Abstracts

A summary of the latest clinical studies

Title: A Double-Blind, Placebo-Controlled, Phase 3b Study of ATX-101 for Reduction of Mild or Extreme Submental Fat Authors: Glogau RG, Glaser DA, et al. Published: Dermatologic Surgery, April 2019 Keywords: Fat dissolving, ATX-101, deoxycholic acid Abstract: Objective: to evaluate the efficacy and safety of ATX-101 in subjects with mild or mild or extreme submental fat (SMF). Adults with mild or extreme SMF (based on clinician assessment) were randomized to receive ≤6 treatments with ATX-101 or placebo. Efficacy end points, evaluated at 12 weeks after last treatment, included percentage of subjects who achieved ≥1-grade improvement in SMF from baseline based on both clinician and patient assessment (composite CR-1/PR-1 response) as well as multiple subject-reported outcomes. Safety end points included change in skin laxity and incidence of adverse events. Overall, 61.3% of ATX-101-treated subjects versus 6.7% of placebo-treated subjects with mild SMF and 89.3% versus 13.3% of subjects, respectively, with extreme SMF achieved a composite CR-1/PR-1 response (p < .001 for both). ATX-101-treated subjects also reported higher levels of satisfaction and greater reductions in the psychological impact of SMF versus placebo-treated subjects regardless of baseline SMF severity. Skin laxity was unchanged or improved in most of the subjects. Adverse events were mainly mild/moderate, transient, and associated with the injection site. ATX-101 was efficacious and well tolerated for reduction of mild or extreme SMF.

Title: Red Deer Umbilical Cord Lining Mesenchymal Stem Cell Extract Cream for Rejuvenation of the Face Authors: Alhaddad M, Boen M, et al. Published: Journal of Drugs in Dermatology, April 2019 Keywords: Stem cell, facial rejuvenation, ageing Abstract: 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. 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. 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 three months, and evaluations were performed in a double-blind fashion. 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. Red deer umbilical cord lining mesenchymal stem cell extract was effective in rejuvenating the aging face as demonstrated by investigator and subject measures.

Title: Hyperbaric Oxygen Therapy for Dermal Ischemia after Dermal Filler Injection with Calcium Hydroxylapatite Authors: Uittenbogaard D, Lansdorp CA, et al. Published: Journal of the Undersea and Hyperbaric Medical Society, May 2019 Keywords: Dermal filler, complications, vascular occlusion Abstract: One of the most threatening complications after dermal filler injection is skin necrosis due to vascular occlusion. Different treatment options are available, including the use of hyperbaric oxygen (HBO2) therapy. A 46-year-old female received facial dermal filler injections with calcium hydroxylapatite at an aesthetic clinic. A few days after injection she developed a burning pain, numbness of the skin and white discoloration in the injected area. Two days after injection treatment was started with hyaluronidase and warm compresses. In addition, the patient received prednisolone, sildenafil and nifedipine. After the start of these treatments, the pain, numbness and discoloration of the skin persisted. Because of dermal ischemia and to improve healing she was referred for HBO2. Treatment consisted of 10 sessions of 100% oxygen for 90 minutes in a multiplace chamber at 2.5 atmospheres absolute pressure. During HBO2 the discoloration resolved, pain and numbness disappeared, and the tissue healed completely. After a six-month follow-up she had an excellent cosmetic outcome. Given the pathophysiologic mechanisms of vascular complications after dermal filler injection, HBO2 should be considered when treating these complications.

Title: Evaluation Of Platelet-rich Plasma vs Intralesional Steroid in Treatment of Alopecia Areata Authors: Albalat W, Ebrahim H M Published: Journal of Cosmetic Dermatology, May 2019 Keywords: PRP, alopecia, hair loss Abstract: Objective: to evaluate the safety and efficacy of Platelet-rich plasma (PRP) vs intralesional corticosteroid (ILCs) in treatment of Alopecia areata (AA). This study was conducted on 80 patients of both sexes who had AA. Patients were classified into Group I treated by ILCs and group II treated by PRP. Results were assessed by dermoscopic evaluation and by hair re-growth score (RGS) at (baseline), 2, 4, 6, 8, and 12 weeks. Patients were followed up for 6 months. There was greater hair re-growth after treatment in both groups. In group I, (26) patients (65%) showed improvement >70% compared to 29 patients (72.5%) in group II. There was significant re-growth of pigmented hair and decrease in dystrophic hair (P < 0.001) by dermoscopic evaluation in both groups. The difference between both groups was insignificant (P = 0.57). At follow-up, two (5%) patients in group II had relapse compared to 10 (25%) patients in group I. PRP is a safe and promising therapeutic option in AA.