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1.
J Clin Aesthet Dermatol ; 16(10): 31-38, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37915337

RESUMO

Objective: The objective of this study is three-fold. Firstly, to evaluate an enhanced vitamin C serum (eVCS) and its' combination with a retinol-bakuchiol serum (RBS) on pigmentation in vitro. Secondly, to evaluate the effect of the eVCS on skin function ex vivo. Lastly, to evaluate eVCS and RSB in the treatment of facial hyperpigmentation and overall photodamage across a range of opposing environments. Methods: MelanoDerm™ tissues were topically treated with the eVCS, and a eVCS and RSB blend for 14 days, and then a melanin assay was performed. Surgical waste facial skin explants were incubated with the eVCS or control for five days and then fixed and stained for skin physiology and structure. A 12-week, IRB approved, study on female subjects (n=29, aged 35 to 65) with moderate global facial hyperpigmentation and overall photodamage was completed. Clinical assessment, tolerability measurements, and subject-assessments were performed baseline at Weeks 6, 8, and 12. Investigator Global Aesthetic Improvement Score was completed at Week 12. Results: The eVCS-treated facial skin explants achieved a significant 145 percent collagen increase compared to control. The eVCS-RSB combination proved synergistic in reducing melanin compared to the eVCS alone. The eVCS-RSB combination demonstrated significant clinical improvement at all timepoints and was well tolerated. Subject responses were favorable and GAIS score of 3.0 was achieved at Week 12, indicating an improvement. Limitations: Limitations include lack of placebo or vehicle control. Conclusion: The product pairing, eVCS and RSB, offers patients an efficacious and well-tolerated treatment to target pigmentation and photodamage. Clinical Trial: This study, Pro00050557, was approved by Advarra IRB (Columbia, Maryland) and submitted to ClinicalTrials.gov #: NCT05423873.

2.
Dermatol Surg ; 45(12): 1558-1566, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-30829754

RESUMO

BACKGROUND/OBJECTIVES: This trial evaluated the effectiveness and safety of Bellafill for full-face acne scar treatment. PATIENTS AND METHODS: In this open-label, nonrandomized, multicenter pilot study investigating the use of polymethylmethacrylate for full-face atrophic acne scar correction, 42 adult subjects with a mean age of 43 years were treated and assessed for safety and effectiveness at Months 4 and 7. There were no hypersensitivity reactions to pretreatment skin testing or during scar treatments. RESULTS: At 4 and 7 months after initial treatment, 92% and 95% of subjects, respectively, were responders with ≥1-point improvement on the 5-point Acne Scar Assessment Scale. Subjects reported very high levels of improvement on the Global Aesthetic Improvement Scale (GAIS), with 95% of subjects reporting "improved or better" at 4 months and 90% at 7 months. The outcome of the physician GAIS was also high with 92% of patients classified as "improved or better" at 4 months and 97% at 7 months. There were only 2 device-related adverse events, both mild events related to Bellafill skin test (bruising, ecchymosis). There were no serious adverse events in response to the treatment product in this short-term follow-up study. CONCLUSION: Polymethylmethacrylate is effective for treating full-face acne scarring. Clinicaltrials.gov #NCT02642627.


Assuntos
Acne Vulgar/complicações , Cicatriz/terapia , Colágeno/administração & dosagem , Preenchedores Dérmicos/administração & dosagem , Polimetil Metacrilato/administração & dosagem , Adulto , Atrofia/diagnóstico , Atrofia/etiologia , Atrofia/terapia , Cicatriz/diagnóstico , Cicatriz/etiologia , Colágeno/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Equimose/diagnóstico , Equimose/etiologia , Face , Feminino , Seguimentos , Humanos , Injeções Intralesionais , Masculino , Polimetil Metacrilato/efeitos adversos , Estudo de Prova de Conceito , Índice de Gravidade de Doença , Testes Cutâneos/efeitos adversos , Resultado do Tratamento , Adulto Jovem
3.
J Drugs Dermatol ; 15(1 Suppl 2): s24-37, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26741392

RESUMO

Skin aging is a combination of multifactorial mechanisms that are not fully understood. Intrinsic and extrinsic factors modulate skin aging, activating distinctive processes that share similar molecular pathways. One of the main characteristics of youthful skin is its large capacity to retain water, and this decreases significantly as we age. A key molecule involved in maintaining skin hydration is hyaluronic acid (HA). Concentration of HA in the skin is determined by the complex balance between its synthesis, deposition, association with cellular structures, and degradation. HA bio-equivalency and bio-compatibility have been fundamental in keeping this macromolecule as the favorite of the skincare industry for decades. Scientific evidence now shows that topically applied HA is unable to penetrate the skin and is rapidly degraded on the skin surface. SkinMedica's HA5 Rejuvenating Hydrator (SkinMedica Inc., an Allergan company, Irvine, CA) promotes restoration of endogenous epidermal HA homeostasis and provides instant smoothing and hydration of the skin. These dual benefits are accomplished through the combination of 2 breakthrough technologies: 1) a unique blend of actives powered by SkinMedica proprietary flower-derived stem cell extract that restores the endogenous production of HA; and 2) a proprietary mix of 5 HA forms that plump the skin, decreasing the appearance of fine lines/wrinkles. Pre-clinical studies demonstrated that HA5 induces expression of key epidermal differentiation and barrier markers as well as epidermal HA synthases. A decrease expression of hyaluronidases was also observed upon HA5 application. Initial clinical studies showed that within 15 minutes of application, HA5 instantly improves the appearance of fine lines/wrinkles and skin hydration. Subjects that continue using HA5 (for 8 weeks) demonstrated significant improvements in fine lines/wrinkles, tactile roughness, and skin hydration. In summary, the blend of these 2 key technologies present in HA5 promotes restoration of endogenous epidermal HA while delivering instant smoothing effects.


