Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Skin Resurfacing and Treatment of Pigmented Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Candela Corporation
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Pigmented Lesion Improvement by Blinded Evaluation
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or Female
- •Age 21 to 70
- •Fitzpatrick Skin Type I to V
- •Willingness to have test spots and up to three (3) skin resurfacing treatments on the face
- •Presence of pigmented lesions to be treated off the face must be 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(s)
- •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
- •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 skin resurfacing treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past six (6) months
- •Prior injectable dermal fillers in the intended treatment areas within the past twelve (12) months
- •Prior injectable toxins (Botox) in the treated areas 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
Outcomes
Primary Outcomes
Pigmented Lesion Improvement by Blinded Evaluation
Time Frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks from 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 Outcomes
No secondary outcomes reported