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1.
J Cosmet Dermatol ; 22(5): 1545-1553, 2023 May.
Article in English | MEDLINE | ID: mdl-36645338

ABSTRACT

BACKGROUND AND OBJECTIVES: This feasibility study describes the effects of Nano-pulse stimulation™ (NPS™) technology using the CellFX™ System on acne vulgaris of the back with the objectives of demonstrating safety and effectiveness. The CellFX System applies nanosecond pulses of electrical energy to induce highly localized regulated cell death (RCD) in the cellular structures of the targeted zone with no thermal effect on the tissue and negligible effects on surrounding non-cellular components. STUDY DESIGN/MATERIALS AND METHODS: Seventeen subjects were enrolled at two sites with thirteen subjects completing treatment. Three 7 X 7 cm regions containing at least five bacne lesions each were identified, one region treated with the CellFX across three treatment sessions, the second region treated as a sham using microneedle tip placement without delivering energy, and the third as an untreated control. RESULTS: CellFX-treated areas showed an average reduction of acne lesions of 82% by 90 days post-last procedure. Acne improvement was observed in 100% of CellFX-treated regions compared to 39% improvement in Sham regions and 31% improvement in the control regions. The most common skin effects were erythema and hyperpigmentation observed in 23% and 92% of the subjects, respectively, at the last timepoint. No serious adverse events were reported. CONCLUSIONS: CellFX is a safe and effective procedure for clearing back acne.


Subject(s)
Acne Vulgaris , Low-Level Light Therapy , Humans , Treatment Outcome , Acne Vulgaris/therapy , Acne Vulgaris/pathology , Skin/pathology , Low-Level Light Therapy/methods , Erythema
2.
Plast Reconstr Surg Glob Open ; 10(5): e4306, 2022 May.
Article in English | MEDLINE | ID: mdl-35646496

ABSTRACT

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.

3.
J Cosmet Dermatol ; 21(4): 1448-1453, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35150194

ABSTRACT

BACKGROUND: Given differences in buttock versus thigh cellulite, collagenase clostridium histolyticum-aaes (CCH-aaes) injection technique may impact treatment effects at these sites. AIM: To evaluate efficacy and safety of 5 CCH-aaes injection techniques. METHODS: A phase 2A, open-label trial enrolled women with mild-to-severe cellulite (Clinician Reported Photonumeric Cellulite Severity Scale) on both buttocks or thighs. CCH-aaes 0.84 mg was administered as 12 injections in each of two buttock or two thigh treatment areas (total dose, 1.68 mg) during three treatment sessions (Days 1, 22, 43). On Day 1, women were sequentially assigned to: Technique A = shallow injection/3 aliquots; Technique B = shallow injection/1 aliquot; Technique C = deep injection/1 aliquot; Technique D = deep and shallow injections/5 aliquots; or Technique E = shallow injection/4 aliquots. Change from baseline in Hexsel Cellulite Severity Scale (CSS) depression depth (range, 0 [no depressions] to 3 [deep depressions]) was assessed at Day 71. Safety was evaluated via adverse events. RESULTS: Sixty-three women with buttock (n = 31) or thigh (n = 32) cellulite received ≥1 CCH-aaes dose. For buttock cellulite, CCH-aaes injection Technique A resulted in the greatest baseline-adjusted improvement in CSS score on Day 71 (least-squares mean, 1.17-point improvement). For thigh cellulite, CSS score improvement was greatest with Technique D (least-squares mean, 1.40-point improvement). CCH injection Techniques A, D, and E were associated with more favorable safety profiles than Techniques B and C. CONCLUSION: Different CCH-aaes injection techniques are required with buttock (Technique A) versus thigh (Technique D) cellulite to optimize treatment outcomes.


Subject(s)
Cellulite , Microbial Collagenase , Buttocks , Cellulite/drug therapy , Female , Humans , Injections, Intralesional , Microbial Collagenase/adverse effects , Thigh , Treatment Outcome
4.
Dermatol Surg ; 47(5): 649-656, 2021 05 01.
Article in English | MEDLINE | ID: mdl-33840781

ABSTRACT

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.


