Long-Term Efficacy and Tolerability of a Daily Serum for Rejuvenation and Prejuvenation of Facial Skin.

Onjectives: To evaluate the long-term efficacy and tolerance of an anti-aging daily serum (AADS) when used twice-daily over 12 weeks by women with moderate skin fatigue and overall photodamage. The treatment targeted rejuvenation and prejuvenation of the facial skin. Method: This was an institutional review board (IRB)-approved, randomized, single-center, double-blinded, vehicle-controlled (VC) study involving healthy subjects. Seventy female subjects were recruited aged 30 to 60 years old, Fitzpatrick skin types I to VI, with moderate overall photodamage, facial skin dullness, and skin firmness. Subjects underwent a 1-week washout period with a skincare regimen consisting of a cleanser, moisturizer, and sunscreen. Subjects were randomized to apply the AADS or VC to their face including upper eyelid, twice-daily for 12 weeks. Long-term efficacy and tolerance, self-assessment questionnaire, and VISIA® clinical photography were performed at baseline, weeks 4, 8, and 12.  Results: Statistically significant improvements in live, clinically graded efficacy parameters were demonstrated at post-baseline timepoints. Facial skin firmness, radiance, and roughness showed the most significant improvements at week 12. Analysis between treatments, in both live and photo-graded parameters, demonstrated merit of the AADS. VISIA® analysis further substantiated the efficacy of the AADS vs the VC. The AADS was well tolerated by clinical scoring and rating by subjects.  Conclusion: The AADS is effective in improving skin fatigue and overall photodamage after 12 weeks of twice-daily application compared with the VC. The AADS is a possible skincare solution for patients seeking a serum with skin rejuvenation and prejuvenation benefits. Citation: Reid L, Palm MD, Kononov T, et al. Long-term efficacy and tolerability of a daily serum for rejuvenation and prejuvenation of facial skin. J Drugs Dermatol. 2023;22(9):917-924. doi:10.36849/JDD.7393.

A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements.

BACKGROUND: Skin quality may be assessed by degrees of skin smoothness, fine lines, and hydration. VYC-12L is a recently developed hyaluronic acid filler to improve skin quality. OBJECTIVE: This was a randomized, evaluator-blind study assessing safety and effectiveness of intradermal VYC-12L treatment for improving cheek skin smoothness, fine lines, and hydration. METHODS: Participants (≥22 years) with moderate-to-severe investigator-assessed Allergan Cheek Smoothness Scale (ACSS) scores were randomized in 2:1 ratio to receive VYC-12L or control (no treatment with optional treatment). Effectiveness was assessed 1 month after last injection (initial or touch-up) by a responder rate (≥1-grade improvement from baseline on both cheeks) using investigator-rated ACSS and Allergan Fine Lines Scale (AFLS), and tissue dielectric constant probe-measured skin hydration. Safety was evaluated throughout. RESULTS: Participants (VYC-12L, n = 131; control, n = 71) were 86.1% female with a median age of 58.0 years. At month 1, ACSS and AFLS responder rates were statistically significantly higher in the VYC-12L group (57.9%, 58.3%, respectively) than in the untreated controls (4.5%, 5.4%, respectively; p < .001). VYC-12L ACSS and AFLS responder rates remained consistent throughout the 6-month follow-up. Six participants reported treatment-related adverse events; none led to study discontinuation. CONCLUSION: VYC-12L is an effective, well-tolerated treatment for lasting improvement of cheek skin smoothness, fine lines, and hydration.

Real-world effectiveness and safety of collagenase clostridium histolyticum-aaes injections for the treatment of thigh cellulite in women: An open-label study interim analysis.

