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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04807179
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : October 18, 2022
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

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.

Condition or disease Intervention/treatment Phase
Acne Scars Device: Experimental: RF Device Arm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Clinical Study To Evaluate The Efficacy And Safety Of An Alexandrite Laser Device For The Treatment Of Acne Scars
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: Alexandrite Laser
Single arm, self-controlled
Device: Experimental: RF Device Arm
Non-invasive radiofrequency Alexandrite laser




Primary Outcome Measures :
  1. Photographic Evaluation of Changes in Treatment Areas [ Time Frame: Baseline and 90 day follow up ]
    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 :
  1. Photographic Evaluation of Treatment Areas [ Time Frame: Baseline and 30 day follow up ]
    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.

  2. Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which [ Time Frame: Baseline and 30 day follow up ]
    Blind identification of pre-treatment images vs. 30 day follow up images performed by independent reviewers.

  3. Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which [ Time Frame: Baseline and 90 day follow up ]
    Blind identification of pre-treatment images vs. 90 day follow up images performed by independent reviewers.

  4. Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) [ Time Frame: Baseline and 30 day follow up ]
    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."

  5. Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) [ Time Frame: Baseline and 90 day follow up ]
    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."

  6. Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) [ Time Frame: Baseline and 30 day follow up ]
    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."

  7. Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) [ Time Frame: Baseline and 90 day follow up ]
    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."

  8. Subject satisfaction [ Time Frame: 30 day follow up ]
    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.

  9. Subject satisfaction [ Time Frame: 90 day follow up ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807179


Contacts
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Contact: Jamie Trimper 800-886-2966 jamie.trimper@cynosure.com

Locations
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United States, California
Wallace Skin and Body Institute Recruiting
Los Angeles, California, United States, 90056
Contact: Paul Wallace         
United States, New York
Laser & Skin Surgery Center of New York Active, not recruiting
New York, New York, United States, 10016
Sponsors and Collaborators
Cynosure, Inc.
Investigators
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Study Director: Jennifer Civiok Cynosure, Inc.
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Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT04807179    
Other Study ID Numbers: 7012-RGPL-2021
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases