Efficacy and safety of topical brepocitinib cream for mild-to-moderate chronic plaque psoriasis: a phase IIb randomized double-blind vehicle-controlled parallel-group study.

BACKGROUND: Plaque psoriasis (PsO) is an inflammatory skin disease driven, in part, by the activation of Janus kinase (JAK) signalling pathways. OBJECTIVES: To assess the efficacy and safety of multiple doses of topical brepocitinib, a tyrosine kinase 2/JAK1 inhibitor, in participants with mild-to-moderate PsO. METHODS: This phase IIb multicentre randomized double-blind study was conducted in two stages. In stage 1, participants received one of eight treatments for 12 weeks: brepocitinib 0.1% once daily, 0.3% once or twice daily, 1.0% once or twice daily, 3.0% once daily, or vehicle once or twice daily. In stage 2, participants received brepocitinib 3.0% twice daily or vehicle twice daily. The primary endpoint was the change from baseline in Psoriasis Area and Severity Index (PASI) score at week 12, analysed using analysis of covariance. The key secondary endpoint was the proportion of participants who achieved a Physician Global Assessment response [score of clear (0) or almost clear (1) and an improvement of ≥ 2 points from baseline] at week 12. Additional secondary endpoints included the difference vs. vehicle in change from baseline in PASI, using mixed-model repeated measures, and the change from baseline in Peak Pruritus Numerical Rating Scale at week 12. Safety was monitored. RESULTS: Overall, 344 participants were randomized. Topical brepocitinib did not result in statistically significant changes compared with respective vehicle controls in the primary or key secondary efficacy endpoints for any dose group. At week 12, least squares mean change from baseline in PASI score ranged from -1.4 to -2.4 for the brepocitinib once-daily groups vs. -1.6 for vehicle once daily, and from -2.5 to -3.0 for the brepocitinib twice-daily groups vs. -2.2 for vehicle twice daily. From week 8, change from baseline in PASI score separated from vehicle in all brepocitinib twice daily groups. Brepocitinib was well tolerated, with adverse events (AEs) occurring at similar rates across groups. One participant in the brepocitinib 1.0% once-daily group developed a treatment-related AE of herpes zoster in the neck area. CONCLUSIONS: Topical brepocitinib was well tolerated but did not result in statistically significant changes compared with vehicle when administered at the doses evaluated to treat signs and symptoms of mild-to-moderate PsO.

The Second of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as independently assessed by both investigator and patient on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment (IT) of 20 U prabotulinumtoxinA (4 U/0.1 mL final vacuum-dried formulation injected into 5 glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety outcomes were evaluated throughout the study. RESULTS: The 570 study patients received a median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug-related AEs after the IT. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Eight patients (1.4%) experienced study drug-related AEs of special interest: 5 experienced eyelid ptosis (0.9%), 3 eyebrow ptosis (0.5%), 1 blepharospasm (0.2%), and 1 blurred vision (0.2%). Seven patients (1.2%) experienced serious AEs, but none were study drug related. A total of 4060 serum samples were tested for antibotulinum toxin antibodies; no seroconversion was observed. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was confirmed in this second phase II study based on a broad range of outcomes.

Hydrogen Peroxide Topical Solution, 45% for Common Warts: Phase 2 Efficacy and Safety Trial Results.