Subject(s)
Cellulite/drug therapy , Microbial Collagenase/therapeutic use , Antibodies, Neutralizing/blood , Double-Blind Method , Female , Humans , Injection Site Reaction/etiology , Microbial Collagenase/adverse effects , Microbial Collagenase/immunology , Middle Aged , Patient Satisfaction , Treatment Outcome
5.
J Drugs Dermatol ; 18(12): 1268-1272, 2019 Dec 01.
Article in English | MEDLINE | ID: mdl-31860216

ABSTRACT

INTRODUCTION: Acne vulgaris (AV) is a common skin disorder that may result in long-lasting acne scars. Techniques such as delivering fractional radiofrequency (RF) energy through miniature pins or needles have been utilized to manage active acne and acne scars. Skin restoration through dermal remodeling, neo-collagenesis, neo-elastogenesis, and epidermal re-newal are typical results of such treatments. METHODS: 15 subjects suffering from acne received 3 sessions of facial treatments, 3-4 weeks apart, using a fractional RF device with 24 pins tip of 2500µm in length. The treatment's safety and efficacy were evaluated up to 6 months after the last treatment. RESULTS: Facial photos and classifications of active acne, acne scars, and overall skin appearance demonstrated improve-ments in follow-up visits compared to baseline. No significant or unexpected adverse events were detected. CONCLUSION: The current study supports the safety and efficacy of the fractional RF treatment modality for acne condition. J Drugs Dermatol. 2019;18(12):1268-1272.


Subject(s)
Acne Vulgaris/therapy , Cicatrix/therapy , Cosmetic Techniques , Radiofrequency Therapy/methods , Acne Vulgaris/complications , Adolescent , Adult , Cicatrix/etiology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Radiofrequency Therapy/adverse effects , Treatment Outcome , Young Adult
6.
Dermatol Surg ; 44(1): 75-83, 2018 Jan.
Article in English | MEDLINE | ID: mdl-28562435

ABSTRACT

BACKGROUND: Calcium hydroxylapatite (CaHA) microspheres suspended in a carrier gel is an opaque dermal filler that has been used to provide immediate volume correction in the dorsal hands. OBJECTIVE: To assess the safety and effectiveness of CaHA for the correction of volume loss in the hands up to 12 months. MATERIALS AND METHODS: This multicenter, controlled, single-blind study (NCT01832090) included 114 subjects randomized 3:1 to CaHA treatment and untreated control groups. Effectiveness was assessed by blinded investigators using the validated Merz Hand Grading Scale (MHGS). Subject-reported improvement was assessed using the Global Aesthetic Improvement Scale. Effects of treatment on hand function were also assessed. RESULTS: A total of 75% of subjects achieved ≥1-point improvement on the MHGS (p < .0001) at 3 months (primary end point); this response was generally maintained through 12 months. Proportions of subjects reporting improvement ranged from 98% (3 months) to 86% (12 months). There were no clinically significant differences between control and CaHA-treated subjects in any hand function measure. Adverse events were generally expected, minor, short-lived, injection-related, and similar to those observed in previous CaHA clinical studies. CONCLUSION: Treatment with CaHA results in significant improvement in the appearance of the dorsal hand and is well tolerated.


Subject(s)
Dermal Fillers/administration & dosage , Durapatite/administration & dosage , Hand , Skin Aging/drug effects , Adult , Aged , Dermal Fillers/adverse effects , Durapatite/adverse effects , Esthetics , Female , Gels , Humans , Male , Microspheres , Middle Aged , Single-Blind Method
7.
J Cosmet Laser Ther ; 19(4): 190-198, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28328287

