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Eyebrow Lifting From High-Intensity, High-Frequency, Parallel Ultrasound Beams

Wang, Jordan V; Bajaj, Shirin; Kauvar, Arielle; Geronemus, Roy G
PMID: 37093677
ISSN: 1524-4725
CID: 5465022

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

Labadie, Jessica G; Ibrahim, Sarah A; Worley, Brandon; Kang, Bianca Y; Rakita, Uros; Rigali, Sarah; Arndt, Kenneth A; Bernstein, Eric; Brauer, Jeremy A; Chandra, Sunandana; Didwania, Aashish; DiGiorgio, Catherine; Donelan, Mattias; Dover, Jeffrey S; Galadari, Hassan; Geronemus, Roy G; Goldman, Mitchel P; Haedersdal, Merete; Hruza, George; Ibrahimi, Omar A; Kauvar, Arielle; Kelly, Kristen M; Krakowski, Andrew C; Miest, Rachel; Orringer, Jeffrey S; Ozog, David M; Ross, E Victor; Shumaker, Peter R; Sobanko, Joseph F; Suozzi, Kathleen; Taylor, Mark B; Teng, Joyce M C; Uebelhoer, Nathan S; Waibel, Jill; Wanner, Molly; Ratchev, Ina; Christensen, Rachel E; Poon, Emily; Miller, Corinne H; Alam, Murad
Importance/UNASSIGNED: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/UNASSIGNED:To develop recommendations for the safe and effective use of LADD. Evidence Review/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED: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.
PMID: 35976634
ISSN: 2168-6084
CID: 5299952

Treatment of facial and non-facial lentigines with a 730 nm picosecond titanium: Sapphire laser is safe and effective [Case Report]

Kauvar, Arielle N B; Sun, Rongrong; Bhawan, Jag; Singh, Gaurav; Ugonabo, Nkem; Feng, Hao; Schomacker, Kevin
OBJECTIVE:A 730 nm picosecond-domain laser was developed to improve the clearance of pigmented lesion and reduce adverse events. This study assessed the safety and efficacy of this system for the clearance of lentigines and explores how the short picosecond pulses interact with tissue via histology. STUDY DESIGN AND METHODS/METHODS:Twenty subjects with Fitzpatrick skin types II-IV were enrolled in this prospective, IRB-approved study. Four treatments were administered using a 730 nm picosecond-domain laser. Pre- and posttreatment photos were assessed by blinded reviewers at 4- and 12-week follow-up visits, using a 5-point clearance scale. Subject satisfaction was measured using a 5-point scale. Investigator Global Improvement Score (IGIS) was performed at the 4- and 12-week follow-up visits, using an 11-point clearance scale. Subject pain level was measured using an 11-point scale (no pain [0], extreme pain [10]). Histology of 730 and 532 nm picosecond pulses was compared with 755 and 532 nm nanosecond pulses. RESULTS:. Mean pain score was 3.6 of 10 for all four treatments. Ninety-nine percent of randomly paired 4-week posttreatment images and 100% of 12-week posttreatment images were correctly identified from their respective baseline images by three blinded reviewers. Mean IGIS demonstrated scores of 6.7 and 7.0 at 4- and 12-week follow-up visits, respectively. At the 4- and 12-week follow-up visits, 76% and 73% of subjects, respectively, were satisfied to highly satisfied. The mean clearance score for all 118 treatment areas was 3 of 4 in follow-up visits. At 12-week follow-up, 36% of 118 treatment areas had a clearance score of 4, and 38% had a clearance score of 3. Post treatment, there was typical erythema, edema, dryness, crusting, and itching but negligible purpura, no pinpoint bleeding, blistering or scarring, and no significant hyperpigmentation or hypopigmentation. Histology showed diffuse, focal epidermal vacuolization ~5-10 µm in diameter and mild extravasation of erythrocytes with 730 nm picosecond pulses, while diffuse epidermal vacuolization was observed with coalescence of vacuoles (~20-100 µm), junctional clefting and mild extravasation of erythrocytes with 755 nm nanosecond pulses. Picosecond pulses of the wavelength of 532 nm produced diffuse, focal epidermal vacuolization and larger dermal vacuoles to depths of 500 µm, while 532 nm nanosecond pulses produced diffuse epidermal vacuolization with coalescence of vacuoles and marked dermal hemorrhage. CONCLUSION/CONCLUSIONS:This study demonstrated the potential of a new 730 nm picosecond-domain laser for the clearance of lentigines. The results showed good clearance with no adverse events and good subject satisfaction in patients with skin type II-III. Additional studies need to be conducted on darker skin types. The histopathologic findings demonstrate that the picosecond 730 nm laser produces excellent selectivity for pigment with minimal disruption of the dermal-epidermal junction and may therefore reduce healing times and the risk of adverse events.
PMID: 34402537
ISSN: 1096-9101
CID: 5006352

