Effective and durable repigmentation for stable vitiligo: A randomized within-subject controlled trial assessing treatment with autologous skin cell suspension transplantation.

BACKGROUND: Vitiligo lesions are often challenging to repigment with conventional medical therapies. Surgical autologous melanocyte transfer methods can be utilized for stable vitiligo but demand specialized skills and equipment. A point-of-care autologous cell harvesting device was designed enabling simple preparation of autologous skin cell suspension (ASCS) containing melanocytes, keratinocytes, and fibroblasts providing a straightforward approach for cellular transplantation. OBJECTIVE: To evaluate the safety and effectiveness of ASCS for repigmentation of stable vitiligo lesions among adults. METHODS: A US multicenter, randomized, within-subject controlled trial compared ASCS to narrow band ultraviolet B only (Control) in similar vitiligo lesions. ASCS was applied after laser skin resurfacing and followed by narrow band ultraviolet B treatment. The primary effectiveness endpoint was the proportion of lesions achieving ≥80% repigmentation at week-24. Repigmentation durability was assessed at week-52. RESULTS: Among 25 subjects, 36% of ASCS-treated lesions achieved ≥80% repigmentation at week-24 compared to 0% for Control (P < .025), with durability through week-52. The safety profile of ASCS was acceptable, with favorable patient- and investigator-reported outcomes. LIMITATIONS: Study sample size limited robust subgroup analyses. CONCLUSION: Application of ASCS has potential as a treatment for repigmentation of stable vitiligo lesions with the potential to improve health-related quality of life and reduce burden of disease.

Retrospective Review of the Laser Removal of Facial Cosmetic Tattoos.

BACKGROUND: Cosmetic facial tattoos have proven difficult to remove despite advancements in laser technology. OBJECTIVE: Review safety and efficacy of picosecond laser removal of cosmetic facial tattoos. METHODS MATERIALS: Retrospective chart review from January 2015 to January 2022 of patients undergoing tattoo removal of facial cosmetic tattoos. RESULT: A total of 33 patients were included in the review. The average number of treatments to obtain satisfactory results was 3. Sixty 6 percent of subjects were rated as "very much improved" with 76% to 100% of the tattoo removed and 34% of subjects were rated "much improved" with 51% to 75% of the tattoo removed. Thirty percent of subjects experienced unexpected changes in the tattoo color after initial treatment with 1,064-nm picosecond laser. CONCLUSION: Picosecond laser is an effective and safe treatment for cosmetic tattoos, and it highlights the underreported unmasking of an orange color postlaser treatment that can be successfully treated with a 532-nm PS laser.

Non-laser treatment for tattoo removal.

Tattoos are increasingly gathering attention in the young population, especially in second to fourth decade of life. With such trends, rate of its removal also has been on the rise. Treatment options for tattoo removal besides lasers are surgery, radiofrequency, infrared light, cryotherapy, dermabrasion and salabrasion. Unfortunately, none of these procedures are associated with satisfactory cosmetic results due to adverse effects such as scarring and dyspigmentation. Although laser treatment has become the gold standard for tattoo removal, it is also associated with some limitations. Some tattoo inks are resistant to laser, and multiple sessions and multiple wavelengths may be required for its complete removal. Considering these limitations, other treatment modalities for tattoo removal must be explored. This article highlights the non-laser treatment options for tattoo removal. We reviewed all published literature identified from electronic databases (MEDLINE and PubMed) till August 2021 to highlight the non-laser treatment options for tattoo removal.

A Novel Macrophage-Activating Gel Improves Healing and Skin Quality After CO2 Laser Resurfacing of the Chest.

BACKGROUND: After laser resurfacing, it is imperative that an appropriate postoperative regimen is followed for optimal wound healing. There is currently no consensus about which agents should be used. OBJECTIVE: To evaluate the safety and efficacy of a novel macrophage-activating gel in a Phase 2B trial to be used after fractionated ablative laser resurfacing of the chest. MATERIALS AND METHODS: Forty-two adults who received fractionated CO2 laser resurfacing of the chest were randomized (active or placebo) for 5 consecutive days after procedure. Skin quality at baseline and follow-up was assessed by a blinded evaluator using the Fitzpatrick-Goldman Wrinkle Scale. Subject satisfaction with skin healing and quality was also assessed. RESULTS: At 28 days according to the Fitzpatrick-Goldman Wrinkle Scale, 85% of subjects achieved an improvement of at least 33% for the active group versus 50% in the placebo group (absolute difference 35%; p = .04). Similarly, 75% of subjects achieved an improvement score of at least 33% in elastosis in the active group versus 35% in the placebo group at 28 days (40% absolute difference; p = .011). CONCLUSION: This study confirms the potent effects of the novel macrophage-activating gel for optimization of skin healing and quality after laser resurfacing of the chest.

