Clinical trial NCT04807179: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acne Scars
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Photographic Evaluation of Changes in Treatment Areas
timeFrame: Baseline and 90 day follow up
Secondary outcomes:
measure: Photographic Evaluation of Treatment Areas
timeFrame: Baseline and 30 day follow up
measure: Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which
timeFrame: Baseline and 30 day follow up
measure: Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which
timeFrame: Baseline and 90 day follow up
measure: Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)
timeFrame: Baseline and 30 day follow up
measure: Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)
timeFrame: Baseline and 90 day follow up
measure: Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)
timeFrame: Baseline and 30 day follow up
measure: Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)
timeFrame: Baseline and 90 day follow up
measure: Subject satisfaction
timeFrame: 30 day follow up
measure: Subject satisfaction
timeFrame: 90 day follow up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Wallace Skin and Body Institute
state: California
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Jennifer Civiok
role: STUDY_DIRECTOR
References: