Using a hybrid laser to treat acne scars in people with darker skin
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
NA · Albert Einstein College of Medicine · NCT05362929
This study is testing a new type of laser treatment for acne scars to see if it works well and is safe for people with darker skin.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Albert Einstein College of Medicine (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Elmsford, New York) |
| Trial ID | NCT05362929 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and tolerability of a hybrid non-ablative and ablative laser treatment for acne scars specifically in individuals with skin of color. Acne scarring can significantly affect quality of life and mental health, and traditional treatments often have limitations for darker skin types. The hybrid laser aims to minimize risks such as hyperpigmentation while promoting collagen production to improve scar appearance. Participants will undergo treatment and be monitored for outcomes and side effects.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older with a diagnosis of acne scarring who have not undergone any treatments in the past six months.
Not a fit: Patients with active acne, keloidal scarring, or those who have had recent acne scar treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for individuals with darker skin tones suffering from acne scars.
How similar studies have performed: While laser treatments for acne scars have been explored, this specific hybrid approach for skin of color is relatively novel and may offer new insights into effective treatment options.
Eligibility criteria
Show full inclusion / exclusion 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. * 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 this trial is running
Elmsford, New York
- 555 Taxter Road — Elmsford, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Kseniya Kobets, MD — Montefiore Medical Center
- Study coordinator: Anika Jallorina, BS
- Email: ajallorina@montefiore.org
- Phone: 618-704-8716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation, Laser-Induced Hyperpigmentation, skin of color, fitzpatrick skin type III, fitzpatrick skin type IV, fitzpatrick skin type V, acne scarring