A Randomized, Evaluator-Blind, Split-Face Study Evaluating the Safety and Efficacy of Calcium Hydroxylapatite for Jawline Augmentation.

INTRODUCTION: Jawline augmentation with calcium hydroxylapatite has not yet been evaluated in a prospective study with a split-face design. This study aims to perform the first randomized controlled, split-face study on the efficacy and safety of calcium hydroxylapatite for jawline augmentation using the needle and cannula technique. OBJECTIVE: To perform the first randomized controlled, split-face study on the efficacy and safety of calcium hydroxylapatite for jawline augmentation using the needle and cannula technique. MATERIALS AND METHODS: This is a single-site, randomized, evaluator-blind trial enrolling a total of 10 healthy subjects with at least Grade 1 (mild) on a 4-point Jawline Scale. One side of the face was randomized to receive 1 to 2 syringes of calcium hydroxylapatite with lidocaine (total of 3 mL) for correction of wrinkles and folds along the jawline using both the cannula and needle method, and a balancing treatment will be performed 1 month later. Blinded investigator and subject evaluations will be performed immediately after treatment and at the 30-, 60-, and 90-day visits. RESULTS: Ten subjects were enrolled and completed the trial. There was a improvement in the degree of wrinkling and skin sagging in the 4-point Jawline Scale, with an average of a 1.3-point improvement in the scale on the day of treatment and at the Day 30 visit, which remained improved greater than baseline after 3 months as graded by blinded investigators. The Clinician Global Aesthetic Improvement Score for the treated side versus control, as assessed by blinded investigators, demonstrated a improvement with a 2.3-point improvement on the 5-point scale, and by the final visit on Day 90, most patients had a much improved appearance from baseline. CONCLUSION: This study demonstrates that calcium hydroxylapatite is effective and safe for restoration and augmentation of the jawline using the unique needle and cannula technique.

Prospective Clinical Trial Evaluating the Long-Term Safety and Efficacy of Calcium Hydroxylapatite for Chest Rejuvenation.

BACKGROUND: Calcium hydroxylapatite (CaHA) is indicated for correcting moderate-to-severe facial wrinkles and folds. Hyperdilute CaHA is increasingly being used for stimulating neocollagenesis to improve skin quality and firmness. OBJECTIVE: This study assessed long-term effects of hyperdilute CaHA for improving chest wrinkle appearance. METHODS AND MATERIALS: Adult female subjects (N=20) were treated with a 1:2 dilution of CaHA and evaluated at week 6, week 12, day 180, and day 360 using validated Merz Décolletage Scales. A Subject Satisfaction Questionnaire was used to assess overall satisfaction on a scale from 0 (Completely Dissatisfied) to 6 (Completely Satisfied). RESULTS: Subjects achieved significant improvements in baseline Merz Décolletage Scale–Dynamic scores at week 6, after a single treatment (P=0.02), at week 12 (two treatments) (P=0.01), day 180 (P=0.01), and day 360 (P<0.01). Subjects also demonstrated significant improvement in baseline Merz Décolletage Scale–At Rest scores at week 6 (P<0.01), remaining significant at week 12 (P<0.01), day 180 (P<0.01), and day 360 (P<0.01). Subject Satisfaction scores increased from 3.25 at day 180 to 3.59 at day 360 using a 7-point scale. CONCLUSION: Hyperdilute CaHA significantly improves the dynamic and resting appearance of wrinkles of the décolleté. These durable improvements persist for at least 1 year. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5680.

Prospective Clinical Trial of the Latest Generation of Noninvasive Monopolar Radiofrequency for the Treatment of Facial and Upper Neck Skin Laxity.