BACKGROUND: Collagenase clostridium histolyticum-aaes (CCH-aaes) is approved in the United States for moderate-to-severe cellulite in the buttocks of adult women. AIM: Interim analysis to evaluate efficacy/safety of CCH-aaes in the treatment of thigh cellulite. METHODS: Data were analyzed from a phase 3, open-label study (REAL). Women with mild-to-moderate cellulite on both thighs (Clinician Reported Photonumeric Cellulite Severity Scale score, 2 or 3) received ≤0.84 mg (volume, 18 ml) of CCH-aaes subcutaneously, in up to 12 dimples per posterolateral thigh, in up to 3 treatment sessions (Days 1, 22, and 43). Follow-up was on Day 90 (interim cutoff). A subset of women participated in the concurrent study (PIXELS), which included high-definition photography and 3D-image scanning of treatment areas. RESULTS: Twenty-two women (44 thighs) were included in the interim analysis (mean age, 42.3 years; thighs with mild cellulite, 68.2%). Investigators reported high percentages of responders (score of "improved" or better on Investigator Global Aesthetic Improvement Scale) at Day 90 for either thigh (86.4%; primary endpoint) or both thighs (72.7%). Patient-reported bother due to cellulite was reduced at Day 90; mean change was 15.3 points (85.5% reduction) in BODY-Q Appraisal of Cellulite Scale total score (possible range, 11-44). In PIXELS analysis, Day 90 3D-image scans showed improvement from baseline in skin roughness in some of the treated thigh areas. The most commonly reported adverse events were injection-site bruising and pain (95.5% and 50.0% of patients, respectively). CONCLUSIONS: CCH-aaes treatment of mild-to-moderate thigh cellulite was effective and generally well tolerated, with markedly reduced cellulite-related bother.

Spot Reduction of Localized Fat Deposits on the Lateral Thighs by Simultaneous Emission of Synchronized Radiofrequency and High-Intensity Focused Electromagnetic Energy: Magnetic Resonance Multicenter Study.

BACKGROUND: Unwanted lateral fat most prominently affects the female population and may cause self-esteem issues. OBJECTIVE: To investigate the effectiveness and safety of synchronized high-intensity focused electromagnetic (HIFEM) + radiofrequency (RF) for the treatment of lateral thigh adipose tissue. MATERIALS AND METHODS: Ninety-three subjects (21-70 year old) received 4, 30-minute HIFEM + RF treatments of the lateral thighs. Magnetic resonance imaging (MRI) of the treated area was obtained at baseline, 1, 3, and 6 months post-treatment to document the changes in fat layer thickness. Furthermore, digital photographs, circumference measurements of the lateral thighs, subjects' satisfaction questionnaires, and therapy safety and comfort were documented. RESULTS: Magnetic resonance imaging revealed a significant reduction of fat tissue in the saddlebag region peaking at 3 months (-18 ± 5.5 mm; N = 51). The thigh circumference measured at 3 predefined levels decreased on average by 2.3 cm, with the greatest change at the level of 10 cm below the infragluteal fold (-3.5 cm, 3-month follow-up). Results were maintained at 6 months. No adverse events were recorded. The therapy was found comfortable with a high satisfaction rate. CONCLUSION: High-intensity focused electromagnetic + RF treatment to the lateral thigh area demonstrated effectiveness in long-term fat thickness reduction by MRI imaging. Secondary endpoint showed simultaneous effectiveness and safety.

Multicenter evaluation of a topical hyaluronic acid serum.

BACKGROUND: A new hyaluronic acid (HA) formulation was developed based on high molecular weight (MW) compounds used on the surface of the skin while using peptides to stimulate the high MW HA production by fibroblasts and keratinocytes from within the skin layers. Detailed science has been submitted to this journal in a previous publication. This multicenter study aims to validate the science by demonstrating the safety and efficacy of the product in the clinical realm. OBJECTIVES: This study evaluated the efficacy and safety of a topical HA serum in facial skin. METHODS: An open-label clinical study was undertaken over 4 months from November 2021 to March 2022. Participants applied the topical serum twice daily and were provided a gentle cleanser and an SPF 30+ to use in the morning. Follow-up visits were conducted at weeks 2, 4, and 8. At every visit, participants were measured for hydration post 15 minutes of cleansing the skin and post 15 minutes of product application for cumulative skin hydration sensor measurements. Additional procedures included participant assessments and satisfaction, investigator assessments, biopsies, and photography. RESULTS: At each follow-up visit, there was an increase in hydration measurements compared to baseline, in both immediate scores and cumulative long-term scores. At weeks 4 and 8, there was a statistically significant increase in hydration compared to baseline and the prior visit. Participants' assessments progressively increased over 2-, 4-, and 8-week intervals with significantly favorable ratings in all measured parameters. Similarly, investigator assessment grades were statistically significant (p < 0.0001) for decreased fine lines/wrinkling, crepiness, texture, erythema, and dryness, and increased (p < 0.0001) for moisture/hydration. Histology revealed increased CD44 staining in 6 of the 7 participants biopsied, denoting increased HA stimulation. In all of the participant biopsies, H&E staining demonstrated improvement in solar elastosis. Photography revealed remarkable improvement in erythema, tone, and texture. CONCLUSIONS: The study results demonstrated that the formulation produced significant improvements in immediate and long-term hydration effects on the skin as measured by the skin hydration sensor, 'wearifi' technology, comparison of before and after biopsies, and participant and investigator assessments. This high MW HA formulation produced excellent clinical improvement in skin health and hydration.

Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines.

BACKGROUND: OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for approximately 3 to 4 months. Small studies have suggested that >20-U doses may increase the efficacy and duration of response for GLs. OBJECTIVES: The aim of this study was to evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. METHODS: This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale. The following parameters were evaluated: the percentage of subjects with investigator-assessed ≥1-grade Facial Wrinkle Scale improvement from baseline at maximum frown (responders) at Week 24; the estimated median duration of response; the proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire follow-up Items 1 to 5; and treatment-emergent adverse events. RESULTS: The modified intent-to-treat population (N = 226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P < 0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; P < 0.05 vs 20 U at Week 24). Facial Line Satisfaction Questionnaire results indicated high subject satisfaction. The incidence and severity of treatment-emergent adverse events did not exhibit a dose-response effect. CONCLUSIONS: GL treatment with onabotulinumtoxinA doses >20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20-U dose with no apparent impact on safety variables.

Designing topical hyaluronic acid technology-Size does matter .

INTRODUCTION: Hyaluronic acid (HA) plays an important role in cellular and extracellular matrix (ECM) homeostasis. Recent studies demonstrate that low molecular weight (MW) HA has pro-inflammatory characteristics while high MW HA is considered anti-inflammatory and regenerative. In formulating a topical HA product, the possibility of creating a focused high MW HA technology was posed, combining external surface high MW HA constituents with active agents promoting fibroblast production of high MW in the depths of the dermis. METHODS: Human dermal fibroblasts and keratinocytes were treated with various agents, and RNA sequencing (RNA-seq) was conducted to identify genes involved in HA synthesis. HA production by fibroblasts was assessed by collecting the culture supernatant, concentrating the protein, and conducting polyacrylamide gel electrophoresis (PAGE). The gel was stained with Stains-All to identify bands relative to known HA products of different MWs. Subsequently, the supernatants were treated with hyaluronidase to confirm the bands corresponded to HA. RESULTS: The RNA-seq results revealed a variety of agents upregulated HA-related genes. However, a potent upregulation of HA synthesis gene was observed by hexapeptide-11 in the keratinocytes and a newly identified proprietary octapeptide in the fibroblasts. PAGE demonstrated not only robust production of HA by octapeptide, but significantly, the HA produced was ~2 Mega Daltons in size. Octapeptide was the most potent stimulator among the tested agents. CONCLUSION: Comprehensive in vitro testing identified a group of active agents that stimulated high MW HA production. This novel approach to HA topical application with exclusively high MW HA production should maximize hydration capacity while encouraging regenerative activity within the ECM. Multi-center trials are underway.

Developing a Topical Adjunct to Injectable Procedures.

Injectable procedures have come to play an enormous part in everyday aesthetic medical practice. Whether its use is directed at volumizing with fillers, decreasing volume using enzymes, skin-tightening using multi-needle approaches, or neuromuscular blockade, the injectable route is the means of delivery in all these cases, making injectable procedures the most common aesthetic procedure performed. As with all procedures, expected and unexpected consequences may follow including bruising, swelling, discomfort, and the possibility of infection. This paper outlines the scientific process and validation of a product designed as an adjunct to injection therapy and the scientific deep dive needed to encompass both symptomatic and adjunctive purposes. On the symptomatic side, bruising, swelling, and pain were considered, while volumetric enhancement, regeneration, and anti-microbial/biofilm effects were desired outcomes from the adjunctive perspective. Utilizing peptides and active agents aimed at reducing excess residual iron and stimulating macrophage absorption of red blood cells, we were able to achieve efficient resolution of bruising. In addition, peptides were included to stimulate collagen, elastin, and hyaluronic acid in synergy with the injectable. Anti-inflammatory, antimicrobial, and antibiofilm agents were added to aid in the safety profile of the injectable. In vivo testing of bruising resolution demonstrated that at day 2/3, participants using the study product (INhance Post-Injection Serum with TriHex Technology®, Alastin Skincare, Inc. Carlsbad, CA) had 73% less bruise color intensity and statistically significant improvement over the bland moisturizer. Overall, 81% of subjects applying the study topical product had less bruising at day 2/3 compared to the bland moisturizer. J Drugs Dermatol. 2020;19(4):398-404. doi:10.36849/JDD.2020.5016.

Efficacy, Patient-Reported Outcomes, and Safety for Millennial Subjects Treated With OnabotulinumtoxinA for Moderate to Severe Horizontal Forehead Lines.

BACKGROUND: Millennials (aged 18-34 years) represent a growing segment of the facial aesthetic market. OBJECTIVE: To evaluate investigator-assessed efficacy, patient-reported outcomes (PROs), and safety for millennials versus subjects aged at least 35 years after onabotulinumtoxinA treatment of forehead lines (FHL) across 2 phase 3 studies. METHODS: Eligible subjects with moderate to severe FHL received onabotulinumtoxinA (FHL: 20 U; glabellar lines: 20 U, with/without 24 U in crow's feet line regions) or placebo. All findings were pooled by the age group. RESULTS: Millennials composed 15% of subjects (176/1,178). Day 30 responder rates of at least 1-grade Facial Wrinkle Scale improvement in FHL severity for millennials versus subjects aged 35 years and older were 100% versus 97.8% at maximum eyebrow elevation and 78.4% versus 83.5% at rest, respectively. Responder rates were significantly greater with onabotulinumtoxinA than placebo (p ≤ .015) for both groups through Day 180. Similar trends were observed for achieving none/mild severity. Both age groups reported high satisfaction rates and improved psychological impacts with onabotulinumtoxinA treatment. No new safety signals were detected. CONCLUSION: OnabotulinumtoxinA treatment was well tolerated, and both age groups experienced significant improvements in FHL severity, high satisfaction, and improved psychological impacts after treatment. Millennials reported numerically greater improvements.

Final Data from the Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR)

Perceptions of attractiveness can be negatively affected by submental fullness. Patients seeking to improve their submental contour have a variety of treatment options including surgical procedures, energy-based devices, and injectable treatment. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to provide insights into the treatment of submental fat (SMF) in clinical practice. CONTOUR was a prospective observational study that enrolled 1029 adults at 91 sites in the United States and Canada. Patients were followed until treatment completion, discontinuation, or 1 year elapsed from enrollment without treatment. Final data from CONTOUR are reported here. Of the 676 patients who underwent treatment, 570 were treated with ATX-101 (deoxycholic acid injection), 77 with energy-based devices, 23 with surgical liposuction, 5 with laser liposuction, and 9 with other treatments. The majority of treated patients were facial aesthetic treatment naive. A markedly greater percentage of patients with mild or moderate SMF at baseline received treatment with ATX-101 or energy-based devices, whereas the majority of patients undergoing liposuction had severe or extreme SMF. Physicians most frequently cited a preference for a noninvasive/minimally invasive procedure as the reason for choosing either ATX-101 or energy-based devices. The majority of patients were at least partially satisfied with results, regardless of the chosen treatment. Data from CONTOUR indicate that cost is the most important factor in a patient's decision to undergo treatment, that choice of treatment method is most influenced by SMF severity and preference for nonsurgical versus surgical intervention, and that the availability of noninvasive/minimally invasive options has made SMF treatment an attractive first procedure for patients who have not undergone previous facial aesthetic treatments. ClinicalTrials.gov identifier: NCT02438813. J Drugs Dermatol. 2019;18(1):40-48.

Topical Transdermally Delivered Lidocaine and Benzocaine Compared to Compounded Lidocaine/Tetracaine During Microfocused Ultrasound With Visualization Treatment.

OBJECTIVE: The efficacy of various pre-medication strategies for comfort management during microfocused ultrasound with visualization (MFU-V) treatment has not been studied. The present objective was to compare 2 topical analgesics (lidocaine 4% and benzocaine 20%) formulated with a novel transdermal delivery system with compounded lidocaine 23%/tetracaine 7% (23/7) to mitigate discomfort during MFU-V treatment. METHODS: This was a randomized, double-blinded, split-face study. One hour before MFU-V, subjects (N=14 females) received 50 mg IM meperidine/25 mg IM promethazine/5 mg oral diazepam. Fifteen minutes before treatment, 1 side of the face was treated with 1 application of 4% lidocaine, followed by 1 application of 20% benzocaine; the contralateral side was treated with 2 applications of 23/7 (to maintain blinding). Numbness was assessed by blinded evaluator (scale: 1=completely numb to 4=not numb) pre-treatment. Subject pain scores (scale: 0=no pain to 10=worst pain) were collected post-treatment. Adverse events and subjective clinician measures were also assessed. RESULTS: Mean subject pain scores for 23/7 and lidocaine 4%/benzocaine 20% were 5.6 and 5.7, respectively. Mean numbness scores were similar for 23/7 (2.5) and lidocaine 4%/benzocaine 20% (3.0). Clinicians rated both products as "very easy" to apply. For lidocaine 4%/benzocaine 20%, 7.1% of subjects required no pauses during treatment, vs 14.3% for 23/7. However, more subjects required 4+ pauses with 23/7 (21.4% vs 7.1%). Lidocaine 4%/benzocaine 20% was preferred by 78.5% of subjects; 35.7% rated lidocaine/benzocaine 20% 4% as "Very Effective" vs 7.1% for 23/7. No adverse events were reported. CONCLUSIONS: Lidocaine 4% and benzocaine 20% formulations utilizing a novel transdermal delivery system perform similarly to compounded lidocaine 23%/tetracaine 7% for discomfort mitigation during MFU-V treatment. More subjects preferred lidocaine 4%/ benzocaine 20% and rated it as "very effective" vs the compounded product. Fewer treatment pauses due to patient discomfort when using the lidocaine 4%/benzocaine 20% may translate to time efficiency. J Drugs Dermatol. 2018;17(7):729-734.

Consensus recommendations on the use of injectable poly-L-lactic acid for facial and nonfacial volumization.

Poly-L-lactic acid (PLLA) was approved for use in Europe in 1999. In the United States, it was approved by the Food and Drug Administration in 2004 for the treatment of facial lipoatrophy associated with human immunodeficiency virus, and in 2009 for cosmetic indications in immune-competent patients. The need for consistent, effective PLLA usage recommendations is heightened by an increased consumer demand for soft tissue augmentation and a shift toward a younger demographic. Over the past 14 years, considerable experience has been gained with this agent, and we have come to better understand the clinical, technical, and mechanistic aspects of PLLA use that need to be considered to optimize patient outcomes. These consensus recommendations regarding patient selection, proper preparation and storage, optimal injection techniques, and other practical considerations reflect the body of evidence in the medical literature, as well as the collective experience of this author group.

Filler frontier: what's new and heading West to the US market.

The amount of fillers approved by the United States Food and Drug Administration (FDA) for use in facial volume augmentation is diminutive in comparison to filler products employed worldwide. In the near future, several new hyaluronic acid filler products will be available to the United States market. Already approved fillers include Belotero Balance for fine lines, Juvéderm Voluma XC for midfacial volume loss replacement, and Restylane Silk for perioral lines and lip augmentation. Volbella, currently under FDA evaluation, will be used for fine-line correction and lip augmentation. The physiochemical properties, best practices, clinical uses, and side effects of these fillers are discussed. Additionally, evolving techniques such as the use of blunt-tipped microcannulas are explained.

Evaluation of the effect of fractional laser with radiofrequency and fractionated radiofrequency on the improvement of acne scars.

BACKGROUND: Options for acne scar reduction include peels, subcision, fillers, lasers, dermabrasion, and surgical excision, although not all are applicable in darker skin types. A novel device with a handpiece combining optical and radiofrequency (RF) energies along with a fractionated RF handpiece is available for nonablative resurfacing. OBJECTIVES: Our primary objective was to evaluate the improvement in acne scars and skin texture. Secondary objectives were determination of patient satisfaction and comfort and evaluation of scar pigmentation improvement. Patients received five treatments at 30-day intervals. Post-treatment follow-up visits were performed 30 and 90 days after the last treatment. RESULTS: A 72.3% decrease (p<.001) was observed on the acne scar scale from day 1 to 210. From day 30 to 210, investigator-rated changes in scarring, texture, and pigmentation improved 68.2% (p<.001), 66.7% (p<.001), and 13.3% (p=.05), respectively. Patient satisfaction scores showed no significant change over time, although patient-evaluated overall improved scores increased 60% over baseline (p=.02). CONCLUSION: This technology may be a useful, nonablative resurfacing treatment for acne scarring. Scarring, texture, and pigmentation improved significantly according to investigator-rated assessment parameters. Although patient satisfaction scores did not improve, overall improvement scores did.

Sequential treatment with triple combination cream and intense pulsed light is more efficacious than sequential treatment with an inactive (control) cream and intense pulsed light in patients with moderate to severe melasma.

BACKGROUND: Triple combination (TC) cream is a stable combination of fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% and is currently the only hydroquinone-containing drug approved by the Food and Drug Administration for the treatment of melasma. OBJECTIVE: To evaluate the safety and efficacy of TC cream when used sequentially with intense pulsed light (IPL) treatments in patients with moderate to severe melasma. MATERIALS & METHODS: This was a 10-week, split-face study in which 56 patients with symmetrical melasma lesions were treated with TC cream on one side of the face and an inactive control cream on the other side of the face. Patients also had two IPL treatments at weeks 2 and 6. (Topical treatment was suspended during IPL treatments ± 1 day.) RESULTS: Melasma severity was significantly less with TC cream and IPL than with inactive cream and IPL at weeks 6 (p=.007) and 10 (p=.002). Improvement in melasma was greater with TC cream and IPL than with inactive cream and IPL according to investigator and patient evaluations at weeks 6 and 10 (p<.001 for both time points). Treatment with TC cream and IPL was well tolerated. CONCLUSION: The results of this study suggest that TC cream and IPL treatment is an effective and safe treatment option for patients with melasma.

Safety and efficacy comparison of blue versus red light sources for photodynamic therapy using methyl aminolevulinate in photodamaged skin.

BACKGROUND AND OBJECTIVE: methyl aminolevulinate (MAL) is a recently FDA-approved molecule for photodynamic therapy (PDT) in the treatment of nonhyperkeratotic actinic keratoses (AK). In the U.S., aminolevulinic acid (ALA) has been used in an off-label manner with photodynamic therapy for the treatment of chronic photodamage. The published use of MAL-PDT for photorejuvenation is more limited. MAL-PDT is usually conducted with a red light source, ALA-PDT with a blue light source. The purpose of this study is to compare the use of red versus blue light sources in the treatment of photodamage using MAL-PDT, measuring safety and efficacy outcomes following treatment. STUDY DESIGN/MATERIAL AND METHODS: eighteen adult patients with moderate-to-severe photodamage of the head or upper trunk were enrolled in a prospective, single center trial of MAL-PDT for photorejuvenation. Intrapatient randomization determined split-area treatment with a blue or red light source. The majority of patients were also treated with pulsed dye laser (PDL) and/or intense pulsed light (IPL) for photoactivation. Digitial photography documented the treatment area at each visit (days 0, 2, 7 and 30). Patient and physician scoring of photodamage occurred at baseline and final visits. Side effects following MAL-PDT were evaluated. RESULTS: no statistically significant differences in signs of photodamage following MAL-PDT were observed between blue versus red light treated sides. The greatest improvement in photodamage measures following 1 MAL-PDT were pigmentation, AK and erythema. Side effects were mild in nature and did not differ between treatment sides, and all but mild erythema resolved by day 7. CONCLUSION: blue and red light have similar efficacy as the light source for MAL-PDT when combined with other light sources. Side effects following MAL-PDT with red versus blue light were similar and mild in severity. MAL-PDT is an effective treatment modality for chronic photodamage, in particular AK and pigmentation.

Foam sclerotherapy for reticular veins and nontruncal varicose veins of the legs: a retrospective review of outcomes and adverse effects.

BACKGROUND: Sclerotherapy is the criterion standard of treatment for reticular veins. Foam sclerotherapy is safe and effective, although current guidelines limit the volume of foam used per session. OBJECTIVE: To demonstrate the safety and efficacy of large-volume foam sclerotherapy for the treatment of reticular and nontruncal leg veins. METHODS & MATERIALS: A retrospective review was conducted on all patients undergoing sclerotherapy from 2003 to 2009. Contacted patients graded side effect severity and the degree of vein resolution on a 4-point scale (0-3). The occurrence of cardiovascular or pulmonary events was also recorded. Sclerosant volumes were retrieved from patient records. RESULTS: One thousand one hundred eighty-seven patients underwent sclerotherapy; 419 were successfully contacted of whom 325 had received foam sclerotherapy. The average volume of foam used per session was 16.9 mL. The average rating of adverse events was minimal to mild for all categories including hyperpigmentation (0.35), ulceration (0.06), pain (0.22), and matting or new vessel formation (0.70). The average improvement score was 1.94 (moderate improvement). No serious adverse events occurred. CONCLUSION: Large-volume foam sclerotherapy appears to be safe and effective in the treatment of intracutaneous leg varicosities. Serious adverse events are a rare occurrence, even with sclerosant treatment volumes exceeding current guidelines.