ABSTRACT

BACKGROUND: Non-thermal laser therapy in dermatology, is a growing field in medical technology by which therapeutic effects are achieved by exposing tissues to specific wavelengths of light. OBJECTIVES: The purpose of this review was to gain a better understanding of the science behind non-thermal laser and the evidence supporting its use in dermatology. METHODS: A group of dermatologists and surgeons recently convened to review the evidence supporting the use of non-thermal laser for body sculpting, improving the appearance of cellulite, and treating onychomycosis. RESULTS: The use of non-thermal laser for body sculpting is supported by three randomized, double-blind, sham-controlled studies (N = 161), one prospective open-label study (N = 54), and two retrospective studies (N = 775). Non-thermal laser application for improving the appearance of cellulite is supported by one randomized, double-blind, sham-controlled study (N = 38). The use of non-thermal laser for the treatment of onychomycosis is supported by an analysis of three non-randomized, open-label studies demonstrating clinical improvement of nails (N = 292). CONCLUSIONS: Non-thermal laser is steadily moving into mainstream medical practice, such as dermatology. Although present studies have demonstrated the safety and efficacy of non-thermal laser for body sculpting, cellulite reduction and onychomycosis treatment, studies demonstrating the efficacy of non-thermal laser as a stand-alone procedure are still inadequate.


Subject(s)
Cosmetic Techniques/instrumentation , Esthetics , Laser Therapy/statistics & numerical data , Lasers, Solid-State/therapeutic use , Evidence-Based Medicine , Female , Humans , Lasers, Semiconductor/therapeutic use , Male , Onychomycosis/therapy , Treatment Outcome
8.
Aesthet Surg J ; 36(3): 335-43, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26879299

ABSTRACT

BACKGROUND: Treatment of cellulite using a 1440-nm YAG wavelength laser with side-firing fiber has proven safe and effective, lasting at least 6 months. OBJECTIVES: The authors evaluate the safety and efficacy of a single, subdermal procedure to treat the underlying structure of cellulite for at least 1 year. METHODS: Fifty-seven patients underwent a 3-step cellulite treatment with a 1440-nm Nd:YAG laser with a side-firing fiber and temperature-sensing cannula. Efficacy was measured by the blinded evaluators to distinguish baseline photos from those taken at 12 months posttreatment, with results on a 5-point, 2-category ordinal photonumeric scale when comparing baseline photos to 12 months posttreatment. Subject and physician satisfaction was assessed based on completion of a satisfaction survey. Adverse events (AE) were recorded throughout the study. Twelve month data were analyzed and compared to 6 month data. RESULTS: Evaluators chose baseline photographs 97% on average from 6 (-1, +2) months and 91% from the 12 (-3, +2) months posttreatment photographs. At 6 (-1, +2) months, the average improvement score was 1.7 for dimples and 1.1 for contour irregularities. At 12 (-3, +2) months, the average improvement score was 1.4 for dimples and 1.0 for contour irregularities. The average satisfaction score for the physician was 5.6 and the patient was 5.3 on a 6-point scale. CONCLUSIONS: A single, 3-step, minimally invasive laser treatment using a 1440-nm Nd:YAG laser, side-firing fiber, and temperature-sensing cannula to treat the underlying structure of cellulite proved to be safe and maintained effectiveness at least 1 year post treatment. LEVEL OF EVIDENCE 2: Therapeutic.


Subject(s)
Cosmetic Techniques/instrumentation , Laser Therapy/instrumentation , Lasers, Solid-State/therapeutic use , Subcutaneous Fat/surgery , Adult , Catheters , Female , Follow-Up Studies , Hot Temperature , Humans , Laser Therapy/adverse effects , Lasers, Solid-State/adverse effects , Middle Aged , Patient Satisfaction , Photography , Surveys and Questionnaires , Time Factors , Treatment Outcome , United States , Young Adult
9.
J Clin Aesthet Dermatol ; 8(10): 21-6, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26557215

