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Completed

NCT Number: NCT04202419

Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

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).

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Key information

Conditions

Pigmented Skin Lesion

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miami Dermatology and Laser Institute

Miami, Florida, 33173, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female
  • Age 21 to 70
  • Fitzpatrick Skin Type I to VI
  • 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
  • Provide signed informed consent to participate in the study
  • Adhere to study treatment and follow-up schedules
  • Willing to have hair removed from the intended treatment area prior to treatment and/or photography
  • 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
  • Adhere to post-treatment care instructions
  • Allow photography of treated areas and to release their use for scientific and/or promotional purposes

Exclusion criteria

  • Pregnant, planning to become pregnant, or breast feeding during the study
  • Allergy to lidocaine or similar medications
  • Excessively tanned skin in the intended treatment area
  • Open wound or infection in the intended treatment area
  • Tattoo(s) or permanent make-up in the intended treatment area
  • Skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy
  • Presence or history of melasma
  • Presence or history of skin cancer within the treatment area
  • History of keloid or hypertrophic scar formation
  • History of herpes simplex virus (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
  • Diagnosed coagulation disorder
  • Immunosuppression disorder
  • Presence of any medical condition that in the opinion of the Investigator could impair healing or outcome as a result of treatment
  • Use of systemic retinoid therapy (e.g. Accutane) during the past six (6) months
  • Use of topical retinoid therapy in the intended treatment area during the past two (2) weeks
  • Use of oral corticosteroid therapy during the past four (4) weeks
  • Prior treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past three (3) months
  • Prior injectable dermal fillers (e.g. collagen, hyaluronic acid) in the intended treatment area within the past 12 months
  • Prior injectable toxins (e.g. Botox) in the intended treatment area within the past three (3) months
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Pigmented Lesion Improvement by Blinded Evaluation

    Time frame: 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 outcomes

  1. Pigmentation Improvement at the 3-month Follow-up, by Blinded Evaluation

    Time frame: 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).

  2. Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS)

    Time frame: 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.

  3. Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS)

    Time frame: 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

  4. Subject Satisfaction With Treatment Results

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Candela Corporation

Industry

Collaborators

  • Miami Dermatology and Laser Institute

Registry information

Official study title

Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Treatment of Pigmented Lesions

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2019
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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