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

Primary Purpose

Acne Scars

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: RF Device Arm
Sponsored by
Cynosure, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scars

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wallace Skin and Body InstituteRecruiting
  • Laser & Skin Surgery Center of New York

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alexandrite Laser

Arm Description

Single arm, self-controlled

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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."
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."
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."
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."
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.
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.

Full Information

First Posted
March 11, 2021
Last Updated
June 14, 2023
Sponsor
Cynosure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04807179
Brief Title
Clinical Study to Evaluate Alexandrite Laser for the Treatment of Acne Scars
Official Title
Prospective Clinical Study To Evaluate The Efficacy And Safety Of An Alexandrite Laser Device For The Treatment Of Acne Scars
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cynosure, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Alexandrite Laser
Arm Type
Experimental
Arm Description
Single arm, self-controlled
Intervention Type
Device
Intervention Name(s)
Experimental: RF Device Arm
Intervention Description
Non-invasive radiofrequency Alexandrite laser
Primary Outcome Measure Information:
Title
Photographic Evaluation of Changes in Treatment Areas
Description
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.
Time Frame
Baseline and 90 day follow up
Secondary Outcome Measure Information:
Title
Photographic Evaluation of Treatment Areas
Description
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.
Time Frame
Baseline and 30 day follow up
Title
Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which
Description
Blind identification of pre-treatment images vs. 30 day follow up images performed by independent reviewers.
Time Frame
Baseline and 30 day follow up
Title
Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which
Description
Blind identification of pre-treatment images vs. 90 day follow up images performed by independent reviewers.
Time Frame
Baseline and 90 day follow up
Title
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)
Description
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."
Time Frame
Baseline and 30 day follow up
Title
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)
Description
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."
Time Frame
Baseline and 90 day follow up
Title
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)
Description
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."
Time Frame
Baseline and 30 day follow up
Title
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)
Description
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."
Time Frame
Baseline and 90 day follow up
Title
Subject satisfaction
Description
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.
Time Frame
30 day follow up
Title
Subject satisfaction
Description
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.
Time Frame
90 day follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Trimper
Phone
800-886-2966
Email
jamie.trimper@cynosure.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Civiok
Organizational Affiliation
Cynosure, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Wallace Skin and Body Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Wallace
Facility Name
Laser & Skin Surgery Center of New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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