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Active, not recruitingNCT04807179Updated May 7, 2024

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

An interventional study of Experimental: RF Device Arm in Acne Scars, sponsored by Cynosure, Inc.. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by Cynosure, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acne Scars

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Alexandrite Laser

    Single arm, self-controlled

    Device: Experimental: RF Device Arm

Interventions

  • DeviceExperimental: RF Device Arm

    Non-invasive radiofrequency Alexandrite laser

05

What researchers measure

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.

    Time frame: Baseline and 90 day follow up

Secondary outcomes

  1. 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.

    Time frame: Baseline and 30 day follow up

  2. 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.

    Time frame: Baseline and 30 day follow up

  3. 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.

    Time frame: Baseline and 90 day follow up

  4. 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."

    Time frame: Baseline and 30 day follow up

  5. 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."

    Time frame: Baseline and 90 day follow up

  6. 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."

    Time frame: Baseline and 30 day follow up

  7. 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."

    Time frame: Baseline and 90 day follow up

  8. 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.

    Time frame: 30 day follow up

  9. 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.

    Time frame: 90 day follow up

06

Study locations

2 sites
  • Wallace Skin and Body Institute
    Los Angeles, California 90056, United States
  • Laser & Skin Surgery Center of New York
    New York, New York 10016, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04807179
Lead sponsor
Cynosure, Inc.
Responsible party
Sponsor
First posted
Mar 19, 2021
Start date
Mar 8, 2021
Primary completion
Aug 2, 2024 (estimated)
Completion
Aug 2, 2024 (estimated)
Last update
May 7, 2024

Study contacts

Jennifer Civiok
study director · Cynosure, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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