Trial Outcomes & Findings for Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions (NCT NCT04202419)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

1 month follow-up post treatment series, where treatment could last up to 10 weeks after baseline

Results posted on

2023-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Group n=30 treatment areas 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.
Age, Continuous	56.1 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized White	29 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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)

Outcome measures

Outcome measures
Measure	Nonablative Fractional Diode Laser n=45 Observations 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.
Pigmented Lesion Improvement by Blinded Evaluation	41 Observations

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	Nonablative Fractional Diode Laser n=42 observations 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.
Pigmentation Improvement at the 3-month Follow-up, by Blinded Evaluation	35 observations

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nonablative Fractional Diode Laser n=45 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.
Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS) No change (stable)	16 Participants
Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS) Improved	28 Participants
Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS) Worse	1 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Nonablative Fractional Diode Laser n=45 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.
Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS) Worse	1 Participants
Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS) No Change	3 Participants
Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS) Improved	17 Participants
Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS) Much Improved	10 Participants
Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS) Very Much Improved	14 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Nonablative Fractional Diode Laser n=44 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.
Subject Satisfaction With Treatment Results Not Satisfied	1 Participants
Subject Satisfaction With Treatment Results Little Satisfied	2 Participants
Subject Satisfaction With Treatment Results Somewhat Satisfied	14 Participants
Subject Satisfaction With Treatment Results Satisfied	12 Participants
Subject Satisfaction With Treatment Results Very Satisfied	15 Participants

Adverse Events

Nonablative Fractional Diode Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jill Waibel

Miami Dermatology and Laser Institute

Phone: (305) 615-2393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60