NCT05362929 · Albert Einstein College of Medicine
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
What this study is about
The investigators aim to investigate the effectiveness and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.
View original scientific description
The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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
Where
- Elmsford, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2025 · Source of record for eligibility and locations