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

Recruiting now · Not applicable

Conditions studied: Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation, Laser-Induced Hyperpigmentation

In brief

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

Key facts

Study ID

NCT05362929

Run by

Albert Einstein College of Medicine

People needed

50

Starts

2023-10-11

Expected to finish

2029-07-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Subject has no health contraindications to receiving local lidocaine and epinephrine injections, including but not limited to any form of heart disease or arrhythmia, untreated or uncontrolled severe hypertension, uncontrolled hyperthyroidism, uncontrolled diabetes, pheochromocytoma, cocaine use
• 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 TCA, MAO, or beta-blockers
• 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

Where it is running

• 555 Taxter Road — Elmsford, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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