RecruitingNot ApplicableNCT05362929

Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color

Sponsor

Albert Einstein College of Medicine

Enrollment

46 participants

Start Date

Oct 11, 2023

Study Type

INTERVENTIONAL

Conditions

The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.

Min Age: 18 Years

Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for acne scarring
Subject must voluntarily sign and date an IRB approved informed consent form
Subjects with diagnosis of acne scarring recorded over the past 6 months
Able to read, understand and voluntarily provide written informed consent.
Subject is determined to be healthy, non-smoker
Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

Subjects does not have the capacity to consent to the study
subject underwent any acne scar treatments in the past 6 months prior to enrollment in the study
Subject has active papulopustular or cystic acne within the past 6 months.
Any history of keloidal scarring.
Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months.
History or current use of the following prescription medications:
Immunosuppressive medications/biologics, 6 months prior to and during the study
Accutane or other systemic retinoids within the past twelve months
Smoking or vaping in the past 12 months.
History of photosensitivity and/or connective tissue disease
History of hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders.
History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism.
History of ongoing pregnancy, active breastfeeding, cancer, and epilepsy