Large Varicose Vein Closure: A Comprehensive Review.

BACKGROUND: Treatment of chronic venous disease and varicose veins has significant psychosocial and economic impact. The great saphenous vein is a common vein to develop incompetence and reflux and, therefore, been the focus of therapy for many years. OBJECTIVE: To review the published medical literature relating to large varicose vein closure and provide a guide for closure techniques' efficacy and safety. METHODS: A comprehensive search of the English language literature was performed up to and including December 2021. All references pertaining to large varicose vein closure were reviewed. RESULTS: There are multiple safe and effective minimally invasive methods to achieve occlusion of incompetent great saphenous vein, the most widely used of which is endovenous thermal ablation. Other nonthermal, tumescent, and nontumescent methods can also be used. CONCLUSION: Proper knowledge of vein anatomy, ultrasound, and vein closure procedures is needed to ensure safe and effective outcomes.

Sclerotherapy in Aesthetic Medicine: Myths and Realities.

BACKGROUND: Sclerotherapy is commonly performed for elimination of reticular and telangiectatic leg veins. There are several variations in practice, from the preparation to post-therapy directives. OBJECTIVE: To critically examine the misconceptions of sclerotherapy for aesthetic indications. MATERIALS AND METHODS: This review assesses evidence for and against each of the most common myths regarding sclerotherapy for aesthetic indications. RESULTS: Sclerotherapy can be safely used to treat veins in areas other than the lower extremities, with the exception of the face. Laser therapy is not superior to sclerotherapy for the treatment of small telangiectatic veins on the lower extremities. The type of syringe used to produce foam sclerotherapy is an important procedural consideration. After sclerotherapy, graduated compression stocking usage is a vital part of the procedure. Detergent sclerotherapy agents are similar, but not equivalent. Touch-up treatments after sclerotherapy should not be performed for 2 months post-treatment. Foam sclerotherapy does not have a high risk for air emboli. It is not advisable to treat the leg veins in "sections." Finally, one cannot reliably treat the telangiectatic veins without treating the feeding reticular veins for a satisfactory result. CONCLUSION: Many aspects of sclerotherapy have existing evidence to dictate best clinical practice.

Evidence-Based Clinical Practice Guidelines for Laser-Assisted Drug Delivery.

Importance: Laser-assisted drug delivery (LADD) is used for various medical and cosmetic applications. However, there is insufficient evidence-based guidance to assist clinicians performing LADD. Objective: To develop recommendations for the safe and effective use of LADD. Evidence Review: A systematic literature review of Cochrane Central Register of Controlled Trials, Embase, and MEDLINE was conducted in December 2019 to identify publications reporting research on LADD. A multidisciplinary panel was convened to draft recommendations informed by the systematic review; they were refined through 2 rounds of Delphi survey, 2 consensus meetings, and iterative review by all panelists until unanimous consensus was achieved. Findings: Of the 48 published studies of ablative fractional LADD that met inclusion criteria, 4 were cosmetic studies; 21, oncologic; and 23, medical (not cosmetic/oncologic), and 6 publications of nonablative fractional LADD were included at the request of the expert panel, producing a total of 54 studies. Thirty-four studies (63.0%) were deemed to have low risk of bias, 17 studies (31.5%) had moderate risk, and 3 (5.5%) had serious risk. The key findings that informed the guidelines developed by the expert panel were as follows: LADD is safe in adults and adolescents (≥12 years) with all Fitzpatrick skin types and in patients with immunosuppression; it is an effective treatment for actinic keratosis, cutaneous squamous cell carcinoma in situ, actinic cheilitis, hypertrophic scars, and keloids; it is useful for epidermal and dermal analgesia; drug delivery may be increased through the application of heat, pressure, or occlusion, or by using an aqueous drug solution; laser settings should be selected to ensure that channel diameter is greater than the delivered molecule; antibiotic prophylaxis is not recommended, except with impaired wound healing; antiviral prophylaxis is recommended when treating the face and genitalia; and antifungal prophylaxis is not recommended. The guideline's 15 recommendations address 5 areas of LADD use: (I) indications and contraindications; (II) parameters to report; (III) optimization of drug delivery; (IV) safety considerations; and (V) prophylaxis for bacterial, viral, and fungal infections. Conclusions and Relevance: This systematic review and Delphi consensus approach culminated in an evidence-based clinical practice guideline for safe and effective use of LADD in a variety of applications. Future research will further improve our understanding of this novel treatment technique.

Collagenase Clostridium Histolyticum-aaes for Treatment of Cellulite: A Pooled Analysis of Two Phase-3 Trials.