BACKGROUND: Aging of the face and upper neck is a complex process characterized by loss of collagen and elastic fibers, resulting in clinical skin laxity. Noninvasive interventions such as monopolar capacitively coupled radiofrequency (MRF) have gained popularity, offering a safer and more convenient alternative to traditional surgical face lift. The latest MRF device features larger tips, vibration, cooling, and impedance matching. OBJECTIVE: We performed the first open-label clinical trial, measuring the efficacy, safety, and patient satisfaction of this device for noninvasive lifting and tightening of the face and upper neck. MATERIALS AND METHODS: Forty subjects 30 to 60 years of age with mild/moderate skin laxity of the face and upper neck were enrolled. After pretreatment with ketorolac 60 mg intramuscular injection, subjects underwent treatment with MRF. Follow-up evaluations were performed on Days 30, 60, and 180. RESULTS: Our study demonstrated that the newest generation MRF produced statistically significant improvement in skin laxity 6 months post-treatment, especially in the jowls and melolabial folds. According to the Investigator Global Aesthetic Improvement Score, 73% of subjects had improvement at 6 months post-treatment. Subject satisfaction and improvement questionnaires supported these findings. CONCLUSION: Our data coupled with the excellent adverse effect profile validates MRF as an attractive treatment modality for facial and upper neck skin laxity.

A Prospective Double-blind, Placebo-controlled Clinical Trial Evaluating the Efficacy of a Novel Combination of Hyaluronic Acid Serum and Antioxidant Cream for Rejuvenation of the Aging Neck.

BACKGROUND: The neck is one of the most common areas affected by the aging process. A novel two product combination system composed of a serum and cream with hyaluronic acid and multiple strong antioxidants were investigated to determine their efficacy and safety in neck rejuvenation. OBJECTIVE: The objective of this prospective, randomized, double-blind, placebo-controlled clinical trial was to assess the efficacy and safety of a novel serum containing fractionated hyaluronic acid, peptides, and antioxidants for photodamage of the neck. METHODS: This was an institutional review board (IRB)-approved, randomized, double blind, placebo-controlled clinical trial involving 31 healthy subjects with moderate-to-severe neck wrinkling corresponding to at least a Grade 2 in wrinkles and score of 4 in elastosis on the Fitzpatrick-Goldman Wrinkle Scale. Twenty subjects were randomized to receive the active cream and serum system, while 11 subjects were randomized to receive the vehicles alone in serum and cream format for a course of two months. RESULTS: Both active and placebo cream and serum showed improvement of wrinkles, laxity, pigmentation, erythema, dryness, and texture of the skin, and high patient satisfaction scores. Histology of one of the active serums and cream samples revealed improvement in the quality of papillary dermal collagen and increase in the number of elastic fibers in the upper dermis after treatment. CONCLUSION: Our prospective, randomized controlled trial showed that the novel serum and cream showed improvement in skin aging on the neck, was well-tolerated by patients, and had a high degree of patient satisfaction.

Red Deer Umbilical Cord-Derived Stem Cell Conditioned Media Combined With Ablative Resurfacing of the Face.

BACKGROUND: Laser resurfacing is the gold standard procedure for photodamage, but is not without downtime and risk. Use of periprocedural products containing stem cell conditioned media may improve results and optimize healing. STUDY DESIGN: This was a prospective, randomized controlled, double-blind study, evaluating the efficacy and tolerability of red deer umbilical cord-derived stem cell conditioned media (USCCM) cream and serum pre- and post- ablative facial resurfacing. METHODS AND MATERIALS: Twenty patients with moderate to severe photodamage were randomized to receive vehicle or USCCM cream and serum pre- and post- ablative resurfacing of the face. Blinded investigators rated healing, tolerability, and efficacy, while subjects rated post-procedure symptoms, tolerability, and satisfaction. RESULTS: Both the active and vehicle pre-procedure cream were soothing, calming and easy to use by all patients. There was a trend towards decreased facial erythema and crusting in the active versus vehicle group. A greater improvement in wrinkling occurred in the active group. The majority of subjects were very satisfied with the active products. There were no serious adverse events. CONCLUSION: Red deer umbilical cord-derived stem cell conditioned media (USCCM) is well tolerated, safe and efficacious for use pre- and post- facial laser resurfacing.J Drugs Dermatol. 2020;19(11): 1044-1048 doi:10.36849/JDD.2020.5246.