Clinical and histologic evaluation of a fractional radiofrequency treatment of wrinkles and skin texture with novel 1-mm long ultra-thin electrode pins [Case Report]

Kauvar, Arielle N B; Gershonowitz, Amikam
BACKGROUND:Fractional radiofrequency (RF) microneedling technologies have shown effectiveness in treating skin laxity and wrinkles. We report the first experience using a novel device with 1-mm long ultrathin electrodes that utilizes a smooth RF-assisted ablation mode. OBJECTIVE:To evaluate the safety and effectiveness of treatment with a fractional RF device using 1.0-mm long × 0.15-mm diameter ultrathin electrode tips for improvement of facial skin texture and wrinkles. METHODS AND MATERIALS: This was a prospective, open-label, intraindividual-controlled trial. Nine participants (mean age: 47.6, Fitzpatrick skin type II-IV, Fitzpatrick Elastosis Wrinkle Scale [FEWS] score: 3-6) underwent six treatment sessions with a fractional RF technology utilizing an array of 6 × 6 1-mm long ultrathin electrodes. Treatment effectiveness was assessed by FEWS and the Global Aesthetic Improvement Scale (GAIS). Safety and tolerance were evaluated. RESULTS:Three months after the sixth treatment session, blinded, investigator-assessed FEWS decreased from baseline 4.33 ± 0.67-3.33 ± 0.67 (p < 0.005); 88.9% of participants showed overall skin improvement using the physician-assessed GAIS, and all of the participants reported improvement in skin texture and wrinkles. Treatment was well tolerated, with no adverse events and no downtime. Histological analysis in a porcine model showed a fractional pattern of epidermal ablation and dermal coagulation with intervening zones of normal healthy tissue. These changes were followed by progressive epithelialization over a period of 13 days. CONCLUSION/CONCLUSIONS:The fractional RF technology with the novel 1.0 long × 0.15 mm ultrathin electrodes tips was effective in improving skin texture and wrinkles without impacting the participants' daily activities.
PMID: 34287975
ISSN: 1096-9101
CID: 4951172

Treatment of periorbital wrinkles using thermo-mechanical fractional injury therapy versus fractional non-ablative 1565 nm laser: A comparative prospective, randomized, double-arm, controlled study [Case Report]

Salameh, Fares; Daniely, Danny; Kauvar, Arielle; Carasso, Rafael L; Mehrabi, Joseph N; Artzi, Ofir
BACKGROUND:Non-ablative fractional laser is an effective modality for the treatment of periorbital wrinkling, one of the earliest signs of skin aging. Thermo-mechanical fractional injury (TMFI) therapy (Tixel®, Novoxel®, Israel) is an innovative technology that is now being used for facial skin rejuvenation. Our study compares the clinical results, side effects, and downtime profile between TMFI treatment and non-ablative fractional 1565 nm laser (ResurFX®, Luminis, Israel). METHODS:This was a prospective study of 68 patients (64 women, 4 men) with skin types I-VI in two medical centers (34 from Israel, 34 from the USA) that were randomized to receive either TMFI or NAFL treatment for periorbital wrinkling. Patients received 3-5 treatments, 3-5 weeks apart. Six months after the last treatment, the change in Fitzpatrick Wrinkling Classification System (FWCS) was calculated by three non-involved physicians and compared to pretreatment results. Side effects and downtime profiles were assessed in each group (including VAS pain assessment, time required to refrain from work and social activity, and time required for the resolution of redness, edema, and crusts.) RESULTS: A moderate improvement in periorbital wrinkling was demonstrated in both groups, with an average improvement of 1.6 ± 0.6 in FWCS in the TMFI group and an average improvement of 1.7 ± 0.8 in the NAFL group (p < 0.001). Postprocedural VAS score was 5.86 ± 2.3 in the NAFL group and 4.01 ± 2.6 in the Tixel® group. Approximately 80% of subjects returned to both work and social activities two days postprocedure. Crusts were reported by 52% of patients in the TMFI group, compared to 16% of patients in the NAFL group more than 48 hours postprocedure (p < 0.05). There were no statistically significant differences in the other parameters between the two groups. CONCLUSION/CONCLUSIONS:TMFI is an effective and safe modality for the treatment of periorbital wrinkling, with comparable results to the 1565 nm NAFL.
PMID: 34787919
ISSN: 1096-9101
CID: 5049182

Efficacy and Safety of High-Intensity, High-Frequency, Parallel Ultrasound Beams for Fine Lines and Wrinkles

Wang, Jordan V; Ferzli, Georgina; Jeon, Hana; Geronemus, Roy G; Kauvar, Arielle
BACKGROUND:Ultrasound energy has been used for cutaneous rejuvenation, including treatment of fine lines and wrinkles. Ultrasound waves of high intensity can induce thermal injury in the dermis, which causes tissue coagulation and remodeling. OBJECTIVE:To examine the safety and utility of a novel ultrasound device that uses high-intensity, high-frequency, parallel ultrasound beams to improve fine lines and wrinkles of the face and neck. MATERIALS AND METHODS:A prospective, multicenter, clinical study investigated the utility of this novel ultrasound device to improve fine lines and wrinkles. Sixty subjects were enrolled for single treatment to the face and neck. RESULTS:Fifty-eight subjects completed the study. The mean age was 58 years, and 87.9% were women. Fitzpatrick skin Types I to VI were represented. Assessments compared 12-week follow-up with baseline. Two blinded reviewers agreed in identifying pretreatment and post-treatment photographs for 78% of subjects. There was significant improvement of 1 to 3 Fitzpatrick Wrinkle and Elastosis Scale units in 86% of subjects. For investigator global improvement scores, 88% of subjects had improvement. Overall, 72% of subjects noted improvement, and the majority were satisfied. There were no device-related adverse events. CONCLUSION:Treatment with a novel ultrasound device that uses high-intensity, high-frequency, parallel ultrasound beams safely improved the clinical appearance of fine lines and wrinkles of the face and neck.
PMID: 34417390
ISSN: 1524-4725
CID: 5082782

Laser Therapy of Traumatic and Surgical Scars and an Algorithm for Their Treatment [Case Report]

Kauvar, Arielle N B; Kubicki, Shelby L; Suggs, Amanda K; Friedman, Paul M
BACKGROUND AND OBJECTIVES/OBJECTIVE:This paper describes the laser techniques available for the treatment of surgical and trauma scars and develops recommendations for an algorithmic-based treatment approach based on extensive clinical experience and published data. STUDY DESIGN/MATERIALS AND METHODS/METHODS:We reviewed the literature regarding laser treatment of surgical and traumatic scars and incorporated the clinical experience of the authors to develop an algorithm for the treatment of surgical and trauma scars. RESULTS:In order to develop treatment recommendations, scars were differentiated based on their clinical characteristics. Specific scar characteristics aid in determining the appropriate treatment strategy for different types of complex surgical and trauma scars. CONCLUSION/CONCLUSIONS:Laser therapy is first-line therapy for traumatic and surgical scars. The treatment approach should be guided by scar characteristics (e.g., anatomic location, type of injury, color, thickness, tension, scar age, and activity) and involves choosing the appropriate laser type and determining the benefit of combination therapy with surgical and nonsurgical treatment modalities to optimize treatment responses. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.
PMID: 31621930
ISSN: 1096-9101
CID: 4140592

Combination, sequential treatment using fractionated 1550 nm, fractionated 1927nm and picosecond 532nm lasers improves moderately severe photodamage in a single treatment session [Meeting Abstract]

