A Novel Neurocosmetic Postprocedure Cream for Optimal Recovery and Tolerability From Energy-Based Devices.
Аннотация
OBJECTIVES
A neurocosmetic post-procedure cream (NPPC) was developed as a semi-breathable topical to provide relief and recovery following energy-based device treatments. The NPPC was investigated following hybrid fractional and fractional ablative laser resurfacing to assess tolerability, safety, and patient compliance and retention, as well as compare against a conventional post-procedure topical routine.
METHODS
Two randomized, double-blinded, split-face, controlled, procedure-pairing studies were conducted with healthy females aged 35-65 years with Fitzpatrick Skin Types I-III and moderate to severe photodamage. Subjects were randomized to apply the NPPC and a comparator moisturizer (CM) or comparator anhydrous formulation (CAF) three times daily for 7 days post-hybrid fractional laser (HFL) or 14 days post-fractional ablative CO2 laser (FACL), respectively. Tolerability evaluations, questionnaires, and clinical photography were conducted at baseline and post-baseline timepoints.
RESULTS
Sixteen and twenty-two healthy female subjects completed the HFL and FACL studies, respectively. The NPPC was effective at improving erythema, edema, dryness, burning, itching, stinging, and discomfort as evidenced by tolerability evaluations, clinical photography, and questionnaires. There were no significant adverse events. Day 1 post-FACL treatment, 91% of subjects favorably agreed "the product calmed my skin." Patient relief and recovery were achieved with the NPPC. Across the two studies, the NPPC performed similarly or better than the conventional postprocedure topical routine investigated. The studies are limited to a small sample size, and the lack of a vehicle-only or untreated control arm is unethical.
CONCLUSIONS
An NPPC developed to soothe skin following energy-based device procedures demonstrated patient tolerability, safety, and improved healing time following hybrid and fractional ablative laser treatments. Patients indicated favorable responses to the treatments, and there was high agreement that they would return for a second treatment, denoting patient retention. The NPPC achieved comparable outcomes versus the conventional postprocedure topical routine in both HFL and FACL studies.
CLINICAL TRIAL REGISTRATION: 1. HFL Study: ClinicalTrials.gov ID: NCT06436261 https://clinicaltrials.gov/study/NCT06436261?term=NCT06436261&rank=1 2. FACL Study: ClinicalTrials.gov ID: NCT06366503 https://www.
CLINICALTRIALS: gov/study/NCT06366503?term=NCT06366503&rank=1 ClinicalTrials.gov registration was completed after study completion for journal publication purposes.
Предметные рубрики MeSH
Подготовка и перевод публикации
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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