Clinical Trial Evaluating the Long-Term Efficacy of Microfocused Ultrasound With Visualization for Décolleté Rejuvenation.

Previous studies have demonstrated the beneficial effects of microfocused ultrasound with visualization (MFU-V) for treating chest wrinkles; however, those studies followed subjects for only 180 days. The objective of the following study was to assess the long-term effects of MFU-V for the treating chest wrinkles. Each subject was treated with 4-4.5 mm, 7-3.0 mm, and 10-1.5 mm transducers. Subjects were subsequently evaluated on post-treatment days 6, 12, 180, and 360. Digital images were obtained of the décolleté area of each subject prior to treatment and at each follow-up evaluation. Wrinkle severity was assessed using the validated Merz Décolletage Wrinkle Scales at each follow-up visit and Subject Satisfaction Questionnaires were completed on post-treatment days 180 and 360. Enrolled subjects (N=20) were female with a mean (SD) age of 54.9 (7.5) years (range, 44 to 71 years). The study was completed by 15 subjects. Subjects achieved a significant decrease in dynamic wrinkle scores over time (P<0.01). Baseline scores were significantly decreased at day 90 (P≤0.01) which remained significant at days 180 and 360 (for each, P<0.01). Subjects also showed significantly decreased at-rest wrinkle scores over time (P≤0.01). Baseline scores were significantly decreased at day 90 (P≤0.01), which remained significant at days 180 and 360 (for each, P=0.01). Mean (SD) subject satisfaction scores increased from 2.9 (1.8) on day 180 to 3.9 (1.8) on day 360.J Drugs Dermatol. 2020;19(11):1026-1029. doi:10.36849/JDD.2020.5265.

Comparison of the Safety and Efficacy of Foam Sclerotherapy With 1: 2 Polidocanol to Air Ratio Versus 1: 4 Ratio for the Treatment of Reticular Veins of the Lower Extremities.

BACKGROUND: Foam sclerotherapy is a common treatment of lower extremity reticular veins. The effect of different liquid-gas ratios on foam stability and efficacy has been controversial. OBJECTIVE: To evaluate the use of 2 different polidocanol (POL) to air ratios for the treatment of reticular veins of the lower extremities. METHODS AND MATERIALS: Patients with lower extremity reticular veins were randomized to foam sclerotherapy with POL mixed with 4 mL of room air for one lower extremity or 2 mL for the other lower extremity. All telangiectasias were treated with glycerin immediately after treatment of the reticular veins. Adverse events (AEs) and efficacy were evaluated by both subject and blinded investigator. RESULTS: Thirty subjects completed the study. No statistically significant difference was seen in AEs between the 2 different POL to air ratios by subject questionnaire and blinded investigator scores at all time points. Subjects and blinded investigator reported a mean improvement between 0% and 50% at Day 21 and 26% to 75% at Day 90, which was not significantly different between groups. CONCLUSION: Two different POL to air ratios, 1:2 versus 1:4, were similarly safe and efficacious for the treatment reticular veins of the lower extremities.

A Randomized, Split-Body, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Poly-L-lactic Acid for the Treatment of Upper Knee Skin Laxity.

BACKGROUND: Skin laxity of the upper knee and lower thigh is a common complaint among patients. OBJECTIVE: This is a randomized, double-blinded, split-body, placebo-controlled study to evaluate the safety and efficacy of poly-L-lactic acid (PLLA) for treatment of upper knee skin laxity. MATERIALS AND METHODS: Twenty female subjects between the ages of 30 and 65 years with upper knee laxity were enrolled. The patients were randomized to receive 3 treatments of PLLA in 1 knee, whereas the other knee received 3 treatments of bacteriostatic water. RESULTS: Statistically significant improvement as rated on the physician global aesthetic improvement scale was seen at Day 56 after final treatment in the active knee when compared with the placebo knee. This improvement was sustained at Day 84 and Day 168 after final treatment visits. No statistically significant difference was seen between the active and placebo knees on the subject global aesthetic score or the subject satisfaction scale. CONCLUSION: Based on our study, PLLA may be a safe and effective modality in addressing upper knee skin laxity. Larger studies with longer follow-up times and a validated knee laxity scale are needed to further determine if and how much improvement can be achieved.

