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2.
Ophthalmic Plast Reconstr Surg ; 38(4): e113-e116, 2022.
Article in English | MEDLINE | ID: mdl-35323140

ABSTRACT

Orbital sarcoid is a rare entity and may be the first manifestation of systemic sarcoidosis. We report a case of orbital sarcoidosis where diagnosis was complicated by a history of lower eyelid blepharoplasty. The patient presented with progressive swelling of the left lower eyelid, which was assumed to be a late complication of her surgery. After failing multiple treatments, MRI orbits was obtained and revealed an enhancing lesion in the left orbit inseparable from the lacrimal gland and inferior oblique muscle. Biopsy showed noncaseating granulomatous inflammation, and the patient was eventually diagnosed with sarcoidosis.


Subject(s)
Blepharoplasty , Sarcoidosis , Blepharoplasty/adverse effects , Eyelids/pathology , Female , Humans , Orbit/pathology , Postoperative Complications/diagnosis , Sarcoidosis/complications , Sarcoidosis/etiology , Tomography, X-Ray Computed
3.
Aesthet Surg J ; 41(11): NP1675-NP1685, 2021 10 15.
Article in English | MEDLINE | ID: mdl-34351386

ABSTRACT

BACKGROUND: Rejuvenation of the under-eye area is a popular facial aesthetic treatment option. OBJECTIVES: This study evaluated the safety and effectiveness of VYC-15L for the correction of moderate or severe infraorbital hollowing. METHODS: This was a randomized, controlled, single-blind study with a primary endpoint defined as the proportion of participants with ≥1-grade improvement at Month 3 assessed by an evaluating investigator employing the Allergan Infraorbital Hollow Scale. Three-dimensional imaging was conducted to assess infraorbital volume up to Month 12. Procedure pain and injection-site responses (ISRs) were documented, and safety was monitored throughout the study. RESULTS: At Month 3, the difference between treatment (83.1%) and control (15.6%) was 67.5% (95% CI = 52.9 to 82.0, P < 0.0001). 3D imaging showed a mean volume increase from baseline of 0.733 mL (left) and 0.777 mL (right) at Month 12. Mean pain scores were ≤1.7 (scale of 0 to 10). Most ISRs with initial treatment were mild/moderate and resolved in ≤1 week, including tenderness (49.5%), bruising (42.7%), and swelling (41.7%). Thirty-four participants had treatment-emergent adverse events (TEAEs), of which 14 (10.3%) had treatment-related TEAEs, including bruising (3.8%) and swelling/edema (2.9%), which resolved in ≤2 weeks. Three participants had swelling/edema starting >30 days posttreatment; 2 resolved in ≤4 days, 1 by 45 days. No treatment-related serious AEs were reported. CONCLUSIONS: VYC-15L was safe and effective for the correction of moderate or severe infraorbital hollowing and lasted through 1 year.


Subject(s)
Cosmetic Techniques , Dermal Fillers , Skin Aging , Adult , Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Humans , Hyaluronic Acid/adverse effects , Prospective Studies , Single-Blind Method , Treatment Outcome
4.
Plast Reconstr Surg ; 145(1): 45-58, 2020 01.
Article in English | MEDLINE | ID: mdl-31609882

ABSTRACT

BACKGROUND: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation in clinical development. A phase 2 dose-ranging study identified an optimal dose and demonstrated efficacy with a median duration of 24 weeks. METHODS: In two phase 3, multicenter, randomized, double-blind, placebo-controlled studies (SAKURA 1 and SAKURA 2), subjects with moderate or severe glabellar lines at maximum frown were assigned randomly to receive placebo or 40 U of DAXI. Glabellar lines were evaluated at least every 4 weeks for at least 24 weeks until severity returned to baseline (≤36 weeks). RESULTS: Overall, 609 subjects were enrolled (DAXI, n = 405; placebo, n = 204). DAXI was significantly more effective than placebo in achieving the primary efficacy outcome (≥2-point improvement in glabellar line severity at maximum frown at week 4 according to both investigator and subject ratings): 73.6 percent versus 0.0 percent (SAKURA 1), and 74.0 percent versus 1.0 percent (SAKURA 2) (both p < 0.0001). Composite investigator and subject ratings of maximum frown after DAXI treatment showed that glabellar line severity of none or mild was maintained for a median of 24.0 weeks (SAKURA 1) and 23.9 weeks (SAKURA 2), and glabellar line severity did not return to baseline levels for a median of 27.7 and 26.0 weeks, respectively. DAXI was generally well tolerated, with the most common adverse events related to DAXI treatment being headache (SAKURA 1, 7.0 percent; SAKURA 2, 5.9 percent) and injection-site pain (5.0 percent and 2.4 percent, respectively). CONCLUSIONS: Results from both studies were highly consistent. DAXI may offer a prolonged duration of response (median, ≥24 weeks) and is generally well tolerated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.


