Status:
RECRUITING
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Lead Sponsor:
Albert Einstein College of Medicine
Conditions:
Acne Scars - Mixed Atrophic and Hypertrophic
Hyperpigmentation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.
Detailed Description
Acne is chronic inflammatory condition involving the pilosebaceous unit. One of the most common complications of acne is scarring, which occurs as a result of dermal damage during the healing process ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05362929
Start Date
October 11 2023
End Date
September 1 2026
Last Update
May 22 2025
Active Locations (1)
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1
555 Taxter Road
Elmsford, New York, United States, 10523