Suture Lifting: A Review of the Literature and Our Experiences.

BACKGROUND: In the past 5 years, several absorbable sutures for use in minimally invasive suture lifts have appeared on the market. These newer sutures were preceded by several iterations of nonabsorbable counterparts, all of which were eventually removed from the market because of complications. OBJECTIVE: This review will provide a history of suture lift experience, review the published evidence on the safety and efficacy of currently available absorbable suture lift materials, and detail the clinical experience of the authors using these products. MATERIALS AND METHODS: A review of relevant clinical terms was performed on PUBMED and MEDLINE databases. All articles were reviewed, and further studies examined from citations of selected articles. Articles that focused on suture lifting using extensive dissection were excluded. RESULTS: Twelve studies detailed the results of absorbable suture lifting largely through patient satisfaction surveys or retrospective chart review of cases. No randomized controlled studies were available. CONCLUSION: Data on suture lifting are limited, with largely descriptive and retrospective case reports available in the literature entailed Oxford Centre evidence-based medicine Levels 2a to 5. Based on the available data, suture lifting appears to be safe and well tolerated, with patient satisfaction similar to or above that reported for other noninvasive lifting and tightening procedures. However, due to the lack of randomized controlled trials, the authors give the suture lifting Strength of Recommendation Level C. Further controlled studies are necessary to determine efficacy, longevity, and safety of this technology.

The Efficacy of Pulsed Dye Laser Pretreated With or Without Local Anesthetic on Patients Presenting With Erythema of Face, Neck, Chest, and Extremities.

BACKGROUND AND OBJECTIVES: Erythema is one of the most common cosmetic concerns and usually responds well to pulsed dye laser (PDL) treatment. As this laser can cause significant discomfort, topical anesthesia is sometimes offered. However, it is still uncertain whether topical anesthetics can affect the outcome of the laser therapy. We performed a retrospective single site study to compare the efficacy of PDL for the treatment of erythema in patients with and without pretreatment with topical anesthetic. STUDY DESIGN/MATERIALS AND METHODS: A chart review was performed and patients who presented with erythema of face, neck, chest, and extremities pretreated with topical anesthesia (23% lidocaine/7% tetracaine ointment or 7% lidocaine/7% tetracaine ointment) undergoing PDL were reviewed and compared with another group without anesthesia. Two blinded dermatologists evaluated the postlaser procedure photographs and gave an assessment compared with baseline. RESULTS: A total of 69 patient charts were reviewed. The erythema resulted from various skin conditions including telangiectasia, cherry angioma, striae, and rosacea. The mean improvement was 2.2581 in the anesthesia group and 2.2632 in the nonanesthesia group. There was no significant difference between both groups as confirmed by a noninferiority test. CONCLUSIONS: Topical anesthesia with lidocaine and tetracaine ointment do not interfere with the efficacy of the PDL. Since pain management is essential for any cosmetic procedure, the application of a local anesthetic will enhance patient comfort and satisfaction during treatment with PDL. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

Red Deer Umbilical Cord Lining Mesenchymal Stem Cell Extract Cream for Rejuvenation of the Face

