Evaluation of the Volumizing Performance of a New Volumizer Filler in Volunteers with Age-Related Midfacial Volume Defects.

PURPOSE: The primary aim of this study was to evaluate the performance of the study product, in terms of volumizing activity as well as the duration of the effect, in women with age-related midfacial volume defects. In addition, the study allowed the evaluation of the tolerability of the product by both volunteers and investigators. PATIENTS AND METHODS: Twenty-two female volunteers, aged 42-60 years, participated in this study, which was performed under dermatological control in a single center. After an initial visit at baseline to verify adherence to the protocol criteria, volunteers received an injection of Aliaxin® SV (IBSA Farmaceutici Italia Srl), followed 3-4 weeks later by a second touch-up treatment to treat eventual asymmetries. Four subsequent visits, the last performed 9 months from the first injection, were performed to evaluate clinically and instrumentally the efficacy of the treatment. RESULTS: Clinical and statistically significant improvement in cheek volume was recorded after the first postinjection visit, and the effect was maintained until the end of the study period. A clinically measurable amelioration of wrinkle severity was also observed. By 3D picture recording and subsequent quantitative analysis, it was possible to determine the efficacy in terms of increased facial volume, which was already appreciable at the first visit, was further increased at the second and third visits and was maintained at the fourth and last visits. The injections were very well tolerated by the volunteers, as determined by their self-evaluation questionnaires. CONCLUSION: The results of the study confirm the esthetic performance of the study product on age-related midfacial volume defects. The very strong high-volumizing activity of the study product was not only properly determined by the investigators but also confirmed by self-evaluation by the volunteers. These effects were obtained with no appreciable undesired effects.

Efficacy and tolerability of a biomineral formulation for treatment of onychoschizia: a randomized trial.

Purpose: Onychoschizia causes lamellar splitting of the nail plate. It is a common problem seen by dermatologists therefore, an effective treatment is needed. The aim of this study was to evaluate the efficacy and tolerability of a biomineral formulation (Biomineral Unghie) applied topically, and/or as an oral supplement, in subjects with onychoschizia. Patients and methods: This single center, randomized, parallel-group, open-label study was conducted between March 2017 and June 2017. Fifty non-menopausal females aged 18 years or over with onychoschizia were randomized (1:1:1) into three treatment arms to receive either topical and/or oral biomineral formulation for 3 months. Subjects were randomized using a predefined randomization list. The primary objective was to determine the efficacy of the biomineral formulation. Results: Forty-eight subjects were included in the clinical assessment of nail hardness with 16 subjects in each treatment arm. After 3 months, fingernail hardness improved across the topical, oral and combined treatment arms compared with baseline: 40% (P<0.01 versus untreated hand), 43% and 50% (P<0.05 for both), respectively. Image analysis of the nail was carried out on 33 subjects with longitudinal and/or transversal fingernail grooves. Nail roughness was significantly reduced across all arms after 3 months compared with baseline (topical [n=11], -12%; oral supplement [n=10], -18%; combined topical/oral [n=12], -15%; all P<0.05). Subjects considered fingernail resistance, smoothness, glossiness, growth and general nail condition to be improved across all treatment arms. No adverse events were reported. Conclusion: The biomineral formulation was effective in improving nail condition in subjects with onychoschizia after 3 months.

Evaluation of the efficacy of a new hyaluronic acid gel on dynamic and static wrinkles in volunteers with moderate aging/photoaging.

PURPOSE: Aim of the study was to determine both clinically and by noninvasive instrumental evaluations the efficacy, tolerability and the duration of the effects of a new hyaluronic acid (HA) gel in human volunteers with moderate aging/photoaging. PATIENTS AND METHODS: Eighteen volunteers (35-55 years) were enrolled in this single-center study. The subjects underwent five visits. The first visit was at baseline to determine the adherence to the inclusion criteria, followed by the first injection of the HA-based study product, and the second visit was at 48 hours after the injection. Two months later, a second injection was given (Visit 3) followed by a subsequent visit (Visit 4) after 48 hours. The last visit (Visit 5) was performed 5 months after the first injection. Clinical and instrumental evaluations as well as self-assessment by the subjects were recorded at each visit. RESULTS: A significant improvement of wrinkles' grade around the eyes, vertical lip lines and wrinkles' severity of nasolabial folds was recorded after the first injection and the effect increased after the second injection. Aging/photoaging grade and surface microrelief improved 2 months after the first injection procedure. These clinical improvements were paralleled by amelioration of instrumental skin profilometry and optical colorimetry. The treatments were very well tolerated by the volunteers as determined by the self-grading score. CONCLUSION: The results confirm the good esthetic performance and the duration of the effect of the HA-based study product (Viscoderm® Hydrobooster) on dynamic facial wrinkles and/or static facial lines. These effects were particularly evident after the second injection and were accompanied by a good tolerability of the product.