Subject(s)
Botulinum Toxins, Type A/pharmacology , Injections , Neuromuscular Agents/pharmacology , Skin Aging/drug effects , Adult , Botulinum Toxins, Type A/administration & dosage , Double-Blind Method , Female , Forehead , Humans , Male , Middle Aged , Neuromuscular Agents/administration & dosage , Young Adult
5.
Aesthet Surg J ; 39(2): 187-200, 2019 01 17.
Article in English | MEDLINE | ID: mdl-29762642

ABSTRACT

Background: OnabotulinumtoxinA and hyaluronic acid are effective in improving moderate to severe facial wrinkles and folds, with treatment selection traditionally based upon facial area. Objectives: This prospective, multicenter, open-label, crossover study evaluated physician-rated efficacy and patient-rated outcomes following moderate to severe facial wrinkles and folds treatment with onabotulinumtoxinA and hyaluronic acid. Methods: 152 subjects (25-65 years) were randomized (1:1) to a treatment-sequence of onabotulinumtoxinA/hyaluronic acid or hyaluronic acid/onabotulinumtoxinA, with initial treatment administered on day 1 and 6 additional visits: week 2 (touch-up); week 4 (crossover); week 6 (touch-up); and weeks 8, 12, and 24 (follow-up). Results: Between 92% and 100% of subjects in each treatment-sequence group exhibited at least some improvement from baseline at each study visit in the Physician Aesthetic Improvement Scale and the Objective Observer and Patient Global Assessments of Improvement, with no significant between-sequence differences. Subjects reported looking 3 to 6 years younger at each visit, with significant improvements in glabellar, lateral canthal, and horizontal forehead lines, and nasolabial folds. Treatments were well tolerated. Conclusions: OnabotulinumtoxinA and hyaluronic acid provide clinically meaningful improvements as rated by physicians, objective observers, and subjects, with clinical synergy in aesthetic effects and duration of response regardless of treatment administration order in subjects seeking improvement in moderate to severe facial wrinkles and folds.


Subject(s)
Cosmetic Techniques/adverse effects , Dermal Fillers/administration & dosage , Neuromuscular Agents/administration & dosage , Patient Satisfaction , Skin Aging/drug effects , Adult , Botulinum Toxins, Type A/administration & dosage , Botulinum Toxins, Type A/adverse effects , Cross-Over Studies , Dermal Fillers/adverse effects , Esthetics , Female , Forehead , Humans , Hyaluronic Acid/administration & dosage , Hyaluronic Acid/adverse effects , Male , Middle Aged , Nasolabial Fold , Neuromuscular Agents/adverse effects , Prospective Studies , Treatment Outcome
6.
Dermatol Surg ; 41(6): 693-701, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25973559

ABSTRACT

BACKGROUND: Little information exists on how facial aesthetic treatments are incorporated into aesthetic regimens. OBJECTIVE: Assess the evolution of facial aesthetic treatments in patients receiving long-term continuous onabotulinumtoxinA treatment. METHODS: This international retrospective chart review included patients with ≥5 years of continuous onabotulinumtoxinA treatments including ≥1 glabellar lines treatment/year. Charts were reviewed for facial areas treated, number of treatments, doses/treatment visit, concomitant aesthetic procedures, and onabotulinumtoxinA-related adverse events. RESULTS: Data were collected from 5,112 onabotulinumtoxinA treatment sessions for 194 patients over an average of 9.1 years. Dosing was relatively stable over time; however, interinjection intervals increased. Glabellar lines' treatment temporally preceded crow's feet lines and forehead lines' treatment. A majority of patients (85%) also received treatment with fillers. Cumulative increases in onabotulinumtoxinA treatments occurred over time and by facial area corresponding with increases in treatments with injectable fillers, energy-based devices, and prescription topical creams. The longer the patients were treated, the younger they perceived themselves to look. Rates of adverse events were low. CONCLUSION: OnabotulinumtoxinA treatment evolved over time, coinciding with growth of the facial aesthetics market. Additional treatment modalities were added as complements to onabotulinumtoxinA. Long-term continuous onabotulinumtoxinA injections are an important component of contemporary facial aesthetic treatment regimens.


Subject(s)
Botulinum Toxins, Type A/administration & dosage , Cosmetic Techniques/trends , Neuromuscular Agents/administration & dosage , Skin Aging/drug effects , Adult , Aged , Aged, 80 and over , Botulinum Toxins, Type A/adverse effects , Combined Modality Therapy/trends , Cross-Sectional Studies , Dermatologic Agents/therapeutic use , Drug Administration Schedule , Esthetics , Eye , Female , Forehead , Humans , Male , Middle Aged , Neuromuscular Agents/adverse effects , Patient Satisfaction , Retrospective Studies , Self Concept , Surveys and Questionnaires , Time Factors
7.
Plast Reconstr Surg ; 134(6): 1197-1201, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25415089

ABSTRACT

Vascular occlusion causing blindness is a rare yet greatly feared complication of the use of facial aesthetic fillers. The authors performed a review of the aesthetic literature to ascertain the reported cases of blindness and the literature reporting variations in the vascular anatomy of the human face. The authors suggest a small but potentially helpful addition to the accepted management of the acute case. Cases of blindness, mostly irreversible, from aesthetic filler injections have been reported from Asia, Europe, and North America. Autologous fat appears to be the most frequent filler causing blindness. Some cases of partial visual recovery have been reported with hyaluronic acid and calcium hydroxylapatite fillers. The sudden profusion of new medical and nonmedical aesthetic filler injectors raises a new cause for alarm about patient safety. The published reports in the medical literature are made by experienced aesthetic surgeons and thus the actual incidence may be even higher. Also, newer injectors may not be aware of the variations in the pattern of facial vascular arborization. The authors present a summary of the relevant literature to date and a suggested helpful addition to the protocols for urgent management.


Subject(s)
Biocompatible Materials/adverse effects , Blindness/etiology , Cosmetic Techniques/adverse effects , Embolism/chemically induced , Hyaluronic Acid/adverse effects , Subcutaneous Fat/transplantation , Tissue Transplantation/adverse effects , Biocompatible Materials/administration & dosage , Blindness/drug therapy , Blindness/prevention & control , Durapatite/administration & dosage , Durapatite/adverse effects , Embolism/complications , Humans , Hyaluronic Acid/administration & dosage , Hyaluronoglucosaminidase/therapeutic use , Injections, Intradermal
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