Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patient… (NCT05362929) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
United States46 participantsStarted 2023-10-11
Plain-language summary
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
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Change from baseline acne scar severity
Timeframe: month 3
2
Change from baseline acne scar severity
Timeframe: month 5
3
Change from baseline acne scar severity
Timeframe: month 8
4
Baseline Patient Satisfaction
Timeframe: month 0 (patient consultation visit )
5
Patient Satisfaction
Timeframe: throughout study completion, an average of 8 months