Clinical Study to Evaluate Alexandrite Laser for the Treatment of Acne Scars

Prospective Clinical Study To Evaluate The Efficacy And Safety Of An Alexandrite Laser Device For The Treatment Of Acne Scars

The intended use of the Alexandrite laser device used in this study is to assess the efficacy and safety of the Alexandrite laser device for the treatment of acne scars on skin types V and VI.

Study Overview

• Status: Active, not recruiting
• Conditions: Acne Scars
• Intervention / Treatment: Device: Experimental: RF Device Arm

Detailed Description

Subjects are to be enrolled in this clinical study if they are 18-65 years old. A maximum of 25 subjects will be enrolled at 1 study center. Subjects will receive up to 6 treatments (minimum of 4 treatment visits with an optional 5th and 6th treatment) on the face. Subjects will return for follow up visits at 30 and 90 days post last treatment. All subjects will receive a phone call 1 week after each treatment.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90056
      • Wallace Skin and Body Institute
  • New York
    • New York, New York, United States, 10016
      • Laser & Skin Surgery Center of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A healthy male or female 18 - 65 years of age.
• Has acne scars on the face (left, right, or front) and willing to undergo treatments with the study device.
• Is a skin type V or VI.
• Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
• Understands and accepts the obligation and is logistically able to be present for all visits.
• Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria:

• Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
• The subject is hypersensitive to light in the near infrared wavelength region.
• The subject takes medication which is known to increase sensitivity to sunlight.
• The subject has seizure disorders triggered by light.
• The subject takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
• The subject has an active localized or systemic infection, or an open wound in area being treated.
• The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated.
• The subject has common acquired nevi that are predisposed to the development of malignant melanoma.
• The subject has herpes simplex in the area being treated.
• The subject is receiving or has received gold therapy.
• The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study.
• The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Cautionary Criteria:

• The subject has had unprotected sun exposure within four weeks of treatment, including the use of tanning beds or tanning products, such as creams, lotions and sprays.
• The subject has a history of immunosuppression/immune deficiency or an auto-immune disorder.
• The subject has a coagulation disorder or currently using anticoagulation medication, including heavy use of aspirin.
• The subject is taking medications that alter the wound-healing response or evidence of compromised wound healing.
• The subject is known to have a history of keloid formation.
• The subject has a history of skin cancer or suspicious lesions in the treatment area.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alexandrite Laser; Single arm, self-controlled	Device: Experimental: RF Device Arm; Non-invasive radiofrequency Alexandrite laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photographic Evaluation of Changes in Treatment Areas	Photographic evaluation with ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading comparing pre-treatment images to the 90 day follow up images performed by independent reviewers. This scale gives higher scores based on the number of scars, with the description of the scars determining the weighting factor. The scale ranges from 0 to 540, with a lower score meaning less severe scarring.	Baseline and 90 day follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photographic Evaluation of Treatment Areas	Photographic evaluation with ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading comparing pre-treatment images to the 30 day follow up images performed by independent reviewers. This scale gives higher scores based on the number of scars, with the description of the scars determining the weighting factor. The scale ranges from 0 to 540, with a lower score meaning less severe scarring.	Baseline and 30 day follow up
Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which	Blind identification of pre-treatment images vs. 30 day follow up images performed by independent reviewers.	Baseline and 30 day follow up
Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which	Blind identification of pre-treatment images vs. 90 day follow up images performed by independent reviewers.	Baseline and 90 day follow up
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)	Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 30 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."	Baseline and 30 day follow up
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)	Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 90 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."	Baseline and 90 day follow up
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)	Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) at the 30 follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."	Baseline and 30 day follow up
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)	Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) at the 90 follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."	Baseline and 90 day follow up
Subject satisfaction	Subject satisfaction rates at the 30 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied.	30 day follow up
Subject satisfaction	Subject satisfaction rates at the 90 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied.	90 day follow up

Collaborators and Investigators

• Sponsor: Cynosure, Inc.
• Investigators: Study Director: Jennifer Civiok, Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Estimated): August 2, 2024
• Study Completion (Estimated): August 2, 2024

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 7012-RGPL-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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