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1,501 result(s) for "Cosmetics - adverse effects"
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Controlled comparison evaluation of the soothing effect of 3 cosmetic products on skin discomfort induced by an irritant chemical agent (capsaicin)
Background Sensitive skin is a highly prevalent problem. The objective of the study was to assess whether the tested products are effective and safe in terms of improving the symptoms of sensitive skin. Methods A clinical randomized split‐face study was carried out on 24 healthy female subjects. Three cosmetic combinations were tested versus vehicle: product A (Solía Thermal Spring Water–TSW–from Cantabria, Spain + diatom algae–P. tricornutum–extract), product B (Solía TSW + diatom algae extract + Annona cherimola Fruit Extract) and product C (Solía TSW + diatom algae extract + Annona cherimola Fruit Extract + niacinamide). Prior to each application of the study Product (A, B, or C)/vehicle, 10% of aqueous solution of capsaicin to induce skin irritation was applied, mimicking the symptoms of sensitive skin. Stinging and burning sensations were evaluated at different time points. Results All three tested products A, B, and C showed to act better in calming the symptoms induced by capsaicin when compared to the vehicle. Conclusions The tested products would be an interesting option for treating stinging and burning sensations in sensitive skin patients.
Legal analysis of South Korean cosmetic filler litigations for safer medical practices
Cosmetic filler injections have gained popularity in recent years, but the rise in complications has led to an increase in legal disputes. This study analyzes civil court rulings related to cosmetic filler injection lawsuits in South Korea from 2007 to 2023. A retrospective case analysis was performed using a systematic database search, and a mixed-methods approach was employed for data analysis. The study examined 27 cases, revealing a high rate of liability findings against medical practitioners. Skin necrosis and blindness were the most common complications, and intravascular filler injection was recognized as negligence. Violation of informed consent was found in most cases, with mean compensation awards of ₩193,019,107 KRW ($142,831 USD) for first instance cases and ₩81,845,052 KRW ($60,564 USD) for second instance cases. The findings emphasize the importance of practitioner awareness, adherence to precautionary measures, and proactive prevention and management of complications. Collaboration among stakeholders is crucial for developing strategies that prioritize patient safety and minimize legal disputes in the aesthetic medicine industry. This study provides valuable insights for enhancing medical practices and safeguarding patient well-being in the field of cosmetic filler injections.
Effects of Thioglycolate Compounds in an Emerging Technique in the World of Cosmetics—Brow Lamination
Background The side effects of two related chemicals, ammonium thioglycolate (ATG) and thioglycolic acid (TGA) have been widely highlighted in the world of cosmetics. These thioglycolate compounds are considered essential ingredients in a new technique known as brow lamination. This technique is widely used nowadays, with the aim of changing the eyebrow shape. Aims To our knowledge, this is the first study to address the possible side effects of brow lamination. Results The hydrophilic characteristic of ATG and TGA reflects their transdermal absorption through the intracellular and transappendageal pathways. These compounds can affect the skin through allergic contact dermatitis (ACD), characterized by skin irritation, dryness, and erythema. Moreover, these thioglycolates can alter several mechanical and chemical reactions in the eyebrows' hair, therefore affecting their shape, structure, and pigmentation. In addition, these chemicals contained in brow lamination can exert systemic manifestations, at the level of the reproductive, ocular, respiratory, and endocrine systems. Conclusion More studies should be elaborated to shed light on the possible side effects of this trend. Additionally, further regulations should be taken into consideration to ensure the concentration and the measures applied are convenient to minimize these side effects.
Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V vs. Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial
Background Poly-L-lactic acid (PLLA) fillers have shown excellent results as soft tissue fillers for progressive midface volume enhancement, with long-lasting results and high patient satisfaction. Objective Herein, we investigated the safety and effectiveness of a new PLLA filler (Gana V) in comparison with those of the widely used Sculptra. Methods This double-blind, non-inferiority, randomized, split-face controlled trial was performed in France to evaluate the safety and effectiveness of injectable Gana V compared with those of Sculptra for correction of nasolabial fold (NLF) depression. The primary outcome was improvement in NLFs, as determined using the Wrinkle Severity Rating Scale (WSRS). This trial is an interim report of the results at 6 months. The trial was registered at ClinicalTrials. gov, number NCT05215054. Results Fifty-five participants with moderate-to-severe NLFs (mean age 53.8 [standard deviation 8.7] years; 48 [87.3%]) female) were enrolled. After 6 months, Gana V showed improved WSRS score (mean difference − 0.25; 95% confidence interval [CI] − 0.49 to − 0.01) in intention-to-treat analysis, while Sculptra did not (mean difference − 0.20; 95% CI − 0.42 to 0.03). Furthermore, Gana V showed an acceptable 6-month effectiveness compared with Sculptra, within our defined non-inferiority margin ( p non-inferiority = 0.1787). The immediate results by the investigator after the initial injection showed higher satisfaction in the Gana V than in the Sculptra group. Gana V and Sculptra showed no difference in adverse reactions. Similar patterns were observed in per-protocol analyses. Conclusions Gana V is non-inferior to Sculptra with respect to the correction of NLFs and has higher investigator satisfaction. Further research is required to ensure long-term safety. Level of Evidence I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
Therapeutic Performance of Needle Injection Versus Needle‐Free Jet Injector System for Polynucleotide Filler in Skin Rejuvenation
Background Polynucleotide (PN) filler often causes pain and can lead to delivery inaccuracies when applied via intradermal injection using a traditional needle. Aims To evaluate the efficacy of treatment and the pain during the procedure using conventional needle injection versus a needle‐free jet system for intradermal PN filler application. Methods In this split‐face clinical trial, 10 Korean subjects were enrolled. Each subject received an intradermal injection of PN filler on one side of the face and a needle‐free jet injection using CureJet on the other side. Assessments included global and 3D skin imaging at each visit. Pain intensity was evaluated using visual analogue scale (VAS) scores during the injection. Additionally, patient satisfaction and adverse events were documented. Results Findings revealed that Global Aesthetic Improvement Scale scores and patient satisfaction were significantly higher with the CureJet compared to the needle injection method. VAS scores were notably lower on the CureJet side. Improvements in both pore and wrinkle indices were observed from baseline, with a more pronounced improvement rate on the CureJet side compared to the needle injection side. Conclusions Needle‐free injection of PN for aging skin was found to be effective in enhancing pore and wrinkle improvement, while reducing associated discomfort.
A Randomized, Single‐Center, Double‐Blind, Controlled Case Study Evaluating Procedure Pairing of a Neurocosmetic Postprocedure Cream With Radiofrequency Microneedling for Facial Rejuvenation
Background Radiofrequency (RF) microneedling produces patient discomfort which deters patients from completing the recommended treatment series. Objective The primary objective was to determine the tolerability, safety, and efficacy of a neurocosmetic postprocedure cream post‐RF microneedling in reducing patient discomfort and enhancing recovery across the length of the study and, secondarily, to evaluate against a leading comparator. The third objective was to evaluate the efficacy of the neurocosmetic on self‐perceived improvement and objective grading. Materials and Methods An Institutional Review Board (IRB) approved, fourteen‐day, randomized, single‐center, double‐blind, controlled clinical case study was conducted with 11 healthy female subjects, 6 randomized to the neurocosmetic and 5 to the comparator cell. Following a 7‐day washout period, subjects received RF microneedling (face and neck) and applied the postprocedure cream twice daily for 7 days. Objective and subjective