Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions

Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Skin Resurfacing and Treatment of Pigmented Lesions

This study is intended to evaluate the efficacy and safety of a new diode fractional laser for skin resurfacing and treatment of pigmented lesions.

Study Overview

• Status: Completed
• Conditions: Pigmented Lesions; Skin Texture
• Intervention / Treatment: Device: Nonablative Fractional Diode Laser

Detailed Description

This study is a prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for skin resurfacing.

Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will receive up to 4 treatments to the face, and other off-face locations may be treated. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final treatment.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Marlborough, Massachusetts, United States, 01752
      • Candela Institute for Excellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or Female
2. Age 21 to 70
3. Fitzpatrick Skin Type I to V
4. Willingness to have test spots and up to three (3) skin resurfacing treatments on the face
5. Presence of pigmented lesions to be treated off the face must be rated at baseline as moderate or higher per Investigator or study staff
6. Provide signed informed consent to participate in the study
7. Adhere to study treatment and follow-up schedules
8. Willing to have hair removed from the intended treatment area prior to treatment and/or photography
9. Avoid sun exposure to all treated areas and use of sunscreen with sun protection factor (SPF) 30 or greater throughout the duration of the study
10. Adhere to post-treatment care instructions
11. Allow photography of treated areas and to release their use for scientific and/or promotional purposes

Exclusion Criteria:

1. Pregnant, planning to become pregnant, or breast feeding during the study
2. Allergy to lidocaine or similar medications
3. Excessively tanned skin in the intended treatment area
4. Open wound or infection in the intended treatment area
5. Tattoo(s) or permanent make-up in the intended treatment area
6. Skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy
7. Presence or history of melasma
8. Presence or history of skin cancer within the treatment area(s)
9. History of keloid or hypertrophic scar formation
10. History of herpes simplex virus (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
11. Diagnosed coagulation disorder
12. Immunosuppression
13. Presence of any medical condition that in the opinion of the Investigator could impair healing or outcome as a result of treatment
14. Use of systemic retinoid therapy (e.g. Accutane) during the past six (6) months
15. Use of topical retinoid therapy in the intended treatment area during the past two (2) weeks
16. Use of oral corticosteroid therapy during the past four (4) weeks
17. Prior skin resurfacing treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past six (6) months
18. Prior injectable dermal fillers in the intended treatment areas within the past twelve (12) months
19. Prior injectable toxins (Botox) in the treated areas within the past three (3) months
20. Subjects who in the opinion of the Investigator are unwilling or unable to adhere to the study requirements, or who are otherwise not a good candidate for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nonablative Fractional Diode Laser; Single Group - single arm study. Group was treated with Nonablative Fractional Diode Laser	Device: Nonablative Fractional Diode Laser; The FRAX 1940 is a fractional 1940 nm solid-state diode laser that delivers linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pigmented Lesion Improvement by Blinded Evaluation	The primary efficacy endpoint was defined as improvement in the clearance of pigmented lesions, as assessed by three (3) blinded evaluators comparing photographs taken at Baseline/Pre-treatment and at the 1-month follow-up (post final treatment)	1 month follow-up post treatment series, where treatment could last up to 10 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Number, severity and duration of adverse events following laser treatment.	From Day 0
Change in Global Assessment Improvement Scale (GAIS).	Improvement in clearance of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles) on the Global Assessment Improvement Scale (GAIS).	Baseline vs. 1 Month Follow-up (post final treatment)
Change in Global Assessment Improvement Scale (GAIS).	Improvement in clearance of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles) on the Global Assessment Improvement Scale (GAIS).	Baseline vs. 3 Month Follow-up (post final treatment)

Collaborators and Investigators

• Sponsor: Candela Corporation
• Investigators: Principal Investigator: Konika P Schallen, M.D., Candela Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): August 5, 2021

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FRX19004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No