A Clinical Histology Study Evaluating the Biostimulatory Activity Longevity of Injectable Poly-L-Lactic Acid for Facial Rejuvenation.

BACKGROUND: Poly-L-lactic acid (PLLA) is an injectable filler used for restoring facial fat volume loss that improves skin quality. OBJECTIVE: To evaluate the histological changes underlying the observed improvement in skin quality after repeated PLLA injections. METHODS: Ten healthy women were enrolled in this randomized, placebo-controlled, single-center study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections, into both sides of the face. Follow-up visits were at week 18 after the last treatment. Assessments included live ratings, patient questionnaires, three-dimensional microtopography imaging analysis, and histological analysis from biopsies taken before and after PLLA treatment. RESULTS: At the 18-week follow-up, there was a significant improvement in investigator- and subject-rated global aesthetic improvement (GAIS) scores, as well as a decrease in wrinkle severity in PLLA-treated but not placebo-treated patients. Skin quality parameters of erythema, pore size, and roughness were significantly improved from baseline and compared with placebo at the 18-week follow-up as assessed by microtopographic analysis and investigator ratings. Histologic analysis revealed increased tissue remodeling and angiogenesis in PLLA-treated tissues at the 18-week follow-up and decreased elastin fragmentation compared with baseline. No treatment-related adverse events occurred. CONCLUSION: Repeated PLLA treatments may improve skin quality through tissue remodeling and neovascularization. J Drugs Dermatol. 2024;23(9):729-734. doi:10.36849/JDD.8057.

Combination therapy in female pattern hair loss.

Patterned hair loss is a common type of non-scarring alopecia, characterized by miniaturization of hair follicles. The etiology of female pattern hair loss (FPHL) is not clearly linked to androgens or other hormones thereby making it a challenging condition to treat. Various treatment modalities, like minoxidil (topical or oral), spironolactone, finasteride, have been tried alone or in combination with variable results. Combination therapy is superior to the monotherapy, since these multiple treatment modalities act by targeting different pathogenetic pathways, making the treatment aggressive and more effective.

Best Clinical Practices with ATX-101 for Submental Fat Reduction: Patient-related Factors and Physician Considerations.

BACKGROUND: Submental fat can be reduced with ATX-101 (deoxycholic acid injection), a customizable and minimally invasive alternative to liposuction. In the years since its approval, the treatment patterns of ATX-101 have evolved. METHODS: A panel of experienced physicians from the United States gathered to generate best practices for the use of ATX-101 in submental contouring. RESULTS: The expert panel provided their insights on appropriate patient selection, managing patient expectations of ATX-101 treatment outcomes, and adverse events, and guidance on ATX-101 administration for optimal outcomes are presented here. CONCLUSION: These best clinical practices on the use of ATX-101 for the reduction of submental fat should enable physicians to enhance the patient treatment experience and outcomes.

Development and Validation Clinician and Patient Reported Photonumeric Scales to Assess Buttocks Cellulite Severity.

BACKGROUND: The Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported PCSS (PR-PCSS) are newly developed tools for assessing cellulite severity. OBJECTIVE: To report on the reliability, validity, and ability to detect a change in cellulite severity on the buttocks of adult women with the CR-PCSS and PR-PCSS. MATERIALS AND METHODS: Content validity of both scales was established through concept elicitation and cognitive interviews. Test-retest reliability was evaluated, and intra-rater (both scales) and inter-rater (CR-PCSS only) reliability were estimated using intraclass correlation coefficients (ICCs) for agreement and consistency. Ability to detect a change was determined using the Subject-Global Aesthetic Improvement Scale (GAIS) or Investigator-GAIS as anchors. RESULTS: For the CR-PCSS (n = 6) at baseline and Day 2, the mean interrater ICCs were ≥0.70 and mean intrarater ICCs (95% confidence interval [CI]) were ≥0.81 (0.72-0.90) for both buttocks. For the PR-PCSS (n = 99) at baseline and Day 14, the mean test-retest reliability ICCs (95% CI) were ≥0.86 (0.79-0.91) for both buttocks. A clinically meaningful change was 1.0 point on the PR-PCSS and 1.0 on the CR-PCSS. CONCLUSION: The CR-PCSS and PR-PCSS reliably assess cellulite severity of the buttocks and can detect a clinically meaningful change after treatment for cellulite.

Facial rejuvenation using Er:YAG laser equipped with a spatially modulated ablation module: A clinical, ultrasound, and histological evaluation.