tolerability, self‐assessments, and clinical photography were performed immediately postprocedure, 24 h, three and seven days following the procedure. Results The neurocosmetic was tolerable and safe. Erythema and stinging immediately decreased postprocedure, postneurocosmetic application. After 24 h, 83% favorably agreed the neurocosmetic “reduced irritation on the skin post‐procedure,” and after 7 days, 100% favorably agreed “experience with the product was positive and I would be interested in returning for a second treatment.” The neurocosmetic reduced skin tone redness in the face and neck faster and to a greater degree when measured against a comparator. Conclusion The neurocosmetic postprocedure cream improved patient discomfort and enhanced recovery when used immediately post‐RF microneedling and after 7 days. IRB Protocol Number Pro00064211
Combined Novel Microfocused Ultrasound and Microneedle Fractional Radiofrequency System for Multilayered Facial Rejuvenation: A Prospective, Randomized, and Split‐Face Study
Background With the aging population, the demand for skin anti‐aging treatments has been steadily rising, prompting the development of advanced non‐invasive therapies. Aims To evaluate the efficacy and safety of microfocused ultrasound (MFU) combined with microneedle fractional radiofrequency (MFR) for facial rejuvenation. Methods This study involved 26 patients experiencing facial laxity. Each patient received one full‐face MFU treatment and one MFR treatment on one side of the face, which was randomly assigned. All treatments were performed on the same day. Facial photoaging parameters were assessed using VISIA, skin fat thickness changes were measured via ultrasound, and subjective evaluations were recorded at Months 0, 1, and 3. Side effects were recorded during treatments and each follow‐up visit. Results The VISIA analysis demonstrated notable enhancements in skin texture, wrinkles, pores, spots, and red areas on the combined treatment side. Ultrasound examinations revealed a significant reduction in subcutaneous fat thickness, particularly at the masseter and the middle of the cheek on the combined side. The study showed improvements in the Global Aesthetic Improvement Scale (GAIS) and Wrinkle Severity Rating Scale (WSRS) scores, with the combined treatment side outperforming the control side at the 3 month mark. Over 90% of participants expressed satisfaction with the treatment outcomes. Mild side effects, such as erythema, purpura, and edema, were observed but resolved without special interventions. Conclusions The combination of MFU and MFR for facial rejuvenation is both safe and effective. The combined treatment demonstrates superior enhancement in skin tightening, depigmentation, and pore refinement within a single therapeutic session.
Phase I Clinical Trial: Evaluating the Efficacy, Safety, and Patient Satisfaction of Platelet‐Rich Plasma (PRP) Injections and Microneedling for Androgenetic Alopecia Treatment
Introduction Platelet‐rich plasma (PRP) has been widely utilized in dermatological treatments, leading to the development of various administration methods. This study aims to evaluate and compare the effectiveness of PRP injections and microneedling techniques for treating androgenetic alopecia (AGA) in clinical practice. Materials and Methods A total of 40 participants diagnosed with AGA, aged between 18 and 50 years, were randomly assigned to receive either PRP injections or microneedling treatments. Each patient underwent two treatment sessions, with a 1‐month interval between them. Hair density and thickness measurements were performed using TrichoScan before treatment and 2 months after the final session. Statistical analysis was conducted using SPSS software. Results Among the participants, 28.57% were male and 71.43% were female, with an average age of 40.2 years (±7.7). In the PRP injection group, hair count increased by approximately 62.4% (from 17.40 ± 2.074 to 28.26 ± 6.229), and hair thickness improved by 58.6% (from 58.0 ± 25.01 to 92.0 ± 16.31). In the microneedling group, hair count increased by 88.4% (from 14.71 ± 3.988 to 27.71 ± 4.499), while hair thickness improved by 51.3% (from 49.0 ± 11.30 to 74.14 ± 22.42). Although both groups showed statistically significant improvements (p < 0.05), the intergroup differences in hair count and thickness were not statistically significant (p > 0.05). Conclusion The findings of this study confirm PRP as a viable treatment option for AGA. Both injection and microneedling methods provided therapeutic benefits. Additionally, microneedling appeared to enhance patient satisfaction and treatment tolerance.