Background: Collagen-rich fibrous septae and subcutaneous adipose protrusions play a role in cellulite pathophysiology. Collagenase clostridium histolyticum-aaes (CCH-aaes) injection causes enzymatic release of septae to resolve cellulite depressions and create a skin smoothing effect. This analysis pooled data from two identically designed, phase-3, randomized, double-blind, placebo-controlled studies to examine the efficacy and safety of CCH-aaes. Methods: Adult women with moderate/severe cellulite (3-4 on Clinician Reported Photonumeric Cellulite Severity Scale and Patient Reported Photonumeric Cellulite Severity Scale) on the buttocks received up to three treatment sessions (Days 1, 22, and 43) of subcutaneous CCH-aaes 0.84 mg or placebo per treatment area. Composite and individual component response (≥2-level or ≥1-level improvement from baseline in Patient Reported Photonumeric Cellulite Severity Scale and/or Clinician Reported Photonumeric Cellulite Severity Scale) and additional patient-reported outcomes were determined at Day 71. Results: Analysis included 424 CCH-aaes-treated and 419 placebo-treated women. CCH-aaes-treated women were 5.9 times more likely than placebo-treated women to be ≥2-level composite responders at Day 71 (odds ratio [95% confidence interval], 5.9 [2.2-15.4]; P < 0.001). A significantly greater percentage of CCH-aaes-treated women versus placebo-treated women were ≥1-level composite responders at Day 71 (39.4% versus 14.6%; P < 0.001). Subgroup analyses indicated no apparent impact of Fitzpatrick skin type category and baseline cellulite severity (moderate/severe) on CCH-aaes efficacy. An inverse relationship between age and CCH-aaes response was observed in those with a body mass index less than 32 kg per m2. The most common adverse events with CCH-aaes were injection-site bruising and injection-site pain. Conclusion: CCH-aaes treatment significantly improved moderate-to-severe buttock cellulite appearance and was generally well tolerated.

Cutaneous Vascular Compromise and Resolution of Skin Barrier Breakdown After Dermal Filler Occlusion-Implementation of Evidence-Based Recommendations Into Real-World Clinical Practice.

BACKGROUND: Vascular occlusions that threaten skin integrity, although not an emergency like those that threaten a patient's vision, is an urgent situation. Accurately interpreting physical examination findings is paramount. The use of high-dose, pulsed hyaluronidase is the mainstay of therapy; however, adjunctive measures that may optimize clearance of an occlusion and/or skin barrier repair such as the use of image guidance and hyperbaric oxygen should be considered. OBJECTIVE: To provide a review of the literature on the treatment of vascular occlusions threatening skin barrier integrity and develop a step-wise treatment guide. MATERIALS AND METHODS: The authors searched PubMed for peer-reviewed studies, consensus statements, case series, and case reports using a variety of keywords. RESULTS: Twenty-six articles focusing on vascular occlusions threatening the skin barrier were reviewed. The authors collectively agreed on treatments to reverse vascular occlusions and restore the skin barrier. The importance of high-dose, pulsed hyaluronidase was clear. Therapies that lacked evidence such as sodium thiosulfate were also revealed. CONCLUSION: A vascular occlusion that threatens skin integrity is an urgent matter which requires accurate interpretation of physical examination findings that will help guide intervention. High-dose, pulsed hyaluronidase along with adjunctive measures performed in a step-wise manner is key to an optimal outcome.

Serious Adverse Events With Injectable Fillers: Retrospective Analysis of 7,659 Patient Outcomes.

BACKGROUND: In total, 2.7 million injectable filler treatments were performed in 2019 in the United States. Although generally considered to be a safe treatment modality, adverse events may occur in rare situations. OBJECTIVE: Analyze serious adverse events from injectable filler treatments, including infections, cutaneous necrosis, blindness, or delayed-onset nodule formation, spanning 11 years for 3 board-certified dermatologists and review their incidence, management, and outcomes. MATERIALS AND METHODS: A retrospective analysis was performed of injectable filler treatments spanning 11 years at a multipractitioner outpatient clinic. Serious adverse events were identified, and treatment measures were documented. A literature search was performed to determine recent trends and outcomes for comparison. RESULTS: Between January 2009 and August 2020, 18,013 mL of injectable filler was administered to 7,659 patients. Of the 18,013 mL administered, 74.1% comprised hyaluronic acid derivatives, 19.19% poly-l-lactic acid, and 6.71% calcium hydroxylapatite. Four serious adverse events were identified. Three events were delayed-onset skin nodule formation. One adverse event was related to vascular compromise and subsequent cutaneous necrosis. After appropriate treatment, all adverse events resolved without significant long-term sequelae. CONCLUSION: Serious adverse events associated with injectable fillers, when performed by board-certified dermatologists, are extremely rare and can be successfully managed with appropriate treatment.