BACKGROUND: No FDA-approved prescription therapies are available for common warts. OBJECTIVE: We evaluated a proprietary hydrogen peroxide topical solution, 45% (w/w) (HP45) for treatment of common warts. METHODS: In the phase 2 randomized, double-blind, vehicle-controlled WART-203 trial (NCT03278028), eligible patients aged ≥8 years had 1–6 warts (1 target wart) on the trunk or extremities with a Physician’s Wart Assessment™ (PWA) grade ≥2 (range, 0 [clear] to 3 [wart 3–8 mm in diameter or length]). Patients self-administered HP45 or vehicle twice weekly for 8 weeks and were evaluated through 12 weeks posttreatment (week 20). Efficacy assessments included mean change in target wart PWA grade from baseline at week 8 (primary endpoint) and proportions of patients with target wart clearance. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs). RESULTS: A total of 157 patients completed 8 weeks of treatment (HP45, n=79; vehicle, n=78); 151 patients completed the 20-week posttreatment evaluation (HP45, n=75; vehicle, n=76). A significantly greater reduction in mean target wart PWA grade from baseline at week 8 was achieved with HP45 (−0.87) vs vehicle (−0.17; P<0.0001) and maintained at week 20 (−1.00 vs −0.39; P=0.0004). The proportion of patients with target wart clearance at week 8 was significantly greater with HP45 (25.3%) vs vehicle (2.6%; P<0.0001) and remained significantly greater at week 20 (37.3% vs 11.8%; P=0.0002). Forty-seven patients reported 76 TEAEs; most were mild or moderate in severity. Most LSRs were mild and resolved by week 20. In pediatric patients (HP45, n=13; vehicle, n=6), greater reductions in mean target wart PWA grade from baseline were observed with HP45 vs vehicle at weeks 8 (−1.0 vs 0) and 20 (−1.2 vs −0.5). CONCLUSION: These findings support the efficacy and safety of HP45 for the treatment of common warts in patients ≥8 years of age. J Drugs Dermatol. 2020;19(10):969-976. doi:10.36849/JDD.2020.5054.

Anatomic Site-Specific Treatment Response With 40% Hydrogen Peroxide (w/w) Topical Formulation for Raised Seborrheic Keratoses: Pooled Analysis of Data from Two Phase 3 Studies.

OBJECTIVE: Seborrheic keratoses (SKs) may present in any non-glabrous skin, but data are limited on the response to treatment as based on the SK location. We aimed to understand the relationship between SK location and clearance with up to 2 treatments of 40% (w/w) hydrogen peroxide topical solution (HP40). METHODS: We conducted a sub-analysis of data pooled from two randomized, double-blind, vehicle (VEH)-controlled clinical trials, including 937 patients, each with 4 target SKs (N=3,748 SKs), with at least 1 on the face and 1 on the trunk or extremities. Treatment response was defined as 0 or 1 on a 4-point Physician's Lesion Assessment (PLA) scale (0=clear; 1=near-clear) after up to 2 applications, 3 weeks apart, and was assessed by SK location (face, trunk, and extremity). Local skin reactions were stratified by anatomic location and categorized based on immediate and delayed post-treatment reactions. Sensitivity analysis was conducted using the mean-per-patient (MPP) percent of SKs that are clear or near-clear at day 106. RESULTS: Treatment response was greater with HP40 versus VEH regardless of anatomic location of the SK. Clear or near-clear SKs with HP40 was observed in 65% of facial SKs (vs 10% VEH), 46% of truncal SKs (vs 5% VEH), and 38% of extremity SKs (vs 9% VEH). Facial SKs were more likely to be clear or near clear after a single treatment (43%), versus SKs on the trunk (31%) or extremities (14%). Most common immediate reactions with HP40 were erythema, stinging, and edema, which resolved to none or mostly mild within a week. Delayed reactions such as dyspigmentation and scarring occurred at low rates and were least reported for the facial SKs. CONCLUSIONS: SK clearance with HP40 was highest among SKs on the face and lowest among SKs on the extremities. Dyspigmentation rates were lowest among SKs treated on the face. Anatomic location of SK was a predictor of both treatment response and risk of dyspigmentation with HP40 application. ClinicalTrials.gov listings: NCT02667236 and NCT02667275 J Drugs Dermatol. 2018;17(10):1092-1098.

Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w), in patients with seborrheic keratoses: Results from 2 identical, randomized, double-blind, placebo-controlled, phase 3 studies (A-101-SEBK-301/302).