BACKGROUND: A plethora of noninvasive approaches has been developed in recent years for facial rejuvenation. Energy-based devices have been one of the most popular treatments for reversing and preventing signs of facial aging such as fine lines, wrinkles, ptosis, and photoaging. AIMS: A new technology (RecoSMA) for skin rejuvenation based on acoustic-interference method using Er:YAG laser (2936 nm) equipped with a special module that targets both the dermis and the superficial musculoaponeurotic system (SMAS) was recently demonstrated to be safe and effective in facial rejuvenation. PATIENT/METHODS: In this follow-up prospective study, the clinical effects of recoSMA treatment on skin structures and SMAS were evaluated with ultrasound and histological analysis, at 30 and 90 days posttreatment. RESULTS: Treatment with recoSMA was shown to result in a significant increase in thickness of the epidermis, dermis, and SMAS layer, while levels of collagen I, III, and IV were shown to be elevated at 90 days posttreatment. CONCLUSION: Collectively, data show that treatment with recoSMA laser has a profound biological effect in stimulating and reconstructing the elastin/collagen framework necessary for preventing facial aging.

Effective noninvasive body contouring by using a combination of cryolipolysis, injection lipolysis, and shock waves.

BACKGROUND: Cryolipolysis combined with shockwave therapy has been previously shown to have synergistic effects in body contouring results. OBJECTIVE: This open-label, prospective, multicenter, comparative study investigated the safety and efficacy of combined cryolipolysis, shockwave therapy with cryolipolysis, shockwave therapy, and injection polyenylphosphatidylcholine-based lipolysis. METHODS: Enrolled patients were treated in the abdominal or flank area with cryolipolysis, shockwave therapy and injection lipolysis (n = 10) or cryolipolysis and shockwave therapy (n = 4). All treatments were conducted the same day. Evaluations were conducted 3 months after treatment and included histological analysis, standardized photography, blinded-investigator efficacy, and safety ratings, as well as patient ratings of satisfaction and tolerance. RESULTS: Compared to baseline, the 3-month follow-up histological analysis revealed a more profound subcutaneous adipose tissue reaction with the triple combination therapy (cryolipolysis, injection lipolysis, radial shock wave) than with the double combination with regard to adipocyte damage and grade of inflammation. Waist circumference was significantly reduced in patients of both groups, but patients in the triple combination group were shown to have a significantly more pronounced reduction in subcutaneous fat. Factors that were shown to influence treatment outcome included baseline BMI and waist circumference. Age and gender had no effect. The abdominal area reacted better to the treatment compared to flanks. No significant side effects or adverse events were reported. The procedure was well-tolerated, and the majority of patients were satisfied with the treatment results. CONCLUSIONS: Combination of cryolipolysis, radial shockwave, and injection lipolysis is a safe, well-tolerated treatment for reduction in subcutaneous fat.

Collagenase Clostridium Histolyticum for the Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite): A Randomized Trial.

BACKGROUND: Edematous fibrosclerotic panniculopathy (EFP; cellulite) is associated with thickening and contraction of collagen-rich subdermal septae. Collagenase clostridium histolyticum (CCH) may disrupt collagen-rich septae. OBJECTIVE: To evaluate the safety and efficacy of CCH for treatment of EFP. MATERIALS AND METHODS: In a randomized, double-blind study, women with moderate or severe EFP of the buttocks or posterolateral thighs (i.e., Clinician Reported Photonumeric Cellulite Severity Scale [CR-PCSS] and Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] ratings of 3 to 4, and Hexsel Cellulite Severity Scale score ≤13) received up to 3 treatment sessions (Days 1, 22, and 43) of subcutaneous CCH 0.84 mg or placebo injections. End points included the percentage of 2-level and 1-level composite responders (i.e., had ≥2-level or ≥1-level improvement in CR-PCSS and PR-PCSS) at Day 71. RESULTS: Three hundred seventy-five women (mean age, 46.5 years; 86.4% white) were randomly assigned to CCH (n = 189) or placebo (n = 186). At Day 71, the percentages of 2-level and 1-level composite responders were greater with CCH (10.6% and 44.6%, respectively) versus placebo (1.6% and 17.9%; p < .001 for both). The most common adverse events were injection-site related. CONCLUSION: CCH significantly improved EFP appearance versus placebo; further evaluation of CCH for EFP (cellulite) is warranted.

Randomized, Controlled, Multicentered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid for Improving Skin Quality.

BACKGROUND: Poly-L-lactic acid (PLLA) is an injectable filler used for restoring facial fat volume loss. OBJECTIVE: To evaluate the effect of repeated PLLA injections on skin quality. METHODS: Forty healthy women were enrolled in this randomized, controlled, double-blind, multicenter study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections, into both sides of the face. Follow-up visits were at 6, 9, and 12 after the last treatment. Assessments included biophysical measuring instruments, live ratings, patient questionnaires, and rating of standardized pictures by a blinded evaluator. RESULTS: At the 12-month follow-up, there was a statistically significant increase of skin elasticity and hydration in PLLA-treated subjects and a decrease in transepidermal water loss in both groups. Pigmentation, erythema, and pore size were significantly decreased, whereas radiance and smoothness were significantly increased at 12 months per blinded investigator rating in this group. No treatment-related adverse events occurred. CONCLUSION: Repeated PLLA treatments may improve skin quality in a time-dependent manner.