Efficacy of Carboxytherapy Mask in Post‐Fractional Ablative Laser Recovery: A Randomized Pilot Trial
Background Fractional ablative CO2 lasers are widely used for skin rejuvenation but are associated with post‐procedural erythema, crusting, tenderness, and downtime. Carboxytherapy masks, a modality utilizing carbon dioxide, have been suggested to enhance healing and aesthetic outcomes post CO2 laser treatment; however, controlled clinical data remain limited. Objective To evaluate the efficacy and safety of a topical carboxytherapy mask in enhancing recovery, reducing adverse effects, and improving patient satisfaction following fractional ablative CO2 laser treatment. Methods Ten subjects (aged 45–70 years, Fitzpatrick skin types I–III) undergoing full‐face fractional CO2 laser resurfacing were enrolled in this randomized pilot study. Participants were assigned to either the active arm (n = 8, carboxytherapy mask was applied pre‐ and post‐procedure and at designated intervals for 14 days) or placebo arm (n = 2, bland moisturizer). Outcomes included blinded investigator assessments of erythema, edema, crusting, healing rate, pigmentation, and wrinkle severity at Days 28 and 84; patient‐reported diaries of discomfort and healing parameters; and self‐assessments of satisfaction and global aesthetic improvement. Results The active group demonstrated reduced erythema during the first week (mean scores: Day 1, 3.1 vs. 3.5; Day 7, 0.6 vs. 1.0 for placebo). By Day 7, healing surface area averaged 97% in the active group with no crusting. At Day 28, the active group exhibited fewer fine and coarse lines (mean coarse line score 2 vs. 4 in placebo). At Day 84, coarse line reduction and abnormal pigmentation improvement favored the active group (0.75 vs. 1.5, respectively). Patient‐reported tenderness, burning, and crusting were consistently lower in the active group, with higher satisfaction and confidence scores at both Day 28 and 84. No adverse effects were reported. Conclusion In this pilot study, the carboxytherapy mask enhanced post‐laser healing, reduced erythema and discomfort, and improved long‐term wrinkle and pigmentation outcomes compared to placebo. These findings support the adjunctive use of the carboxytherapy mask to improve recovery and patient satisfaction after ablative CO2 laser resurfacing. Larger, controlled trials are warranted to confirm these results.
A prospective multicenter clinical trial evaluating the efficacy and safety of a hyaluronic acid‐based filler with Tri‐Hyal technology in the treatment of lips and the perioral area
Background Age‐related changes of facial soft tissue cause clinical signs of facial aging such as lip atrophy, marionette lines, and an accentuated nasolabial fold. These changes can be modified using dermal fillers. Aims To evaluate efficacy, longevity, and safety of a cross‐linked hyaluronic acid‐based filler with Tri‐Hyal technology in the treatment of lips, nasolabial folds, and marionette lines. Materials and Methods This prospective, multi‐center trial evaluated injections of three different areas (lips, nasolabial fold alone, or with marionette wrinkles) with a soft tissue filler containing 25 mg/ml cross‐linked hyaluronic acid and 0.3% lidocaine. Primary endpoint was the aesthetic correction 3 weeks after one injection session without touch‐up. Follow‐up was 18 months. Assessments were performed using the Global Aesthetic Score (GAS), clinical scoring based on photographic scales, high‐frequency ultrasound imaging, and the Global Aesthetic Improvement Scale (GAIS). Results In total, 100 subjects were injected. GAS improved significantly for all treatment indications at 3 weeks (p < 0.0001). Success rates were highest for nasolabial folds (98.4%), followed by marionette lines (94.4%) and lips (73.5%). After 18 months post‐injection, success was observed in 91%, 88%, and 33% of subjects injected into nasolabial folds, marionette lines, and lips, respectively. GAIS scored highest for nasolabial folds (SGAIS: 71%; IGAIS: 40%), followed by marionette lines (SGAIS: 56%; IGAIS: 33%) and lips (SGAIS: 30%; IGAIS: 22%) at 18 months follow‐up. Conclusions The filler demonstrated high efficacy and safety in all indications. Regional differences in longevity were evident. Thus, the necessity of regional retreatments should be discussed with patients before injection.