BACKGROUND: Approved topical treatments for seborrheic keratoses (SKs) are an unmet need. OBJECTIVE: To evaluate the safety and efficacy of 40% hydrogen peroxide topical solution (HP40) versus vehicle for the treatment of SKs (A-101-SEBK). METHODS: A total of 937 patients with 4 SKs each (≥1 lesion each on the face and on the trunk and/or an extremity) were randomized 1:1 to HP40 or vehicle. At each visit, SKs were graded using the Physician's Lesion Assessment (PLA) scale (0, clear; 1, nearly clear; 2, ≤1 mm thick; and 3, >1 mm thick). After 1 treatment, SKs with a PLA score higher than 0 were re-treated 3 weeks later. RESULTS: At day 106, significantly more patients treated with HP40 than with vehicle achieved a PLA score of 0 on all 4 SKs (study 1, 4% vs 0%; study 2, 8% vs 0% [both P < .01]) and on 3 of 4 SKs (study 1, 13% vs 0%; study 2, 23% vs 0% [both P < .0001]). A higher mean per-patient percentage of SKs were clear (study 1, 25% vs 2%; study 2, 34% vs 1%) and clear or nearly clear (study 1, 47% vs 10%; study 2, 54% vs 5%) with HP40 than with vehicle. Local skin reactions were largely mild and resolved by day 106. LIMITATIONS: The optimal number of treatment sessions was not evaluated. CONCLUSION: Application of HP40 was well tolerated and effective in the removal of SKs.

Five-Year Safety and Satisfaction Study of PMMA-Collagen in the Correction of Nasolabial Folds.

BACKGROUND: A polymethylmethacrylate-collagen filler is generally believed to give long-term benefits, but the risk of granuloma formation over time remains unclear. OBJECTIVE: To determine the incidence of granuloma formation and response to treatment and assess the degree of patient satisfaction over 5 years. MATERIALS AND METHODS: Adults seeking correction of nasolabial folds underwent up to 3 injection sessions over 2 months. Subjects were then queried regularly for the development of signs and symptoms of a granuloma. Any positive responses were evaluated, and lesions suspicious for granulomas were confirmed by biopsy. Granulomas were treated at the discretion of the investigator. Subjects also completed regular satisfaction questionnaires. RESULTS: A total of 1,008 subjects were enrolled and 871 completed the full 5 years of the study. A biopsy-confirmed granuloma developed in 1.7% of subjects. Almost all granulomas responded to treatment. At study exit, 0.9% of subjects had an unresolved granuloma. Patient satisfaction remained high throughout the duration of the study. CONCLUSION: The incidence of granuloma formation with a polymethylmethacrylate-collagen dermal filler is low, and almost all lesions are manageable with simple therapeutic measures. Patient satisfaction remains durable over 5 years. Polymethylmethacrylate-collagen offers a well-characterized and very favorable risk/benefit profile.

Functional safety assessments used in a randomized controlled study of small gel particle hyaluronic acid for lip augmentation.

BACKGROUND: Dermal fillers are commonly injected in the lips for aesthetic treatment. Small gel particle hyaluronic acid (SGP-HA) is the only filler approved by the US Food and Drug Administration for this indication, based on a pivotal trial of effectiveness and safety. OBJECTIVE: To assess multiple measures of tolerability and lip function in a randomized controlled trial of SGP-HA (without lidocaine) for lip augmentation. MATERIALS AND METHODS: Patients were randomized to SGP-HA (n = 135) or no treatment (n = 45) at baseline; all could receive SGP-HA after 6 months. Assessments for tolerability and lip function at clinic visits throughout the study included lip texture, firmness, symmetry, movement, function, and sensation; device palpability; mass formation; and ease of repeat injection. RESULTS: Many assessments were normal (lip function, sensation) or unremarkable (movement, mass formation, ease of reinjection) in most patients. Nearly all abnormalities with other assessments (texture, firmness, symmetry, device palpability) were mild and transient (<4 weeks). CONCLUSION: Lip augmentation with SGP-HA showed excellent safety with the assessments used in this study. Further study should be conducted to validate these assessments with the goal of developing a comprehensive scale for measuring potential functional complications and risks.

A double-blind, randomized, multicenter, controlled trial of suspended polymethylmethacrylate microspheres for the correction of atrophic facial acne scars.

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.

Small gel particle hyaluronic acid injection technique for lip augmentation.

Optimizing the aesthetic outcome of lip augmentation with dermal fillers, such as small gel particle hyaluronic acid (SGP-HA), requires skillful application of a suitable injection technique. Moreover, achieving aesthetic goals with minimal risk for adverse events requires knowledge of lip anatomy and function, clinical experience in the use of various injection techniques, and an individualized treatment approach. Clinician-patient discussion of the initial assessment of lip presentation and global appearance of lip shape and proportion is important in setting treatment expectations and establishing a basis for follow-up assessment of the effectiveness of treatment. The effectiveness and safety of SGP-HA for lip augmentation was demonstrated in a recent randomized controlled trial. This review discusses factors influencing the choice of one or a combination of techniques for injection of SGP-HA for aesthetic lip augmentation.

