Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Montefiore Medical Center · with Sciton · NCT05362929
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 50
- US sites recruiting
- 1
- Study start
- October 11, 2023
- Record last updated
- October 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.
Being studied: Sciton Halo
Conditions: Acne Scars - Mixed Atrophic and Hypertrophic; Hyperpigmentation; Laser-Induced Hyperpigmentation
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Recruiting US locations
555 Taxter Road
Elmsford, NY 10523
Site contact: Gabriela Gjini · 914-457-4130 · ggjini@montefiore.org
Study contacts (from the official record)
- Ryan Chan, BA · 631-553-2203 · ryachan@montefiore.org
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