ABSTRACT

Retinoids and alpha hydroxy acids differ in mechanism of action for treatment of photodamage, but concurrent use may produce a synergistic effect by combining retinoid-induced normalization of cellular differentiation with alpha hydroxy acid-induced exfoliation (in hydrophilic areas) and enhanced dermal and epidermal hydration. A recent bioengineered molecule, ethyl lactyl retinoate (alpha hydroxy acid retinoid conjugate), is the first to deliver alpha hydroxy acids and retinoids together in a hydrolysis-based time-released fashion. This could improve efficacy while minimizing irritation commonly associated with retinoid use. An eight-week clinical study was conducted to examine the efficacy and tolerability of this formulation; 25 women aged 54.1 ±8.9 years (mean ± SD) with moderate-to-severe photodamage (as determined by physician investigators using the Glogau Wrinkle Scale) employed a twice-daily regimen of cleanser (7.8% 1-lactic acid, 2% salicylic acid) and anti-aging serum (0.1% alpha hydroxy acids-retinoids, 6.5% 1-lactic acid) with concurrent use of sun protection factor 50+ sunscreen as needed. Longitudinal analysis of study data revealed statistically significant improvement in photodamage, dryness/flaking, dyschromia, and global appearance at eight weeks. All study products were well-tolerated throughout. Investigators concluded that the alpha hydroxy acid retinoid conjugate is a safe and effective topical therapy for moderate-to-severe photodamage, warranting further study, (clinicaltrials.gov, NCT02422836, https://clinicaltrials.gov/ct2/show/NCT02422836?term=NCT02422836).

10.
Dermatol Clin ; 32(1): 51-9, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24267421

ABSTRACT

Cellulite is a prevalent, multifactorial, condition that is extremely recalcitrant to a wide array of treatments. This article discusses patient characteristics, selection, and the vast armamentarium in the treatment of cellulite.


Subject(s)
Adipose Tissue/pathology , Subcutaneous Fat/pathology , Adipose Tissue/surgery , Administration, Topical , Humans , Lasers, Solid-State , Lipectomy/methods , Massage , Obesity , Photography , Retinoids/therapeutic use , Subcutaneous Fat/surgery , Treatment Outcome , Ultrasonic Therapy , Xanthines/therapeutic use
11.
Aesthet Surg J ; 33(4): 576-84, 2013 May.
Article in English | MEDLINE | ID: mdl-23536056

ABSTRACT

BACKGROUND: Historically, treatments for cellulite have not been able to address all of its physiological components and require multiple sessions. OBJECTIVE: The authors evaluate the safety and efficacy of a single, subdermal procedure to treat the underlying structure of cellulite. METHODS: Fifty-seven patients underwent a 3-step cellulite treatment with a 1440-nm Nd:YAG laser with a side-firing fiber and temperature-sensing cannula. Efficacy was measured by the ability of blinded evaluators to distinguish baseline photos from those taken at 3 and 6 months posttreatment, as well as their rating of the results on a 5-point, 2-category ordinal photonumeric scale when comparing baseline photos to those taken at 2, 3, and 6 months posttreatment. Patient and physician satisfaction was assessed based on completion of a satisfaction survey at 2, 3, and 6 months posttreatment. Adverse events (AE) were recorded throughout the study. RESULTS: At 6 months posttreatment, blinded evaluators rated at least a 1-point improvement in the appearance of cellulite in 96% of treated sites. Blinded evaluators were also able to correctly identify baseline versus posttreatment photos in 95% of cases. At least 90% of patients and physicians reported satisfaction with the results of treatment throughout 6 months. AE were mild in intensity and transient to treatment. CONCLUSIONS: A single, 3-step, minimally invasive laser treatment using a 1440-nm Nd:YAG laser, side-firing fiber, and temperature-sensing cannula to treat the underlying structure of cellulite proved to be safe and maintained effectiveness at least 6 months posttreatment. LEVEL OF EVIDENCE: 2.