Background: Aging is a multifactorial process that involves all components of the skin. Both intrinsic and extrinsic forces play a role in this aging process. A new patented protein mix derived from red deer umbilical cord lining stem cell conditioned media (Calecim® Multi Action Cream, CellResearch Corporation, Singapore) has been developed to improve the signs of aging. The extract is the conditioned media from umbilical cord lining mesenchymal stem cell culture in basal media and consists of a mixture, in specific proportions, of cytokines, growth factors, extracellular matrix proteins, amino acids, peptides, and other proteins. It has been developed to increase epidermal cell turnover and stimulate fibroblast function, reducing the appearance of pigmentation, fine lines, and redness, and to restore skin elasticity. Objective: The objective of this IRB-approved, prospective, randomized, double-blind, split-face, placebo-controlled clinical trial was to compare the efficacy of red deer mesenchymal stem cell extract (RCE) versus vehicle for facial rejuvenation. Methods: The trial involved 40 healthy subjects with moderate to severe facial wrinkling secondary to photodamage. One half of the face was randomized to receive topical RCE cream and vehicle cream to the other half of the face. Treatment was continued for 3 months, and evaluations were performed in a double-blind fashion. Results: Both sides of the face achieved significant improvement. Blinded investigator assessments did not detect any statistically significant differences between the two halves of the face in terms of efficacy, safety, or tolerability. Subject evaluations demonstrated superiority of the active treatment side. Conclusion: Red deer umbilical cord lining mesenchymal stem cell extract was effective in rejuvenating the aging face as demonstrated by investigator and subject measures. J Drugs Dermatol. 2019;18(4):363-366.

A Randomized, Split-Face, Evaluator-Blind Clinical Trial Comparing Monopolar Radiofrequency Versus Microfocused Ultrasound With Visualization for Lifting and Tightening of the Face and Upper Neck.

BACKGROUND: Over the past decade, 2 major modalities for noninvasive skin tightening have emerged: monopolar capacitive-coupled radiofrequency (MRF) and microfocused ultrasound with visualization (MFU-V). Up to date, no comparative clinical trials have been performed. OBJECTIVE: To compare the efficacy and safety of MRF versus MFU-V for the lifting and tightening of the face and neck. MATERIALS AND METHODS: Twenty subjects with mild to moderate skin laxity received MFU-V over one-side of the face and MRF over the other side of the face at the same time. Subjects were followed for 6 months. RESULTS: Both MRF and MFU-V led to a decrease in the Fasil Face and Neck Laxity Grading Scale (FLR). These differences became significant at Day 30 and remained significantly improved through Days 90 and 180 in both groups. There was no statistically significant difference in the FLR Scale between MRF-treated and MFU-V-treated sides. Subjects' Global Aesthetic Improvement Scale showed improvement at Day 30, 90, and 180. CONCLUSION: Both MRF and MFU-V led to significant improvement in face and neck laxity. There were no statistical differences between MRF and MFU-V in standardized investigator measures of face and neck laxity, patient satisfaction, and adverse events.

A Single Site, Open Label Clinical Trial, Evaluating the Duration, Efficacy, and Safety of a Novel Lip Plumper.

INTRODUCTION: Lip plumpers are topical agents that offer immediate, but temporary, volumization of the lips. While these products are becoming increasingly popular and are available at multiple retailers, there is a lack of clinical studies to evaluate the efficacy, longevity, and safety of the lip plumping products. METHODS: This is a prospective, single center, clinical trial to evaluate the duration, efficacy, and safety of a lip plumping agent in two clinical visits. Lip volume and adverse event were assessed by two clinicians at various time points: 15 minutes, 1 hour, 2 hours, 3 hours, and 4 hours. RESULTS: Twenty-two subjects were enrolled in the study, and eighteen completed the study. Investigator assessments of global improvement 15 minutes after application of the lip plumping product demonstrated improvement in lip fullness in 100% of the subjects (18/18), and 1 hour post-application 67% (12/18) showed an improvement in lip fullness that was statistically significant compared to the 2-hour assessment (P less than 0.05). Subject evaluations noted improvement in lip fullness 15 minutes post-application in 94.4% (17/18) of subjects, and 1 hour post-application, 89% (16/18) of the subjects who completed the trial noted some improvement in the volume of their lips that was statistically significant compared to the 2-hour post-application time point (P less than 0.0001). Subjects noted that they did experience a tingling and heat sensation, but a majority noted that that this sensation lasted less than 15 minutes. DISCUSSION: Our study demonstrated that the lip plumping product increased lip volume in almost all patients 15 minutes post-application and showed a continued improvement in lip fullness per investigator assessments 1 hour after application. Adverse events of a tingling or heat sensation were expected and observed as the topical product contained capsaicin, cinnamon, and menthol, all of which can induce this sensation by the release of substance P. J Drugs Dermatol. 2018;17(9):999-1004.

