Efficacy and safety of a new hyaluronic acid filler for nasolabial folds: A 52-week, multicenter, randomized, evaluator/subject-blind, split-face study.

BACKGROUND: Hyaluronic acid fillers are known to be effective for correction of nasolabial folds. Recently, a novel biphasic hyaluronic acid filler incorporating lidocaine, DIVAVIVA medium has been introduced. OBJECTIVES: We compared the efficacy and safety between DIVAVIVA medium and Restylane Perlane Lidocaine for moderate to severe nasolabial folds. METHODS: This was a multicenter, randomized, evaluator/subject-blind, active-controlled, split-face study. A study 1 evaluated the efficacy and safety until 24 weeks. Extension study, study 2, included subjects who wanted to enroll and evaluated the efficacy and safety until 52 weeks. The Wrinkle Severity Rating Scale (WSRS) score, Global Aesthetic Improvement Scale, and Visual Analogue Scale measuring pain were evaluated. All adverse events were monitored. RESULTS: The mean change of WSRS at week 24 was -0.61 ± 0.54 in DIVAVIVA medium group and -0.59 ± 0.49 in Restylane Perlane Lidocaine group. The difference between two groups was 0.08, which was lower than noninferior limit. In study 2, the mean change of WSRS score at week 52 from baseline was -0.01 ± 0.62 in DIVAVIVA group, 0.06 ± 0.57 in Restylane Perlane Lidocaine group. The primary and secondary efficacy outcomes were also achieved in study 1 and 2. There was no significant difference in the incidence of adverse events between the two groups. CONCLUSION: DIVAVIVA medium has comparable efficacy and safety with Restylane Perlane Lidocaine for correction of moderate to severe nasolabial folds.

Efficacy and Safety of Prabotulinumtoxin A and Onabotulinumtoxin A for Crow's Feet: A Phase 3, Multicenter, Randomized, Double-Blind, Split-Face Study.

BACKGROUND: Prabotulinumtoxin A has been shown to have efficacy for the treatment of upper-limb spasticity and improvement of moderate to severe glabellar lines. However, the efficacy and safety of prabotulinumtoxin A for crow's feet have not been evaluated. OBJECTIVE: This study compared the efficacy and safety of prabotulinumtoxin A and onabotulinumtoxin A in the treatment of crow's feet. PATIENTS AND METHODS: A multicenter, randomized, double-blind, active-controlled, split-face study was conducted in subjects with bilateral symmetric, moderate to severe crow's feet at maximum smile. The investigators assessed the severity of crow's feet by using the facial wrinkle scale, and the subjects reported the improvement in severity, their subjective satisfaction, and perceived age. The primary efficacy outcome was the proportion of subjects with Grade 0 or 1 severity of crow's feet at maximum smile at Week 4 as assessed by the investigators. RESULTS: In the primary efficacy outcome assessment, there was no significant difference between the 2 groups (prabotulinumtoxin A, 65.02%; onabotulinumtoxin A, 62.56%; p = .0956). All secondary efficacy outcomes were also achieved. Adverse events related to injection were mild and recovered spontaneously. CONCLUSION: Prabotulinumtoxin A and onabotulinumtoxin A have comparable efficacy and safety in the treatment of crow's feet.

Assessment of Skin Physiology Change and Safety After Intradermal Injections With Botulinum Toxin: A Randomized, Double-Blind, Placebo-Controlled, Split-Face Pilot Study in Rosacea Patients With Facial Erythema.

BACKGROUND: Botulinum toxin (BTX) has been used cosmetically with good clinical efficacy and tolerable safety. OBJECTIVE: This randomized, double-blind, split-face clinical study aimed to investigate the efficacy and safety of intradermal BTX in patients with rosacea. MATERIALS AND METHODS: Twenty-four participants were enrolled and randomly given intradermal injections of BTX and normal saline in both cheeks. Clinician Erythema Assessment (CEA) score, Global Aesthetic Improvement Scale (GAIS) score, skin hydration, transepidermal water loss (TEWL), melanin content, erythema index, elasticity, and sebum secretions were evaluated at baseline and 2, 4, 8, and 12 weeks. RESULTS: On the BTX-treated side, the CEA score significantly decreased and the GAIS score significantly increased. The erythema index decreased at Weeks 4 and 8. Skin elasticity was improved at Weeks 2 and 4 and skin hydration, at Weeks 2, 4, and 8. However, TEWL and sebum secretion did not show significant differences. CONCLUSION: Intradermal BTX injections reduced erythema and rejuvenated the skin effectively and safely in patients with rosacea.

Flavonoid Silibinin Increases Hair-Inductive Property Via Akt and Wnt/ß-Catenin Signaling Activation in 3-Dimensional-Spheroid Cultured Human Dermal Papilla Cells.

Hair loss, also known as alopecia, is a common dermatological condition of psychosocial significance; development of therapeutic candidates for the treatment of this condition is, hence, important. Silibinin, a secondary metabolite from Silybum marianum, is an effective antioxidant that also prevents various cutaneous problems. In this study, we have investigated the effect of silibinin on hair induction using three-dimensional (3D) cultured, human dermal papilla (DP) spheroids. Silibinin was found to significantly increase viability through AKT serine/threonine kinase (AKT) activation in 3D DP spheroids. This was correlated with an increase in the diameter of the 3D DP spheroids. The activation of the wingless and INT-1 (Wnt)/ß-catenin signaling pathway, which is associated with hair growth induction in the DP, was evaluated using the T cell-specific transcription factor and lymphoid enhancer-binding factor (TCF/LEF) transcription factor reporter assay; results indicated significantly increased luciferase activity. In addition, we were able to demonstrate increased expression of the target genes, WNT5a and LEF1, using quantitative real-time PCR assay. Lastly, significantly elevated expression of signature genes associated with hair induction was demonstrated in the 3D DP spheroids treated with silibinin. These results suggest that silibinin promotes proliferation and hair induction through the AKT and Wnt/ß-catenin signaling pathways in 3D DP spheroids. Silibinin can be a potential candidate to promote hair proliferation.

Analysis of the skin mycobiome in adult patients with atopic dermatitis.

With the recent availability of culture-independent sequencing methods, studies have been conducted to analyse skin micro-organisms present in patients with atopic dermatitis (AD). However, the database on the skin fungal communities, "mycobiome," has been relatively restrictive compared with the bacterial world. We aimed to comparatively analyse the overall skin mycobiome between patients with AD and healthy individuals in the Korean population. We analysed skin swab samples obtained from the antecubital fossae of 8 patients with AD and 8 healthy controls. Using sequencing method followed by direct DNA extraction and molecular PCR, taxonomic compositions of fungi at stepwise level ranks were analysed. The phylogenic marker used was internal transcribed spacer 2 regions of DNA. We observed the tendency of higher intra- and interpersonal taxonomic diversity at genus and species levels in AD samples. Non-Malassezia fungal diversity was also noticeable in the patient group compared with healthy controls. Malassezia globosa and Malassezia restricta were prevalent in all samples across both study groups, and some Malassezia species, including Malassezia sloofiae and Malassezia dermatis, characterized AD. Our data might provide a new insight into the mycobiome of adult AD, which contributes to building a systemic mycobiome database in AD.