Subject(s)
Adipose Tissue/radiation effects , Lasers, Solid-State/therapeutic use , Low-Level Light Therapy/methods , Obesity/radiotherapy , Adipose Tissue/physiopathology , Adult , Buttocks/physiopathology , Buttocks/radiation effects , Female , Follow-Up Studies , Humans , Middle Aged , Obesity/physiopathology , Patient Satisfaction/statistics & numerical data , Prospective Studies , Risk Assessment , Subcutaneous Fat/radiation effects , Thermosensing , Thigh/physiopathology , Thigh/radiation effects , Treatment Outcome , Young Adult
12.
J Clin Aesthet Dermatol ; 4(7): 25-34, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21779417
13.
J Drugs Dermatol ; 9(1): 16-21, 2010 Jan.
Article in English | MEDLINE | ID: mdl-20120420

ABSTRACT

BACKGROUND AND OBJECTIVE: The purpose of this study was to assess the efficacy and safety of a new fractional CO2 laser system for improving periorbital rhytids, tightening skin and elevating the eyebrow. MATERIALS AND METHODS: One hundred subjects with periocular wrinkles, tissue laxity, photoaged skin and moderate dermatochalasis of the face were prospectively treated one to four times in the periorbital area with a fractional CO2 laser device equipped with a scanning handpiece. Improvements in eyelid wrinkles, crow's feet and skin laxity were evaluated photographically by two blinded, independent observers. Eyebrow elevation was measured by the investigators. Subjects also scored satisfaction and tolerability. RESULTS: Approximately half of subjects achieved or maintained 26-50% improvement at 12 months. Nearly 40% of subjects maintained 1-2 mm elevation of the brow at six and 12 months after treatment. Subject satisfaction was high and the procedure was well tolerated. Mild-to-moderate erythema and edema persisted for up to three to four days. CONCLUSION: Treatment with a fractional CO2 laser device improves periorbital rhytids, tightens skin and elevates the eyebrow with minimal adverse effects.


Subject(s)
Cosmetic Techniques , Dermatologic Surgical Procedures , Eyebrows , Low-Level Light Therapy , Orbit/surgery , Rhytidoplasty/methods , Double-Blind Method , Female , Humans , Intraoperative Complications/epidemiology , Male , Middle Aged , Pain/epidemiology , Pain/etiology , Prospective Studies
14.
J Clin Aesthet Dermatol ; 3(12): 37-42, 2010 Dec.
Article in English | MEDLINE | ID: mdl-21203354

ABSTRACT

The present study investigated the use of a novel hyaluronic acid serum in combination with a cream comprising a mixture of human growth factors in conjunction with the micro laser peel procedure for skin rejuvenation. After preconditioning the face with the hyaluronic acid serum followed by the cream twice daily for one month, 15 female volunteers between 35 to 65 years of age with demonstrable facial wrinkling received a micro laser peel on the entire face using an erbium-doped yttrium aluminium garnet laser. Immediately following the laser procedure, the subjects applied the test products twice daily until the second laser peel one month later. Immediately following the second procedure, the subjects reapplied the test products for another month. In the large majority of subjects, erythema or edema, crusts or erosions, and transitory stinging or burning sensations after the micro laser peel were minimal or mild when the skin was treated with the serum followed by the cream. The micro laser peel in conjunction with the test products helped to significantly improve hyperpigmentation, wrinkles, and texture as compared to before treatment. This study with the micro laser peel device demonstrated that a novel hyaluronic acid serum combined with the human growth factor cream can be successfully used for skin rejuvenation in conjunction with light-to-medium invasive laser skin treatments.