Validation of a lip fullness scale for assessment of lip augmentation.

BACKGROUND: Given the growing use of dermal fillers for cosmetic lip augmentation, a validated instrument with which to measure lip fullness is desirable in the clinic and as an efficacy endpoint in clinical studies. The authors developed and conducted a validation study of a Medicis-developed lip fullness scale. METHODS: The Medicis Lip Fullness Scale consists of separate five-point scales for the upper and lower lips, with three photographs exemplifying each grade. Five board-certified dermatologists or plastic surgeons assessed 85 test photographs for each lip on two separate occasions for the first round of validation (photograph versus photograph). Three of the evaluators also graded lip fullness in 39 live subjects, followed 2 weeks later by scoring of the same subjects' photographs for the second round of validation (live versus photographic). RESULTS: Within-observer agreement between the two sequential photographic evaluations was almost perfect (weighted κ = 0.81). Between-observer weighted κ values ranged from 0.60 to 0.83 for the upper lip and 0.61 to 0.82 for the lower lip. Exact agreement between the live and photographic assessments of the same subjects was 60 percent and 52 percent for upper and lower lips, respectively. CONCLUSIONS: The Medicis Lip Fullness Scale showed high interrater and intrarater reliability in comparisons of test photographs and moderate to substantial reliability in live assessment of patients versus photographs. The Medicis Lip Fullness Scale is suitable for grading lip fullness in clinical trials. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, III.

A multicenter, double-blind, placebo-controlled trial of autologous fibroblast therapy for the treatment of nasolabial fold wrinkles.

BACKGROUND: Changes associated with aging are partly due to loss of collagen and elastin. Treatment with autologous fibroblasts grown in culture (azficel-T) can help correct the appearance of aging by replacing lost dermal constituents. OBJECTIVE: To demonstrate the safety and effectiveness of autologous fibroblasts in the treatment of nasolabial fold (NLF) wrinkles. METHODS AND MATERIALS: Adults with moderate to very severe NLF wrinkles were randomized to receive three treatments with autologous fibroblasts or placebo at 5-week intervals. Blinded evaluators and subjects assessed efficacy using a validated wrinkle assessment scale. RESULTS: Three hundred seventy-two subjects were enrolled and underwent treatment. Seventy-eight percent of subjects treated with autologous fibroblast therapy and 48% of subjects treated with placebo achieved at least a 1-point improvement on the subject assessment at 6 months (p < 0.001), and 64% of subjects treated with autologous fibroblast therapy and 36% of those treated with placebo showed at least a 1-point improvement evaluator's assessment (p < 0.001). Adverse events were generally mild, and the treatment was well tolerated. CONCLUSION: Autologous fibroblast therapy is safe and effective for the treatment of NLF wrinkles. The availability of autologous cell therapy marks the beginning of a new phase in aesthetic therapy.

A randomized, blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study.

BACKGROUND: Duration of effect and effectiveness limit current options for treating axillary hyperhidrosis. A new microwave procedure for treatment of axillary hyperhidrosis has been tested. STUDY DESIGN/MATERIALS AND METHODS: Adults with primary axillary hyperhidrosis were enrolled in a randomized, sham-controlled, blinded study. Subjects were required to have a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 and baseline sweat production greater than 50 mg/5 min. Procedures were administered using a proprietary microwave energy device that isolates and heats target tissue. Responders were defined as subjects reporting a HDSS score of 1 or 2. Subjects were followed for 6 months (sham group) or 12 months (active group). RESULTS: Thirty days after treatment, the active group had a responder rate of 89% (72/81), and the sham group had a responder rate of 54% (21/39) (P < .001). Treatment efficacy was stable from 3 months (74%) to 12 months (69%), when follow-up ended. Adverse events were generally mild, and all but one resolved over time. CONCLUSIONS: The procedure demonstrated statistically significant, long-term efficacy in sweat reduction. As with any new procedure, findings from this first investigational device study identified optimization strategies for the future.

