Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

NCT04202419 | Completed Results FDA Device

• 1 other identifier: FRX19005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to evaluate the safety and efficacy of a fractional diode laser for treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles).

Conditions

Pigmented Skin Lesion

Outcome Measures

Primary Outcomes (1)

• 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 after baseline

Secondary Outcomes (4)

• Pigmentation Improvement at the 3-month Follow-up, by Blinded Evaluation

  3-months post final treatment, where treatment series could last up to 10 weeks after baseline

• Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS)

  1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline

• Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS)

  1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline

• Subject Satisfaction With Treatment Results

  1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline

Study Arms (1)

Single Group

EXPERIMENTAL

Single Arm: All subjects will undergo treatment of pigmented lesions with a 1940 nm diode laser

Device: FRAX 1940 nm laser

Interventions

FRAX 1940 nm laser DEVICE

A fractional 1940 nm solid-state diode laser will deliver linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin, in order to treat pigmented skin lesions.

Single Group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• Age 21 to 70
• Fitzpatrick Skin Type I to VI
• Willingness to have test spots and up to three (3) treatments for pigmented lesions on or off the face which are rated at baseline as moderate or higher per Investigator or study staff
• Provide signed informed consent to participate in the study
• Adhere to study treatment and follow-up schedules
• Willing to have hair removed from the intended treatment area prior to treatment and/or photography
• 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
• Adhere to post-treatment care instructions
• Allow photography of treated areas and to release their use for scientific and/or promotional purposes

You may not qualify if:

• Pregnant, planning to become pregnant, or breast feeding during the study
• Allergy to lidocaine or similar medications
• Excessively tanned skin in the intended treatment area
• Open wound or infection in the intended treatment area
• Tattoo(s) or permanent make-up in the intended treatment area
• Skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy
• Presence or history of melasma
• Presence or history of skin cancer within the treatment area
• History of keloid or hypertrophic scar formation
• History of herpes simplex virus (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
• Diagnosed coagulation disorder
• Immunosuppression disorder
• Presence of any medical condition that in the opinion of the Investigator could impair healing or outcome as a result of treatment
• Use of systemic retinoid therapy (e.g. Accutane) during the past six (6) months
• Use of topical retinoid therapy in the intended treatment area during the past two (2) weeks

Sponsors & Collaborators

• Candela Corporation: lead
• Miami Dermatology and Laser Institute: collaborator

Study Sites (1)

Miami Dermatology and Laser Institute

Miami, Florida, 33173, United States

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Dr. Jill Waibel
• Organization: Miami Dermatology and Laser Institute

info@miamidermlaser.com

(305) 615-2393

Study Officials

• Jill S Waibel, M.D

  Miami Dermatology and Laser Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 17, 2019
• Study Start: January 9, 2020
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: August 7, 2023
• Results First Posted: August 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)