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

Pigmented Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203745
• Other study ID #: FRX19004
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: August 5, 2021

Study information

• Verified date: July 2023
• Source: Candela Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 5, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pigmented Lesions

Intervention

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.

Locations

Country	Name	City	State
United States	Candela Institute for Excellence	Marlborough	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Candela Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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