Duration of wrinkle correction following repeat treatment with Juvéderm hyaluronic acid fillers.

Many patients elect to have repeat treatments with hyaluronic acid dermal fillers to maintain wrinkle correction, but the clinical performance of these products after repeat treatments has not been formally assessed. The primary objective of this study was to evaluate the effectiveness of Juvéderm injectable gel (Juvéderm Ultra, Juvéderm Ultra Plus, and Juvéderm 30) through 1 year after repeat treatment of nasolabial folds (NLFs) that were previously treated with Juvéderm or Zyplast 6-9 months prior to the repeat treatment. Upon completion of the pivotal IDE clinical trial for Juvéderm, five of the original 11 study sites were selected to participate in an extended follow-up evaluation, and a total of 80 subjects were enrolled. For the Juvéderm-treated NLFs in each treatment group, the median injection volume was 1.5-1.6 mL for initial treatment but only 0.5-0.6 mL for the repeat treatment (p < 0.0001). Mean Investigator-assigned NLF severity scores on a scale of 0-4 for the Juvéderm-treated NLFs improved from 2.5-2.7 (moderate to severe) at baseline to 1.2-1.5 (mild) just prior to repeat treatment (>24 weeks) and 0.7-0.9 (mild) at 4 weeks after repeat treatment. At 48 weeks post-repeat treatment, the mean NLF scores were 1.1-1.3 (mild), and 78-90% of subjects were considered responders (≥1 point improvement). Thus, subjects sustained a total of 18-21 months of wrinkle correction with a repeat treatment at 6-9 months and needed substantially less filler (60% less) for repeat treatment than for initial treatment, indicating that retreatment at this timepoint may be beneficial to patients.

Reduction in facial photodamage by a topical growth factor product.

A topical gel containing a proprietary mixture of over 110 growth factors, cytokines, and soluble matrix proteins secreted by human dermal fibroblasts was evaluated for safety and efficacy in the treatment of mild to severe facial photodamage. In a double-blind study, 60 subjects were randomly assigned to receive either active gel or the vehicle and applied twice daily for 6 months along with a moisturizing cleanser and sunscreen. Efficacy (profilometry, photography, and clinical assessment) and safety (adverse event reporting) measures were evaluated at 0, 3, and 6 months. Treatment with the active gel for 3 months produced greater reduction in fine lines and wrinkles than the vehicle treatment as measured by objective and subjective assessment techniques. The results were either statistically significant (P < or = .05) or trending towards statistical significance (P < or = .1). This study demonstrates that addition of a topical formulation of growth factors and cytokines to a basic skin care regimen reduces the signs of photoaging.

Twelve-month persistency of a novel ribose-cross-linked collagen dermal filler.

BACKGROUND: The porcine collagen-derived dermal filler Dermicol-P35 (Evolence, Colbar LifeScience Ltd, Herzliya, Israel) has low immunogenicity and the potential to provide a long-lasting corrective response for soft-tissue contour deficiencies and deformities. OBJECTIVE The objective was to assess the persistence of the corrective response with Dermicol-P35 up to 12 months after obtaining an optimal cosmetic result (OCR) in a randomized, multicenter study comparing the efficacy and safety of Dermicol-P35 with the hyaluronic acid (HA) filler Restylane (Medicis Pharmaceutical Co.). METHODS & MATERIALS: Subjects with moderate to deep nasolabial wrinkles (n=149) were randomized to injections of either Dermicol-P35 or HA on one side of the face and the alternative preparation on the contralateral side. If necessary, one touch-up injection could be given after 2 weeks to obtain an OCR. RESULTS: Although the mean Modified Fitzpatrick Wrinkle Scale score increased gradually after achieving the OCR with Dermicol-P35, 95.3 and 76.5% of subjects, respectively, met the criteria for persistence of the corrective response after 9 and 12 months. Persistency rates were similar regardless of the requirement for a touch-up injection at Week 2. No unexpected, severe, or serious injection-related adverse events were experienced. CONCLUSION: The effectiveness of Dermicol-P35 appears to be maintained for up to 1 year after achieving an OCR, both for touch-up and for non-touch-up subjects.