Assuntos
Ácido Hialurônico/administração & dosagem , Rejuvenescimento , Envelhecimento da Pele/efeitos dos fármacos , Epiderme/efeitos dos fármacos , Epiderme/metabolismo , Homeostase , Humanos , Ácido Hialurônico/metabolismo , Hialuronoglucosaminidase/metabolismo , Pele/efeitos dos fármacos , Pele/metabolismo , Envelhecimento da Pele/fisiologia
4.
Dermatol Surg ; 41(12): 1351-60, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26606435

RESUMO

OBJECTIVE: This trial compares the effectiveness and safety of HYC-24L (Juvéderm Ultra XC; Allergan plc, Dublin, Ireland) (24 mg/mL of hyaluronic acid, 0.3% lidocaine) and CPM-22.5 (Belotero Balance; Merz Aesthetics, Raleigh, NC) (22.5 mg/mL of hyaluronic acid) for the treatment of perioral lines. MATERIALS AND METHODS: Men and women aged 35 years or older with moderate-to-severe perioral lines were recruited for this randomized controlled, rater-blinded, 2-arm trial. The primary endpoint was a comparison of rater-assessed responder rates by the validated 4-point Perioral Lines Severity Scale at Month 6; responders were those who showed a ≥1 point improvement. A secondary endpoint was subject-assessed change in perioral lines measured by the Global Assessment of Change Scale. RESULTS: A total of 136 subjects received treatment and 132 completed the trial (mean age: 58 ± 8 years). Total volume injected was 1.18 mL (HYC-24L) and 1.32 mL (CPM-22.5). At Month 6, a significantly greater proportion of HYC-24L subjects responded to treatment (87%) than CPM-22.5 subjects (72%) (p < .04). At all time points, HYC-24L subjects reported significantly greater improvement in their perioral lines than CPM-22.5 subjects, with the greatest difference at Month 6. No unexpected adverse events occurred. CONCLUSION: HYC-24L subjects showed a higher response rate and a greater improvement in their perioral lines than CPM-22.5 subjects for up to 6 months.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos/administração & dosagem , Ácido Hialurônico/administração & dosagem , Envelhecimento da Pele/efeitos dos fármacos , Contusões/etiologia , Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Estética , Face , Feminino , Humanos , Ácido Hialurônico/efeitos adversos , Injeções Subcutâneas/efeitos adversos , Masculino , Pessoa de Meia-Idade , Dor/etiologia , Dor/prevenção & controle
5.
J Am Acad Dermatol ; 71(1): 77-83, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24725475

RESUMO

BACKGROUND: Acne scarring remains a stubborn clinical problem. Few treatments have been shown to be definitely effective for this problem. Polymethylmethacrylate (PMMA) microspheres in collagen (ArteFill, Suneva Medical Inc, Santa Barbara, CA) have shown long-term benefit for nasolabial fold treatment. A pilot study has shown benefit for PMMA-collagen in atrophic acne scarring. OBJECTIVE: We sought to demonstrate the safety and effectiveness of PMMA-collagen for acne scarring in a controlled, blinded trial. METHODS: Subjects with at least 4 moderate to severe rolling, atrophic scars randomly received PMMA-collagen or saline injections. Subjects underwent up to 2 injection sessions and were followed up for 6 months. Efficacy was assessed using a validated rating scale for each scar. RESULTS: In all, 147 subjects underwent injections. Success was achieved by 64% of those treated with PMMA-collagen compared with 33% of control subjects (P = .0005). The treatment showed excellent safety with generally mild, reversible adverse events. No significant differences in efficacy or safety were noted between genders, for darker skin types, or in older age groups. LIMITATIONS: Subjects were followed up for only 6 months. CONCLUSION: PMMA-collagen demonstrates substantial effectiveness in the treatment of atrophic acne scars of the face while maintaining an excellent safety profile. Further follow-up should be undertaken to demonstrate longer-term benefit and safety.


Assuntos
Acne Vulgar/complicações , Cicatriz/terapia , Colágeno/administração & dosagem , Polimetil Metacrilato/administração & dosagem , Adulto , Cicatriz/etiologia , Cicatriz/patologia , Técnicas Cosméticas , Método Duplo-Cego , Face/patologia , Humanos , Masculino , Microesferas , Pessoa de Meia-Idade
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