aranzazu dianaa@skinandlasers.com

Principal Investigator: Bradley Bloom, MD

Sponsors and Collaborators

Cutera Inc.

More Information

• Responsible Party: Cutera Inc.
• ClinicalTrials.gov Identifier: NCT03421691
• Other Study ID Numbers: C-16-EV10
• First Posted: February 5, 2018
• Last Update Posted: February 5, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Pigmentation Disorders; Skin Diseases; Pathologic Processes