Pigmented Lesions, Skin Texture
Conditions
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.
Interventions
DEVICENonablative 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.
Sponsors
Candela Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pigmented Lesion Improvement by Blinded Evaluation | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Group Single Group - single arm study
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. | 26 |
| Single Group Single Group - single arm study
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. | 36 |
| Total | 62 |
Baseline characteristics
| Characteristic | Single Group |
|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 9 |
| Race/Ethnicity, Customized Asian | 11 Participants |
| Race/Ethnicity, Customized Caucasian (White) | 15 Participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 4 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
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)
Time frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks from baseline
Population: Data from FRX19004 study was combined with FRX19005 study (NCT04202419) for ad-hoc primary efficacy analysis via blinded evaluation. Both trials assessed the 'treatment of pigmented lesions' and are directly comparable due to equivalence of patient populations and efficacy endpoints, therefore, the exact same analyses were performed. The treated area was considered a success if at least 2 of the 3 reviewers correctly identified the post-treatment photograph (i.e. left or right side).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Nonablative Fractional Diode Laser | Pigmented Lesion Improvement by Blinded Evaluation | 41 observations |