Efficacy and tolerance of an injectable medical device containing stable hybrid cooperative complexes of high- and low-molecular-weight hyaluronic acid: a monocentric 16 weeks open-label evaluation.

BACKGROUND: An injectable medical device containing stable hybrid cooperative complexes of high- and low-molecular-weight hyaluronic acid (HA) has been developed with characteristics suited for a global improvement of facial esthetics. OBJECTIVE: To evaluate the HA product performance in improving some key facial esthetic features. The study employed clinical scales, subjective evaluations, and facial skin objective measurements. METHODS: A single Italian site treated 64 female subjects aged 38-60 years, with injections at five predetermined points, on each side of the face, with a 4-week time lapse between the first and the second product administration. Subjects were evaluated after 4, 8, 12, and 16 weeks, using validated clinical scales, subjective evaluation, and objective quantitative outcome measures. Assessment of esthetic results included photographic documentation. RESULTS: Both the clinical and subjective assessments, and the majority of objective instrumental parameters indicated an improvement throughout the study and were already significant at week 4 or 8 and were still significant at week 16 (3 months after the second treatment). Minor and temporary local skin reactions were observed in 23% of subjects at the site of the injections, and the global judgment on tolerability was good or excellent, both in the investigators' opinion and volunteers' self-evaluation. CONCLUSION: Both subjective and objective improvement of the facial parameters was consistent with the bio-remodeling purpose, and persistent and still statistically significant at the end of the study. The tolerability and safety profile of the product were judged good or excellent both by investigators and volunteers. This study supports the claim for bio-remodeling of these stable hybrid cooperative complexes of low- and high-molecular-weight HA.

An innovative approach to the topical treatment of acne.

Acne is characterized by primary lesions on the face, chest, and back, and by a variety of other signs and symptoms. In particular, acne inflammatory lesions result from Propionibacterium acnes colonization and are of particular relevance as they can cause permanent scarring. Acne also causes significant psychological morbidity in affected patients. Products currently available for the treatment of acne include systemic and topical treatments. As these products can cause severe side effects, new, innovative therapies are needed. Farmaka Acne Cream (FAC) is a novel, film-forming cream developed to treat mild and moderate acne. In vitro studies have demonstrated that FAC is as effective as 5% benzoyl peroxide in inhibiting growth of P. acnes. In 32 subjects with mild or moderate acne, FAC reduced all the major signs and symptoms of the disease. These included itching, erythema, and scaling, as well as reductions in the numbers of papules, pustules, and open and closed comedones. Acne severity improved in 38% of subjects, while none worsened. FAC was found to be effective in controlling sebum secretion, and was non-comedogenic. Most subjects (90%) reported tolerability as good or very good, while clinical efficacy and cosmetic acceptability were judged as good. For assessment of contact sensitization and photosensitization, FAC was applied daily to the backs of 29 subjects in two symmetric areas for 10 days. Using a solar stimulator, one minimal erythema dose was delivered to one side of the back from days 11 to 13. The four different subareas of treated/untreated and irradiated/nonirradiated and combinations thereof were compared. No cases of contact sensitization or photosensitization were observed, and FAC is considered safe for use in intense sunlight. In vitro and in vivo studies provide evidence for the safety and clinical benefits of FAC, a promising candidate for the treatment of mild and moderate acne.

Antiaging, photoprotective, and brightening activity in biorevitalization: a new solution for aging skin.

BACKGROUND: Age-related changes in the dermis can be considered the result of intrinsic factors and the consequence of environmental damage, mainly due to ultraviolet (UV) radiation from the sun (responsible for skin photoaging). The great versatility of the mesotherapy "biorevitalization" lies in the synergy between different biological effects of the active injected substances, which treats the skin in a more complete way. Several studies about biorevitalization efficacy showed good results. To date, however, objective results supported by instrumental evaluation are very sparse. PURPOSE: This study evaluated the efficacy of an injectable solution (32 mg of hyaluronic acid plus an antiaging antioxidant complex consisting of vitamins, minerals, and amino acids) in the treatment of skin aging and photoaging. METHODS: A total of 64 female volunteers (37-60 years) underwent four sessions of biorevitalization at 3-week intervals, involving multiple injections in the face (external corner of the eye and cheek), neck, décolletage, and back of the hands. The esthetic result was assessed at baseline and after 6, 9, and 12 weeks, and was established through the use of clinical and instrumental evaluations, supported by photographic documentation. Additionally, a phototest was performed to assess the effect of biorevitalization treatment on UVB-induced erythema. RESULTS: Instrumental assessment showed, as early as after the second biorevitalizing treatment, the antiaging efficacy of the tested product; there was a clinical and statistically significant improvement of profilometric parameters, skin brightness, pigmentation, and deep skin hydration. The study product induced a statistically significant decrease of the visual score of the UVB-induced erythema compared with baseline, which was statistically different from placebo. CONCLUSION: The study confirmed the well-known efficacy of biorevitalization in skin rejuvenation. The positive difference between deep and superficial skin hydration registered at the end of the trial suggested improved skin moisture retention of the stratum corneum. Furthermore, the obtained results suggest that the injected product could intervene at different moments of the skin pigmentation process by activating an intrinsic photoprotective mechanism and improving skin pigmentation quality. It may be that these processes employ common mechanisms in which antioxidants could play a pivotal role. This last hypothesis deserves further investigation.

A new dermal filler made of cross-linked and auto-cross-linked hyaluronic acid in the correction of facial aging defects.

BACKGROUND: A novel Hyaluronic Acid (HA) derivative dermal filler has been developed with characteristics especially suited for nasolabial folds (NLF) and facial defects due to volume loss. AIMS: An open-label prospective study was carried out to evaluate this HA filler's performance in correcting facial defects due to volume loss. METHODS: A single Italian site treated subjects aged 30-65 for facial defects due to volume loss with a new dermal filler injectable gel; subjects returned to the clinic at 7 and 14 days, and 1, 3, 6, 9, and 12 months for follow-up. The primary effectiveness endpoint was improvement in wrinkle severity (measured using the Wrinkle Severity Rating Scale) (WSRS) and facial volume (measured using the Facial Volume Loss Scale) (FVLS) at 6 and 12 months from baseline. Secondary endpoints were safety evaluation, performance duration, product handling, subjects' and investigator's treatment evaluation. Assessment of aesthetic results included the skin hydration, image analysis of nasolabial folds (3D), and photographic documentation. RESULTS: The reduction in nasolabial wrinkles was statistically significant at 6 months after the first implant. The aesthetic improvement of 1 grade on WSRS was evident in 95% of subjects up to 3 months, in 84% of subjects up to 6 months and in 27% up to 12 months. A clinically (> 1 point improvement) and statistically significant improvement in the FVLS was observed at each study visit; in 100% of treated cases, up to 3 months and in 61% up to 9 months. Good results were obtained during the study in skin hydration. There were no severe adverse events related to treatment. CONCLUSION: This injectable gel is well tolerated and has been demonstrated to provide a smooth and natural improvement in facial defects due to volume loss in nasolabial folds and the malar region that lasts for up to 1 year.

Preliminary open-label clinical evaluation of the soothing and reepithelialization properties of a novel topical formulation for rosacea.

BACKGROUND: Rosacea is a common, incurable skin barrier disorder characterized by relapses and remissions. PURPOSE: To evaluate the efficacy of Farmaka Rosacea Cream (FRC), a novel topical formulation for rosacea. METHODS: This single-center, open-label pilot study comprised a single-dose substudy in 20 healthy subjects and a long-term, repeat-dose substudy in 22 subjects with rosacea. The 2-hour, controlled, single-dose substudy assessed the soothing and reepithelialization properties of FRC after stripping-induced erythema based on the erythema index, transepidermal water loss, skin hydration, and clinical assessments of erythema. In the long-term substudy, subjects applied FRC twice daily for 8 weeks. Clinical assessments included vascular and pigmentary homogeneity and erythema and hemoglobin indices. Subjects completed questionnaires to assess FRC efficacy and cosmetic acceptability. RESULTS: Greater reductions were seen in FRC-treated areas compared with untreated areas for the erythema index (-16% versus -8%; P<0.001) and mean transepidermal water loss (-35.8% versus -10.1%; P<0.001) 30 minutes after stripping. Significant improvements over untreated areas were maintained 2 hours after stripping. Skin hydration and clinical erythema assessments also indicated that FRC soothed rosacea symptoms and promoted skin reepithelialization. Erythema and hemoglobin indices were significantly reduced from baseline after 4 and 8 weeks of treatment. Clinically assessed parameters were significantly improved following FRC application. Subjects assessed FRC positively. CONCLUSION: Improvement of rosacea symptoms was noted with FRC application. The main film-forming ingredients of FRC (trehalose, cholesterol, ceramide, and fatty acids), combined with other soothing and calming ingredients and ultraviolet filters, could explain its efficacy.