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

NCT04807179 | Active Not Recruiting FDA Device

• 1 other identifier: 7012-RGPL-2021
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Scars

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Photographic Evaluation of Treatment Areas

  Baseline and 30 day follow up

• Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which

  Baseline and 30 day follow up

• Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which

  Baseline and 90 day follow up

• Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)

  Baseline and 30 day follow up

• Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)

  Baseline and 90 day follow up

Study Arms (1)

Alexandrite Laser

EXPERIMENTAL

Single arm, self-controlled

Device: Experimental: RF Device Arm

Interventions

Experimental: RF Device Arm DEVICE

Non-invasive radiofrequency Alexandrite laser

Alexandrite Laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (2)

Wallace Skin and Body Institute

Los Angeles, California, 90056, United States

Location

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Study Officials

• Jennifer Civiok

  Cynosure, Inc.

  STUDY DIRECTOR

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: March 11, 2021
• First Posted: March 19, 2021
• Study Start: March 8, 2021
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)