Association Between Surgeon-Specific Features and Number of Stages, Flaps, and Grafts in Mohs Micrographic Surgery: A Retrospective Observational Study of 59 Early-, Mid-, and Advanced-Career Mohs Surgeons.

BACKGROUND: There is limited data available to correlate Mohs surgeons' behavior and years of experience. Moreover, the recent standardization of Mohs surgery training programs may allow for the prediction of future trends in Mohs micrographic surgery surgery based on the current behavior of recently trained Mohs surgeons. OBJECTIVE: To better understand the relationship between surgeon-specific characteristics and the number of Mohs micrographic surgery total cases, stages per case, number of grafts, and number of flaps performed by each surgeon. MATERIALS AND METHODS: Procedure data of 59 early-career, mid-career, and advanced-career Mohs surgeons were obtained from the website of the Centers for Medicare & Medicaid services. RESULTS: No statistically significant differences were identified in the number of stages per case between the 3 groups. Two-proportion testing between advanced-career surgeons and early-career surgeons indicated a statistically significant difference in the number of surgeons performing flaps or grafts (p < .05). Similarly, a statistically significant difference was noticed between mid-career surgeons and early-career surgeons (p < .05). CONCLUSION: The result of this study showed that more years of experience was significantly associated with reported utilization of flaps or grafts in practice. Furthermore, no significant difference was observed between years in practice and number of stages per case.

Comparison of the efficacy of biologics versus conventional systemic therapies in the treatment of psoriasis at a comprehensive psoriasis care center.

BACKGROUND: The efficacy of biologic treatment for psoriasis has not been compared to that of conventional systemic therapies and phototherapy outside of clinical trial settings. DESIGN: Retrospective, cross-sectional. METHODS: All patient visits with a code for psoriasis (ICD-9 696.1) in the clinical practice of two dermatologists with a high percentage (over 70% of chief complaints) of psoriasis patients from Jan 1, 2008 to Jan 4, 2012 inclusive were included in this retrospective data analysis. Patients were excluded if the baseline Physician's Global Assessment (PGA) at start of treatment was unknown, or less than 3 (moderate). The practice is a comprehensive psoriasis care center in the Northeastern United States serving a metropolitan population of over 4 million people. Patients were divided by treatment type (biologic, conventional systemic or both) and history of previous treatments. Patients were evaluated by Body Surface Area (BSA), PGA, Simple-Measure for Assessing Psoriasis Activity (S-MAPA, calculated by BSA multiplied by PGA). Patients were evaluated at baseline, 8, 12, 16, and 24 weeks after start of treatment. Patients must have completed at least 8 weeks on a single treatment in order to be included. RESULTS: 46 courses of biologics, 12 courses of conventional systemic therapies, and 18 courses of both together were identified with PGA 3 or greater at baseline. Baseline S-MAPA for biologics was 74, for non-biologic systemics was 62.25. At week 24, S-MAPA improved 70.2% over baseline in patients treated with biologics, patients treated with non-biologic systemics improved by only 40.4% (P<0.05). The average number of prior treatments for patients on biologics was 1.87 versus 1.25 for patients on conventional systemic therapies (P=0.169). CONCLUSION: Biologics show superior results to conventional systemic therapies (70% improvement versus 40% improvement) for the treatment of patients with moderate to severe psoriasis, as measured by decrease in S-MAPA (PGA multiplied by BSA) at week 24. These results were observed despite the fact that patients on biologics had a greater baseline severity and had a greater number of previous treatments.