Pigmented Skin Lesion
Conditions
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.
Interventions
DEVICEFRAX 1940 nm laser
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.
Sponsors
Miami Dermatology and Laser Institute
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 VI 4. 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 5. Provide signed informed consent to participate in the study 6. Adhere to study treatment and follow-up schedules 7. Willing to have hair removed from the intended treatment area prior to treatment and/or photography 8. 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 9. Adhere to post-treatment care instructions 10. 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 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 disorder 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 treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past three (3) months 18. Prior injectable dermal fillers (e.g. collagen, hyaluronic acid) in the intended treatment area within the past 12 months 19. Prior injectable toxins (e.g. Botox) in the intended treatment area 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Group Single Arm: All subjects will undergo treatment of pigmented lesions with a 1940 nm diode laser
FRAX 1940 nm laser: 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. | 30 |
| Single Group Single Arm: All subjects will undergo treatment of pigmented lesions with a 1940 nm diode laser
FRAX 1940 nm laser: 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Single Group |
|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized White | 29 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
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 after baseline
Population: Data from FRX19005 study was combined with FRX19004 study (NCT04203745) 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 |
Secondary
Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS)
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.
Time frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Population: Data from FRX19005 study was combined with FRX19004 study (NCT04203745) for ad-hoc 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nonablative Fractional Diode Laser | Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS) | Worse | 1 Participants |
| Nonablative Fractional Diode Laser | Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS) | No change (stable) | 16 Participants |
| Nonablative Fractional Diode Laser | Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS) | Improved | 28 Participants |
Secondary
Pigmentation Improvement at the 3-month Follow-up, by Blinded Evaluation
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).
Time frame: 3-months post final treatment, where treatment series could last up to 10 weeks after baseline
Population: Data from FRX19004 study was combined with FRX19005 study (NCT04202419) for ad-hoc primary efficacy analysis via blinded evaluation. 42 slides containing 1 pair of photos (taken pre-treatment and 3-months post-treatment) were presented to three blinded evaluators. 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 | Pigmentation Improvement at the 3-month Follow-up, by Blinded Evaluation | 35 observations |
Secondary
Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS)
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
Time frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Population: Data from FRX19005 study was combined with FRX19004 study (NCT04203745) for ad-hoc 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nonablative Fractional Diode Laser | Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS) | Worse | 1 Participants |
| Nonablative Fractional Diode Laser | Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS) | No Change | 3 Participants |
| Nonablative Fractional Diode Laser | Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS) | Improved | 17 Participants |
| Nonablative Fractional Diode Laser | Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS) | Much Improved | 10 Participants |
| Nonablative Fractional Diode Laser | Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS) | Very Much Improved | 14 Participants |
Secondary
Subject Satisfaction With Treatment Results
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
Time frame: 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline
Population: Data from FRX19005 study was combined with FRX19004 study (NCT04203745) for ad-hoc 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nonablative Fractional Diode Laser | Subject Satisfaction With Treatment Results | Not Satisfied | 1 Participants |
| Nonablative Fractional Diode Laser | Subject Satisfaction With Treatment Results | Little Satisfied | 2 Participants |
| Nonablative Fractional Diode Laser | Subject Satisfaction With Treatment Results | Somewhat Satisfied | 14 Participants |
| Nonablative Fractional Diode Laser | Subject Satisfaction With Treatment Results | Satisfied | 12 Participants |
| Nonablative Fractional Diode Laser | Subject Satisfaction With Treatment Results | Very Satisfied | 15 Participants |