Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Miami Dermatology and Laser Institute | OTHER |
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | Experimental | Single Arm: All subjects will undergo treatment of pigmented lesions with a 1940 nm diode laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jill S Waibel, M.D | Miami Dermatology and Laser Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Dermatology and Laser Institute | Miami | Florida | 33173 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nonablative Fractional Diode Laser | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Thirty subjects with 30 areas were enrolled in study FRX19005
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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). | Posted | Count of Units | Observations | 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline | Observations | Observations |
|
12 weeks following last treatment, where treatment series could last up to 10 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nonablative Fractional Diode Laser | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jill Waibel | Miami Dermatology and Laser Institute | (305) 615-2393 | info@miamidermlaser.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2019 | Jul 13, 2023 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) | 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. | 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) | 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 | 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline |
| 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 | 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline |
| treatment areas |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
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. |
|
|
| 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). | 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). | Posted | Count of Units | observations | 3-months post final treatment, where treatment series could last up to 10 weeks after baseline | observations | 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. | 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. | Posted | Count of Participants | Participants | 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
Not provided
| Much Improved |
|
| Very Much Improved |
|
| Satisfied |
|
| Very Satisfied |
|