Advancing precision acne therapy using a novel photopneumatic device.

Photopneumatic therapy (PPT) combines vacuum and pulsed, broadband light to extract debris and bacteria from the pilosebaceous units; monotherapy is unexplored. Facial acne lesions and skin texture were evaluated after up to six PPT treatments, 1-2 weeks apart for 15-20 minutes per treatment using customized energy settings, in seven female patients with inflammatory, comedonal and pustular lesions. Lesion and redness reduction with improvement in skin texture and pore size were observed after 1-3 treatments; adverse effects were infrequent. PPT may optimize lesion clearance as monotherapy and/or as an adjuvant. The ability to change pulse structure, pulse duration, vacuum pressure and fluence allow for treatment that best matches skin type and acne severity.

Photopneumatic Technology for the Treatment of Mild-to-moderate Acne Vulgaris-A Review.

Acne vulgaris, despite being one of the most common dermatological diseases, remains challenging to treat. Acne lesion location and type, skin tone, genetics, and environmental factors influence mono- or multimodal therapeutic decisions. Combination topical and oral treatments may successfully reduce lesion count; however, these agents take time to work, and side effects are not uncommon. The long-term therapeutic engagement required to treat acne may be too costly or burdensome for many patients, which may impact treatment adherence, which can negatively impact patient outcomes. There is increased interest in noninvasive acne treatments to reduce side effects, provide rapid results, and foster treatment adherence. TheraClearX® X Acne System combines broadband pulsed light and vacuum suction technology. The combination of these two treatment modalities mechanically clears congested follicles and targets endogenous porphyrins produced by Cutibacterium acnes and other acnegenic bacteria. This article describes the proposed mechanism of action, treatment advantages, examples of treatment protocols, and anecdotal results using this combination device in the treatment of acne.

Perioral volumization using a temperature controlled fractionated radiofrequency device.

BACKGROUND AND AIMS: Cosmetic rejuvenation of the perioral area can be challenging due to a mix of skin laxity and volumetric loss. Current techniques including fillers, neurotoxins, and non-ablative and ablative resurfacing have several drawbacks and can create a stiff, box-shaped, unnatural appearance. Aside from filler, these techniques do not address deeper volume deficiency. Temperature controlled fractionated radiofrequency (FRF) provides consistent formation of new collagen, elastin, and hyaluronic acid. This has been reported to provide long-lasting results for the treatment of skin laxity and volume loss of the face and neck with a single treatment, but it has not been previously reported for perioral rejuvenation. PATIENTS/METHODS: We present a series of seven patients who were treated with perioral FRF, and we assessed their results objectively using a published, validated scale for lower face laxity. RESULTS: All of the patients in this case series showed improvement on the Facial Laxity Rating (FLR) scale after FRF treatment. CONCLUSIONS: This case series represents the first reported use of temperature controlled FRF for perioral rejuvenation. FRF is a promising option for low-risk, natural perioral rejuvenation with long-lasting results and few risks.

Bipolar fractionated radiofrequency midface lift: A retrospective review.

INTRODUCTION: Midface rejuvenation is an important component of overall facial rejuvenation. Traditionally, midfacial skin laxity and volume loss have been addressed with surgical midfacial lifting and soft tissue augmentation with dermal fillers. We present a novel noninvasive approach to midface rejuvenation with a bipolar fractionated radiofrequency (FRF) device that addresses both volume loss and improves skin laxity. METHODS: An institutional review board-approved retrospective review was performed and included subjects who received midfacial treatment with a bipolar FRF device. Follow-up photographs were objectively assessed by a blinded evaluator using a validated scale, the Facial Laxity Rating Scale. Paired t tests were used to evaluate the results for statistical significance. RESULTS: A total of 15 subjects were included in the study. The average age was 64 and ranged from 48 to 73. The average midface laxity score prior to treatment was 5.6 and post-treatment was 6.3 (p < 0.01). CONCLUSION: Bipolar FRF is a promising noninvasive intervention for midface rejuvenation.

Single Treatment Protocol With Microneedle Fractional Radiofrequency for Treatment of Body Skin Laxity and Fat Deposits.

BACKGROUND AND OBJECTIVES: Treatment modalities have been developed to address patient concerns with skin laxity and focal adipose excess. A previously published multicenter clinical trial reported improvement in cellulite severity after a single dermal and subcutaneous treatment on the upper thigh with a microneedle radiofrequency device. In the current study, this device was used to improve the esthetic appearance of body skin laxity and localized fat deposits above the knee, upper arms, and upper-mid back/axillary region ("bra-line"). STUDY DESIGN/MATERIALS AND METHODS: Subjects with cellulite, skin laxity, and/or subcutaneous adipose excess in the suprapatellar region of the anterior thigh, upper arms, and bra-line underwent a single dermal and/or subcutaneous treatment. Investigators and subjects assessed outcome at 1-, 3-, and 6-month follow-up, using 5-point Likert scales for global esthetic improvement, skin laxity improvement, and satisfaction. RESULTS: In total, 31 females (mean age 51 ± 9 years) with Fitzpatrick skin types I-IV received a single treatment on 62 treatment areas: 22 upper arms, 34 suprapatellar, and 6 bra-lines. Investigator assessments at 1, 3, and 6 months for global esthetic improvement and skin laxity for the upper arms and bra-line demonstrated improvements in 100% of subjects at all timepoints; for the suprapatellar region, these values were 69%, 92%, 65%, and 85%, 92%, 65%, respectively. Investigator satisfaction at each timepoint was satisfied or very satisfied in 80%, 100%, 90% for upper arms; 80%, 80%, 80% for bra-line; and 50%, 81%, 65% for suprapatellar region. Subject self-assessments at 1, 3, and 6 months for global esthetic improvement and skin laxity for the upper arms demonstrated improvements in 100% of subjects at all timepoints; for the bra-line, these values were 40%, 60%, 80%, and 60%, 60%, 80%, respectively; for the suprapatellar region, these values were 81%, 92%, 88%, and 69%, 85%, 88%, respectively. Subject satisfaction at each timepoint was satisfied or very satisfied in 80%, 100%, 100% for upper arms; 40%, 40%, 80% for bra-line; and 50%, 77%, 65% for suprapatellar. Treatments were well tolerated with subjects reporting transient erythema and edema associated with 69% and 46% of treatments, respectively. Mild bruising, resolving within 5 days, was reported after 32% of the treatments. CONCLUSION: Microneedle fractional radiofrequency provides a single treatment protocol to improve the esthetic appearance of body skin laxity and localized adipose excess to the upper arms, bra-line, and suprapatellar regions. Further study is warranted to evaluate the degree of improvement and long-term effect beyond 6 months post-treatment. Lasers Surg. Med. © 2021 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

Photodynamic Therapy with 5-aminolevulinic Acid 10% Gel and Red Light for the Treatment of Actinic Keratosis, Nonmelanoma Skin Cancers, and Acne: Current Evidence and Best Practices.

Photodynamic therapy (PDT) can be an effective treatment for actinic keratosis (AK) as well as selected non-melanoma skin cancers (NMSCs), such as Bowen's disease and superficial basal cell carcinoma. PDT has also demonstrated effectiveness in the management of acne vulgaris. Results from controlled clinical trials have shown the safety and efficacy of PDT for these conditions with the use of different photosensitizers and a wide range of light sources. PDT has been employed effectively as monotherapy and in combination with other topicals and alternate light or laser energy therapies. This article provides expert practical guidance for the use of the newest 5-aminolevulinic acid (ALA) product (ALA 10% gel) plus red light as monotherapy for AKs, NMSC, and acne. Here, information from clinical guidelines and a summary of supporting evidence is provided for each cutaneous condition. The authors also provide detailed guidance for employing ALA 10% gel, a photosensitizer precursor, for each of these applications.

Treatment of Erythematotelangiectatic Rosacea With Pulsed-Dye Laser and Oxymetazoline 1.0% Cream: A Retrospective Study.

BACKGROUND AND OBJECTIVES: Pulsed-dye laser (PDL) and oxymetazoline 1.0% cream are each used for the treatment of erythematotelangiectatic (ET) rosacea. PDL targets oxyhemoglobin and can reduce facial erythema and telangiectasias. Oxymetazoline 1.0% cream is an α adrenergic agonist, which has shown to reduce facial erythema. The aim of this study was to determine the degree of erythema improvement and telangiectasia clearance after combination treatment with PDL plus oxymetazoline 1.0% cream. STUDY DESIGN/MATERIALS AND METHODS: This retrospective study was conducted at two sites. Pre- and post-treatment cross-polarized images from subjects on combination treatment with PDL and oxymetazoline 1.0% cream were graded by a board-certified dermatologist at each practice. Blinded images were analyzed using the Clinical Erythema Assessment (CEA) Scale (0 = clear and 4 = severe). Unblinded images were analyzed using the five-point Telangiectasia Scale to determine the degree of improvement post-treatment compared with baseline (1 = <5% clearance and 5 = 75-100% clearance). RESULTS: Thirty-one subjects (20 females, 11 males) of age 51 ± 13 years (mean ± standard deviation) were included in the study after an average of 4 months (range: 1-13) of daily oxymetazoline 1.0% cream and two (range: 1-4) PDL treatments. At baseline, 87% of subjects had CEA Grade 2 (mild erythema) or higher. For erythema, 55% of subjects improved by at least one CEA grade and 13% achieved two grades of improvement post-treatment. For telangiectasias, 90% of subjects achieved at least a two-point clearance (5-25%), 62% at least a three-point clearance (25-50%), and 41% at least a four-point clearance (50-75%) post-treatment. Compared with subjects with baseline CEA Grade 1-2 (almost clear to mild erythema), significantly more subjects with baseline CEA Grade 3-4 (moderate to severe erythema) achieved at least one CEA grade of improvement (P = 0.021) and two grades of CEA improvement (P = 0.041). A higher percentage of baseline CEA Grade 3-4 subjects achieved at least a two-point clearance in telangiectasias (P = 0.055). CONCLUSIONS: Combination treatment with PDL and daily oxymetazoline 1.0% cream can safely and effectively reduce erythema and telangiectasias. Limitations include the retrospective design of the study, small sample size, and lack of a control group. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

Improper Potency and Impurities in Compounded Polidocanol

Polidocanol is an FDA-approved sclerosant indicated for treating uncomplicated spider veins and reticular veins in the lower extremities. Despite restrictions against compounding drugs that are essentially copies of FDA-approved or commercially available products, polidocanol is also available from compounding pharmacies and outsourcing facilites. Compounded drug products are not FDA-approved and have not undergone premarket FDA review for safety, effectiveness, and quality. Seven samples of polidocanol were obtained from three compounding pharmacies and analyzed using high pressure liquid chromatography. None of the samples contained the labeled concentration of polidocanol and five contained excessive levels of impurities. Since the potency and purity of compounded polidocanol injection cannot be assured, physicians who use these products should consider FDA-approved products to ensure optimal safety and efficacy. J Drugs Dermatol. 2019;18(11):1124-1127.

Prospective Multicenter Clinical Trial of a Temperature-Controlled Subcutaneous Microneedle Fractional Bipolar Radiofrequency System for the Treatment of Cellulite.

BACKGROUND: A bipolar fractional radiofrequency (RF) device was developed to generate cutaneous thermal injuries using a temperature-controlled microneedle electrode array. OBJECTIVE: Evaluate safety and efficacy of a novel subcutaneous microneedle RF for treatment of posterolateral thigh cellulite. METHODS: The study design was an institutional review board-approved multicenter clinical trial after a per-protocol analysis. Fifty subjects with Nurnberger-Muller Grade II or III cellulite were enrolled at 4 treatment centers and received 1 subcutaneous microneedle RF treatment (67°C/4-second duration). Efficacy was evaluated by blinded grading by 3 dermatologists using randomized, standardized photographs and investigator grading at baseline, 1-, 3-, and 6-month follow-up. As per the Food and Drug Administration, treatment success was defined by ≥1-point improvement on dimple number or severity of undulation irregularities scales by at least 2 of 3 blinded physicians. Study subjects' self-assessments and satisfaction questionnaires and procedural pain levels and adverse events were monitored. RESULTS: Blinded physician evaluations revealed a procedural success rate of 93% at 6-month follow-up. Procedural pain level was 3.74 ± 1.96 on a 10-point scale. There were no adverse events. Seventy-five percent of subjects were satisfied with the results at 6-month follow-up. CONCLUSION: The results indicate that subcutaneous microneedle RF treatment is safe and effective for long-term treatment of Type II and III cellulite in a single session.