Effectiveness of Juvéderm Ultra Plus dermal filler in the treatment of severe nasolabial folds.

BACKGROUND: With the baby boomer generation firmly ensconced in middle age and the ubiquity of botulinum toxin type A, nonsurgical facial rejuvenation is becoming increasingly prevalent. As this generation continues to age, products with greater therapeutic power to correct aging changes will be in growing demand. METHODS: A multicenter, double-blind, randomized, within-subject, controlled study was conducted comparing Juvéderm Ultra Plus hyaluronic acid filler with bovine collagen. A subset of subjects classified as having treatment for severe nasolabial folds is presented in this article. Subjects received Juvéderm Ultra Plus in one severe nasolabial fold and Zyplast collagen in the other nasolabial fold; up to two touch-up treatments were allowed at 2-week intervals. Nasolabial fold severity was evaluated every 4 weeks for 24 weeks using a five-point scale. Treatment site reactions and adverse events were also recorded. A complimentary treatment was offered at the end of the trial, with effectiveness evaluations just before retreatment and up to 48 weeks after repeated treatment for a subset of subjects. RESULTS: Of the 87 subjects, most were female Caucasians, but all Fitzpatrick skin types were represented (36 percent types IV through VI). At 24 weeks, 96 percent of nasolabial folds treated with Juvéderm had maintained clinically significant correction, and 81 percent maintained the correction for 1 year or more. Results were similar for those subjects with follow-up through 48 weeks after repeated treatment. The median volume required for repeated treatment with Juvéderm was significantly less than that for initial treatment (0.7 ml versus 1.6 ml). CONCLUSION: Juvéderm Ultra Plus provides correction of severe nasolabial folds through 1 year or more.

A randomized, multicenter study of the safety and efficacy of Dermicol-P35 and non-animal-stabilized hyaluronic acid gel for the correction of nasolabial folds.

BACKGROUND: Non-animal-stabilized hyaluronic acid (NASHA) offers longer-lasting cosmetic improvement and reduced risk of hypersensitivity and requires less injection volume than bovine collagen-derived dermal fillers. Porcine collagen-derived Dermicol-P35 has low immunogenicity and has the potential to provide durability at least equivalent to that of NASHA. OBJECTIVE: The objective was to evaluate the efficacy and safety of Dermicol-P35 and NASHA for correction of nasolabial folds (NLFs). METHODS AND MATERIALS: A total of 149 subjects with moderate NLFs were randomized to receive Dermicol-P35 and NASHA on contralateral sides of the face. If needed, subjects could receive a repeat injection 2 weeks later to obtain an optimal cosmetic result (OCR). RESULTS: Significant (p<.001) improvement in the Modified Fitzpatrick Wrinkle Scale scores relative to screening was observed after treatment with Dermicol-P35 and NASHA. Relative to the OCR visit, mean scores increased (p<.001) over time, but there were no significant differences between treatments (+0.39 and +0.37 at 6 months; p=.626). Greater proportions of subjects experienced swelling, bruising, and pain at the NASHA site. Several subjects had more induration at the Dermicol-P35 site. There was no evidence of any adverse immunologic effect. CONCLUSION: The effectiveness of Dermicol-P35 is maintained for at least 6 months and is equivalent to NASHA for the correction of NLFs.

Stress reactivity and coping in seasonal and nonseasonal depression.

Stress, stress reactivity, and coping skill use were examined in individuals with seasonal depression, nonseasonal depression, and nondepressed controls. Although participants in the two depressed groups reported using more avoidance coping strategies than controls, only participants in the seasonal depressed group reported using more season-specific coping (i.e., light-related strategies) than participants in the nonseasonal depressed and control groups. Individuals in the seasonal depressed group also reporting using acceptance coping strategies less frequently than individuals in the control group. Only participants in the nonseasonal depressed group, however, exhibited greater psychophysiological arousal in reaction to a laboratory stressor (i.e., unsolvable anagram task) when compared to participants in the seasonal and nondepressed control groups. Participants in both depressed groups reported greater impact of negative life events during the past 6 months than did controls. Similarities and differences in the two types of depression may have implications for the conceptualization and treatment of seasonal depression.