Kauvar, A N; Singh, G
Background: There is great interest in achieving dramatic improvements in photodamage with minimal anesthesia requirements, minimal downtime and few treatment visits. We report our experience treating photodamage using a one session combination treatment procedure with sequential application of a fractionated 1550 nm, fractionated 1927nm and picosecond 532nm laser. Study Design/Materials and Method: Fifteen subjects with skin phototypes I-III and moderately severe photodamage underwent a single session combination laser treatment with follow-up visits at 1 month and long term follow-up visits ranging from 3 to 18 months. Topical anesthetic was applied for one hour prior to treatment (lidocaine 23%/tetracaine 7% for the face and lidocaine 7%/tetracaine 7% for the chest). A fractionated 1550nm laser (Solta Medical, Pleasanton, CA) was applied first, with pulse energies of 40-50mJ and 6-8% skin surface coverage. A fractionated 1927nm laser (Solta Medical, Pleasanton, CA) was applied second, with pulse energies of 10- 15mJ and 20% skin surface coverage. A 350 ps 532nm laser (Candela Corp, Wayland, MA) was then applied to the discrete pigmented lesions (lentigines and macular seborrheic keratoses). Cold air cooling was used during laser treatment. Subjects applied a moisturizer 2-3 times per day for a period of 4-5 days. Standardized 35mm digital photographs were obtained before treatment and at the follow-up visits. Blinded photographic analysis was performed using a quartile grading system, and physician and subject ratings were recorded using a Global Aesthetic Improvement Scale (GAIS).
Result(s): Subjects rated their discomfort during laser treatment as mild to moderate. All subjects experienced mild erythema and edema lasting 2-4 days, followed by 2-3 days of light exfoliation. There were no instances of crusting, vesiculation, hyperpigmentation, hypopigmentation or scarring. One hundred percent (15/15) of subjects achieved greater than 50% improvement and 80% (12/15) of subjects achieved 76-100% improvement in their photodamage after a single treatment session. All subjects were rated as much improved or very much improved by subjects and physicians. Improvement was evident at the 18-month follow-up visit.
Conclusion(s): One session of sequential, combination treatment using a fractionated 1550 nm, fractionated 1927nm and picosecond 532nm laser produced dramatic improvements in photodamage, including pigmented lesions, skin texture and fine wrinkling. This one session combination treatment is a low risk, minimal down time procedure that produces consistent results and high patient satisfaction
ISSN: 1096-9101
CID: 3751322

Successful Treatment of a Residual, Thick, Infantile Hemangioma in a Darker Phototype Pediatric Patient Using the 755 nm Long-Pulsed Alexandrite Laser

Feng, Hao; Kauvar, Arielle N B
PMID: 28406866
ISSN: 1524-4725
CID: 2528342

Laser Treatment of Professional Tattoos With a 1064/532-nm Dual-Wavelength Picosecond Laser

Kauvar, Arielle N B; Keaney, Terrence C; Alster, Tina
BACKGROUND:Picosecond-domain laser pulses improve the photomechanical disruption of tattoos. OBJECTIVE:This study evaluates the efficacy and safety of a novel, dual-wavelength, 1,064/532-nm, picosecond-domain laser for tattoo clearance. MATERIALS AND METHODS/METHODS:This was a prospective, self-controlled, clinical study of 34 subjects with 39 tattoos treated at 2 sites with an interval of 4.8 ± 1.6 weeks and up to 10 treatments (mean, 7.5). Blinded evaluation and investigator assessment of serial digital images was performed to evaluate treatment efficacy in the 36 tattoos that received at least 3 treatments. Investigators also assessed efficacy before each treatment visit up to 10 treatments. Safety and tolerability was evaluated for all 39 tattoos that underwent at least 1 treatment. RESULTS:Blinded evaluation demonstrated that lightening of tattoos was achieved in all subjects, with 86% (31 of 36 tattoos) showing at least a 50% clearance after 3 treatments. Adverse events were few and transient in nature. Patient satisfaction and treatment tolerability were high. CONCLUSION/CONCLUSIONS:Treatment of single-colored and multicolored tattoos with this novel 1,064/532-nm picosecond laser is highly safe and effective.
PMID: 28930792
ISSN: 1524-4725
CID: 3027112