Trial Outcomes & Findings for Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions (NCT NCT04203745)

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

26 participants

Primary outcome timeframe

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

Results posted on

2023-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Nonablative Fractional Diode Laser 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.
Overall Study STARTED	26
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Group n=36 treatment areas 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.
Age, Continuous	51.7 years STANDARD_DEVIATION 9.0 • n=93 Participants
Sex: Female, Male Female	15 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Race/Ethnicity, Customized Asian	11 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian (White)	15 Participants n=93 Participants
Region of Enrollment United States	26 participants n=93 Participants

PRIMARY outcome

Timeframe: 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).

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 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.
Pigmented Lesion Improvement by Blinded Evaluation	41 observations

Adverse Events

Single Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single Group n=26 participants at risk 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.
Skin and subcutaneous tissue disorders Rash	3.8% 1/26 • Number of events 1 • 12 weeks following last treatment, where treatment series could last up to 10 weeks.
Skin and subcutaneous tissue disorders Melasma	11.5% 3/26 • Number of events 3 • 12 weeks following last treatment, where treatment series could last up to 10 weeks.

Additional Information

Dr. Konika Patel Schallen

Candela Medical

Phone: 508-358-0357

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place