15.
Lasers Surg Med ; 41(10): 779-84, 2009 Dec.
Article in English | MEDLINE | ID: mdl-20014254

ABSTRACT

BACKGROUND: Laser-assisted lipolysis with a medium pulsed 1,064 nm Neodymium:Yttrium-Aluminum-Garnet (Nd:YAG) system has been used since FDA approval in October 2006 [1]. Since then, this technology has been advanced to include an additional wavelength (1,320 nm) and an accelerometer designed to improve efficacy and safety. OBJECTIVE: (1) Evaluate the efficacy and safety of a sequentially firing 1,064 and 1,320 nm Nd:YAG laser device for lipolysis. (2) Evaluate the skin tightening effect by photographic documentation and skin measurements. (3) Assess new collagen formation by histologic and scanning electron microscopic studies. METHODS: Twenty subjects with unwanted local adiposities and skin laxity were enrolled. An Nd:YAG laser with sequentially firing wavelengths of 1,064/1,320 nm was used to treat localized areas of body adiposities. Digital photographs were taken before and after treatment, blinded independent observers graded improvement utilizing a percentile evaluation scale and subjects performed self-assessments. Five of the 20 subjects had the following tests performed: (1) Placement of 4 cmx4 cm square India Ink tattoos for measurement of skin tightening, (2) histology and electron microscopy, (3) biopsies prior to the procedure, 3 days and 1 month after the procedure to determine the presence of new collagen markers. RESULTS: Results showed reduction in localized adiposities with no adverse events from use of this device. Independent observers found 76-100% improvement in adiposities in 85% of subjects and 51-75% improvement in 15% of subjects. Of the subset of five patients, India Ink tattoo maps demonstrated an 18% decrease in surface area indicating a significant skin tightening effect. Histology by H&E, Methylene blue stains, and electron microscopy indicated new collagen formation compared to baseline. CONCLUSION: The 1,064 nm Nd:YAG and 1,320 nm Nd:YAG sequentially firing device with an accelerometer appears to be an effective and safe treatment for localized adiposities with the additional benefit of skin tightening.


Subject(s)
Adipose Tissue/radiation effects , Laser Therapy/instrumentation , Lipectomy/instrumentation , Skin/radiation effects , Collagen/ultrastructure , Cosmetic Techniques , Humans , Lasers, Solid-State , Pilot Projects , Treatment Outcome
16.
Dermatol Surg ; 33 Suppl 2: S122-6; discussion S126-7, 2007 Dec.
Article in English | MEDLINE | ID: mdl-18086049

ABSTRACT

OBJECTIVES: Each soft tissue filler product has its own unique profile in terms of adverse events. In this large-scale study, we investigated the safety profile of Radiesse, an injectable calcium hydroxylapatite (CaHA) implant, in treatment of nasolabial folds and other areas of the face. We also investigated the efficacy in a subset of the larger patient group. METHODS: After obtaining informed consent from the subjects, researchers injected CaHA at two treatment centers into 113 patients (100 women and 13 men, ranging in age from 26 to 78 years) for a variety of facial aesthetic applications over a period of 47 months. Seventy-five patients had a single injection session; 38 had multiple sessions. Most patients (102) received 1.0 mL of CaHA per session; 12 received 2.0 mL per session. Typically, CaHA was administered with a 27-gauge 0.5- or 1 1/4-in. needle. RESULTS: Safety. Of 113 patients, only 7 reported minor adverse events that were short-term and resolved within 1 month: transient ecchymosis (3), nongranulatomous submucosal nodules of the lip (2), and inflammation and edema (2). Efficacy. Efficacy ratings were performed for a subset of patients (n=41). On a scale of 1 to 5 (1=unsatisfactory; 5=excellent), the mean patient evaluation score for look and feel of the implant was 4.6; the mean physician scores for the look and feel of the implant were 4.5 and 4.6, respectively. During the 6-month follow-up visit, patients' mean ratings of the look and feel of the implant were 4.8 and 4.9, respectively. The physician's mean ratings for the look and feel of the implant were 4.5 and 4.9, respectively. CONCLUSIONS: In our study, CaHA performed well, with a favorable safety profile, high patient satisfaction (90% of patients reported very good or excellent results), and good durability. We are especially pleased with the low incidence of adverse events coupled with the favorable responses from the patients themselves due to longevity of correction.


Subject(s)
Biocompatible Materials/administration & dosage , Durapatite/administration & dosage , Face , Adult , Aged , Biocompatible Materials/adverse effects , Cosmetic Techniques , Durapatite/adverse effects , Female , Humans , Injections , Male , Microspheres , Middle Aged , Treatment Outcome
17.
J Drugs Dermatol ; 6(2): 140-2, 2007 Feb.
Article in English | MEDLINE | ID: mdl-17373171

ABSTRACT

Topical 5-aminolevulinic acid (ALA) and various light sources have been used to treat actinic keratoses and acne. Many of these regimens have required long incubation times due to the penetration qualities of ALA. This study tested the effectiveness of ALA in producing erythema when applied for 10 minutes after 2 passes of microdermabrasion versus an incubation time of one hour without microdermabrasion. The areas were treated with a 595-nm pulsed dye laser at 15 J/cm2 or 22.5 J/cm2. Photographs were taken at 24 and 48 hours after the treatment. The data indicated consistent superior results with the use of microdermabrasion prior to the application of ALA for 10 minutes. It appears that incubation of ALA with microdermabrasion for 10 minutes is as effective as, or more so than, ALA applied alone for one hour in producing erythema.


