NCT04203745

Brief Summary

This study is intended to evaluate the efficacy and safety of a new diode fractional laser for skin resurfacing and treatment of pigmented lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2021

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

December 10, 2019

Results QC Date

April 10, 2023

Last Update Submit

July 13, 2023

Conditions

Skin TexturePigmented Lesions

Outcome Measures

Primary Outcomes (1)

  • 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 from baseline

Study Arms (1)

Nonablative Fractional Diode Laser

EXPERIMENTAL

Single Group - single arm study. Group was treated with Nonablative Fractional Diode Laser

Device: Nonablative Fractional Diode Laser

Interventions

Nonablative Fractional Diode LaserDEVICE

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.

Nonablative Fractional Diode Laser

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female
  • Age 21 to 70
  • Fitzpatrick Skin Type I to V
  • Willingness to have test spots and up to three (3) skin resurfacing treatments on the face
  • Presence of pigmented lesions to be treated off the face must be 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

You may not qualify if:

  • 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(s)
  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Candela Institute for Excellence

Marlborough, Massachusetts, 01752, United States

Location

Results Point of Contact

Title
Dr. Konika Patel Schallen
Organization
Candela Medical
konikap@candelamedical.com
508-358-0357

Study Officials

  • Konika P Schallen, M.D.

    Candela Corporation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 18, 2019

Study Start

September 18, 2019

Primary Completion

April 30, 2021

Study Completion

August 5, 2021

Last Updated

August 1, 2023

Results First Posted

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)