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.

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.

Collagenase Clostridium Histolyticum-aaes for the Treatment of Cellulite in Women: Results From Two Phase 3 Randomized, Placebo-Controlled Trials.

BACKGROUND: Fibrous septae play a role in contour alterations associated with cellulite. OBJECTIVE: To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite. MATERIALS AND METHODS: Two identically designed phase 3, double-blind, randomized studies (RELEASE-1 and RELEASE-2) were conducted. Adult women with moderate/severe cellulite (rating 3-4 on the Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] and Clinician Reported PCSS [CR-PCSS]) on the buttocks received up to 3 treatment sessions of subcutaneous CCH 0.84 mg or placebo per treatment area. Composite response (≥2-level or ≥1-level improvement from baseline in both PR-PCSS and CR-PCSS) was determined at Day 71. RESULTS: Eight hundred forty-three women received ≥1 injection (CCH vs placebo: RELEASE-1, n = 210 vs n = 213; RELEASE-2, n = 214 vs n = 206). Greater percentages of CCH-treated women were ≥2-level composite responders versus placebo in RELEASE-1 (7.6% vs 1.9%; p = .006) and RELEASE-2 (5.6% vs 0.5%; p = .002) and ≥1-level composite responders in RELEASE-1 (37.1% vs 17.8%; p < .001) and RELEASE-2 (41.6% vs 11.2%; p < .001). Most adverse events (AEs) in the CCH group were injection site related; few CCH-treated women discontinued because of an AE (≤4.3%). CONCLUSION: Collagenase clostridium histolyticum-aaes significantly improved cellulite appearance and was generally well tolerated.

Nonsurgical Postpartum Abdominal Rejuvenation: A Review and Our Experience.

BACKGROUND: A significant population of aesthetic patients are postpartum women motivated to achieve a more youthful abdomen. Although traditionally, abdominoplasty was the treatment of choice, minimally invasive procedures have grown in popularity because of minimal downtime and the favorable side effect profile. so many women share concerns regarding their postpartum abdominal appearance, a limited number of studies focus specifically on postpartum abdominal rejuvenation. OBJECTIVE: To review pertinent aspects of abdominal anatomy, associated changes with pregnancy, available nonsurgical cosmetic procedures, and to provide our experience to help guide treatment combinations which comprehensively address the concerns of the postpartum patient. MATERIALS AND METHODS: A review of the literature surrounding nonsurgical treatment options for postpartum abdominal lipohypertrophy, muscle changes, tissue laxity, and striae gravidarum, along with the authors' experience in this area are provided. CONCLUSION: This review summarizes available nonsurgical modalities to address postpartum abdominal defects, including procedures that tone muscles, reduce fat, tighten skin, and improve the appearance of striae. Both the published literature and the authors' experience favor a combination of treatments to address the various lamellae affected by pregnancy. Further clinical trials focusing on the postpartum patient would further help create a standardized approach for postpartum abdominal rejuvenation.

Lower eyelid xanthelasma following hyaluronic acid filler injections to the tear troughs.

INTRODUCTION: Adverse effects from dermal fillers are uncommon. We report a case of filler-induced xanthelasma at the bilateral infraorbital region in a 43-year-old woman after multiple injections of hyaluronic acid to correct tear trough depression. MATERIAL AND METHODS: We report a case of a 43-year-old woman with a chief complaint of skin discoloration of the bilateral lower eyelids. Her history was significant for ten sessions of hyaluronic acid filler for tear trough deformity between December 2008 and May 2016. On clinical examination, she exhibited thin, soft, and yellow papules to her lower medial infraorbital hollows. A punch biopsy showed foamy histiocytes with a background of hypervascularization and focal extracellular lipid in the superficial dermis, consistent with xanthelasma. RESULTS: Xanthelasma was treated with multiple passes of Er:YAG laser (Sciton Contour TRL) with a 4 mm spot size, fluence 7.5 J/cm2, and ablate/coagulate 50/50 at 6 Hz until clearance occurred. The perilesional skin was treated with 1-2 passes, fluence 7.5 J/cm2, ablate/coagulate 50/0 to blend in the cosmetic unit. Six-month follow-up showed notable improvement of all lesions. DISCUSSION: There is a paucity of treatments described for filler-induced xanthelasma reaction. While broad conclusions cannot be drawn from one case, our experience indicates that complete resolution can be achieved with Er:YAG ablation. We hypothesize that this laser is an optimal treatment, as it can vaporize the lipid contents while minimizing adverse effects, such as scars and hyperpigmentation.

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.