Subject(s)
Acne Vulgaris/therapy , Aminolevulinic Acid/administration & dosage , Keratosis/therapy , Laser Therapy , Photochemotherapy/methods , Administration, Topical , Adult , Erythema/etiology , Humans , Middle Aged , Time Factors
19.
J Am Acad Dermatol ; 54(2): 272-81, 2006 Feb.
Article in English | MEDLINE | ID: mdl-16443058

ABSTRACT

BACKGROUND: Cosmetic dermatologic procedures offer the promise of visible aesthetic enhancement with minimal risk. While in recent years the number of available procedures has proliferated, there are few objective methods for evaluating the relative quality of these procedures for particular indications or specific patients. OBJECTIVE: (A) To develop a simple, easy-to-use numerical rating scale to assess the quality of cosmetic surgical procedures on a range of parameters pertaining to clinical efficacy and patient satisfaction; (B) to statistically validate the discriminative value of this rating scale. METHODS: (A) Patient and physician interviews were performed to elicit a list of factors that may collectively characterize the clinical efficacy and patient tolerability of cosmetic dermatologic procedures. A 0-100 point rating scale was developed based on these factors, with the face-validity of this scale checked by a group of patients and physicians; (B) Statistical analysis of the questionnaire was performed by asking 15 expert cosmetic dermatologic surgeons to use it to rate 23 common cosmetic dermatologic procedures, and analyzing the results. RESULTS: (A) An easy-to-use scale was constructed to assess the quality of cosmetic dermatologic procedures by rating the associated cost, risk, time (procedure and recovery), discomfort, results, and longevity of benefit. A "physician adjustment factor" was used to further increase the relevance of this 0-100 point scale for specific patients; (B) Repeated-measures analysis of variations (ANOVAs) performed on the data from the survey of experts demonstrated that this scale can be used to discriminate between common dermatologic procedures. The differences in mean subscores and total scores among procedures grouped by anatomic site and target lesion-type were significant at the level of P < .05. LIMITATIONS: Patient preferences exogenous to the rating scale may increase or decrease the suitability of specific procedures. CONCLUSIONS: Common cosmetic dermatologic procedures are of uniformly high quality, as per expert ratings on a systematic measure. This quality rating scale appears statistically valid and robust, given that expert raters assigned similar ratings to the same procedures but mean ratings were different across procedures. In the future, this quality rating scale can be used to assess novel interventions, and to help dermatologic surgeons faced with patient concern to optimally select among alternative procedures for a given indication.


Subject(s)
Plastic Surgery Procedures , Botulinum Toxins, Type A/therapeutic use , Chemexfoliation , Cryosurgery , Decision Making , Dermabrasion , Humans , Laser Therapy , Lipectomy , Neuromuscular Agents/therapeutic use , Patient Satisfaction , Plastic Surgery Procedures/adverse effects , Plastic Surgery Procedures/economics , Surveys and Questionnaires
20.
Dermatol Clin ; 23(3): 383-91, v, 2005 Jul.
Article in English | MEDLINE | ID: mdl-16039421

ABSTRACT

Power liposuction seems to be a significant advance in the evolution of the liposuction procedure. It allows for a faster, less painful recovery for the patient and is less of a strain on the surgeon, increasing the precision of the procedure. Complications are less than those seen with traditional liposuction performed under local tumescent anesthesia. Because it is performed under local anesthesia, power liposuction allows for fine tuning of the body contours with the patient in the standing position, reducing the number of postoperative touch-ups.


Subject(s)
Adipose Tissue/pathology , Lipectomy/methods , Humans
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