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Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

Primary Purpose

Pigmented Skin Lesion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FRAX 1940 nm laser
Sponsored by
Candela Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pigmented Skin Lesion

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Miami Dermatology and Laser Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Group

Arm Description

Single Arm: All subjects will undergo treatment of pigmented lesions with a 1940 nm diode laser

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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.
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
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

Full Information

First Posted
December 16, 2019
Last Updated
July 13, 2023
Sponsor
Candela Corporation
Collaborators
Miami Dermatology and Laser Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04202419
Brief Title
Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions
Official Title
Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Treatment of Pigmented Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
April 26, 2021 (Actual)
Study Completion Date
April 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Candela Corporation
Collaborators
Miami Dermatology and Laser Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pigmented Skin Lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Group
Arm Type
Experimental
Arm Description
Single Arm: All subjects will undergo treatment of pigmented lesions with a 1940 nm diode laser
Intervention Type
Device
Intervention Name(s)
FRAX 1940 nm laser
Intervention Description
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 Outcome Measure Information:
Title
Pigmented Lesion Improvement by Blinded Evaluation
Description
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
Secondary Outcome Measure Information:
Title
Pigmentation Improvement at the 3-month Follow-up, by Blinded Evaluation
Description
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
Title
Blinded Assessment of Textural Improvement Using a 5-point Global Aesthetic Improvement Scale (GAIS)
Description
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
Title
Subject Assessment of Improvement Using a 5-point Global, Aesthetic Improvement Scale (GAIS)
Description
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
Title
Subject Satisfaction With Treatment Results
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill S Waibel, M.D
Organizational Affiliation
Miami Dermatology and Laser Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Dermatology and Laser Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

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