Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

Not Applicable

Completed

Conditions: Pigmented Skin Lesion

Interventions: Device: FRAX 1940 nm laser

Registration Number: NCT04202419

Lead Sponsor: Candela Corporation

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).

Detailed Description: Prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for treatment of pigmented lesions.

Up to 60 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to three (3) treatments in the following treatment areas: face, hands, arms, back, chest, or legs. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final study treatment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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
Use of oral corticosteroid therapy during the past four (4) weeks
Prior treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past three (3) months
Prior injectable dermal fillers (e.g. collagen, hyaluronic acid) in the intended treatment area within the past 12 months
Prior injectable toxins (e.g. Botox) in the intended treatment area within the past three (3) months
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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pigmented Lesion Improvement by Blinded Evaluation	1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline	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)

Secondary Outcome Measures

Name	Time	Method
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	The secondary endpoint was pigmentation improvement at the 3-month follow-up, as assessed by three (3) blinded evaluators comparing photographs taken at Baseline/Pre-treatment and at the 3-month follow-up (post final treatment). The treated area was considered a "success" if at least two of the three reviewers correctly identified the post-treatment photograph (i.e. left or right side).
Subject Satisfaction With Treatment Results	1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline	Subject satisfaction with treatment results completed at the 1-month follow-up using a 5 point scale coded as follows: -1=not satisfied, 0=little satisfied; 1=somewhat satisfied; 2=satisfied; and 3=very satisfied
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	For each reviewer assessment: If the post-treatment photograph was identified correctly, the reviewer's assessment on the textural scale was coded as follows: -1=worse, 0=no change; 1=improved; 2=much improved; and 3=very much improved. If not identified correctly, the scale was reversed (-1=improved, 0=no change, 1=worsened, 2=much worsened and 3=very much worsened). Results were based on the majority rule of the assessments by the three blinded reviewers; in other words, the mode of the three blinded reviewers' scores was used as the treated area clearance results, while the median was used if three different scores were reported.
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 assessments of treatment outcome were completed at the 1-month follow-up using the Global Assessment Improvement Scale (GAIS). The scale was coded as follows: -1=worse, 0=no change; 1=improved; 2=much improved; and 3=very much improved