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Dermal Filler Injection

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181. Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea

to Baseline. Have used prescription topical (on the face) and/or oral antibiotics within 4 weeks prior to Baseline. Treatment with hormonal therapy or oral corticosteroids that is not on a stable dose and frequency for at least 12 weeks before Baseline and not stable throughout the study. Have had a facial procedure such as chemical peel, laser, microdermabrasion or injections with a dermal filler or neuromodulator within 8 weeks prior to Baseline. Have received photodynamic therapy or phototherapy

2018 Clinical Trials

182. A Study to Evaluate Subject Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment

fillers, or be planning to undergo any of these procedures at any time during the study Received temporary or semi-permanent facial or neck dermal filler injections (e.g. HA, calcium hydroxylapatite, L-polylactic acid) at any time prior to entry in the study Received mesotherapy, skin resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face or neck within 6 months prior to study enrollment Began use of any new over (...) /treatment Experimental: Juvéderm, BOTOX, BELKYRA, and SkinMedica BELKYRA may be administered by injections at least 1 month apart for up to 6 treatments from V1 to V6. From V7to V9, the subject will begin Facial filler injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) and SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer and Optional: Total Defence + Repair

2018 Clinical Trials

183. Submental Study (Sequential Treatment Approach)

of treatment. Subject has a history of treatment with CoolSculpting or KYBELLA® in the intended treatment area or has a history of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents). Subject has a history of treatment with radiofrequency, micro-focused ultrasound, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before the first treatment session. Subject has a history of treatment with botulinum toxin injections (...) Summary: Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area using multiple therapeutic tools. Condition or disease Intervention/treatment Phase Body Fat Disorder Device: The ZELTIQ System Drug: Kybella 20 MG in 2 ML Injection Phase 4 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 20 participants Allocation: Non-Randomized Intervention Model: Sequential Assignment Intervention Model

2018 Clinical Trials

184. Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline

hydrochloride (HCl). Mode of application: intradermal and/or supraperiosteal injection in the jaw Region. Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline during the initial injection and at the optional Week 48 re-treatment, and 1.5cc per jawline during the optional touch-up. Other Name: Radiesse® Injectable Dermal Filler with Lidocaine Delayed Treatment with Radiesse (+) Enrolled subjects will be randomized (2:1 allocation ratio) to either receive treatment (...) Injectable Dermal Filler with Lidocaine Outcome Measures Go to Primary Outcome Measures : Comparison of the responder rate between the treatment group and the untreated control group at Week 12, according to the Merz Jawline Assessment Scale (MJAS) [ Time Frame: Week 12 ] The MJAS is a 5-point scale. Secondary Outcome Measures : Descriptive summary of the FACE-Q satisfaction of the lower face and jawline for treated subjects at baseline and Week 12. [ Time Frame: Week 12 ] Average percent change

2018 Clinical Trials

185. Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction

Collaborators: U.S. Army Medical Research and Materiel Command Armed Forces Institute of Regenerative Medicine Information provided by (Responsible Party): Johns Hopkins University Study Details Study Description Go to Brief Summary: Although other methods (e.g., autologous fat transfer, dermal-/collagen-based fillers) for soft tissue reconstruction exist, each has distinct disadvantages leaving room for improvement in this treatment area. Investigators in the Elisseeff Laboratory (Johns Hopkins University (...) events to date. Each vial contains a 2 milliliter (mL) dose of the injectable AAT. This volume is similar to other commonly used injectable filler materials intended for soft tissue correction. Outcome Measures Go to Primary Outcome Measures : AAT efficacy for soft-tissue reconstruction in humans to restore volume in soft tissue defects of the trunk [ Time Frame: 6 months post-final injection ] Volume retention documented by pre-to-post injection volumetric changes as detected by 3-dimensional

2018 Clinical Trials

186. Pivotal Study to Evaluate the Effectiveness of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles

months Scar present in the areas to be treated Silicone injections in the areas to be treated Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices) Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment Active, chronic, or recurrent infection History of compromised immune system or currently being treated

2018 Clinical Trials

187. A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion

Date : August 21, 2018 Estimated Primary Completion Date : May 2019 Estimated Study Completion Date : May 2020 Arms and Interventions Go to Arm Intervention/treatment Experimental: Restylane Defyne injection with Restylane Defyne Device: Restylane Defyne hyaluronic acid dermal filler gel No Intervention: Control no-treatment control Outcome Measures Go to Primary Outcome Measures : Evaluate effectiveness of the treatment using the Galderma Chin Restrusion Scale [ Time Frame: 12 weeks after last (...) injection ] Effectiveness is defined as change from baseline on the Galderma Chin Retrusion Scale (GCRS; 0=no retrusion, 1=mild retrusion, 2=moderate retrusion, 3=substantial retrusion) Secondary Outcome Measures : Evaluate subject satisfaction using the FACE-Q [ Time Frame: 12 weeks after last injection ] Evaluate effectiveness of the treatment using the Galderma Chin Restrusion [ Time Frame: 24, 36, and 48 weeks after last injection ] Effectiveness is defined as change from baseline Assess overall

2018 Clinical Trials

188. Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences

of long-wear makeup (lipstick, lip liner, mascara, etc.) within 48 hours of study photographs and assessments. History of the following cosmetic treatments in the area(s) to be treated: Skin tightening procedure within the past year; Injectable filler of any type within the past: i. 12 months for Hyaluronic acid fillers (e.g. Restylane); ii 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse); iii. 24 months for Long-lasting Hyaluronic acid (Juvéderm Voluma) and Poly-L-Lactic acid fillers (e.g (...) Measures : The average SMAS depth in the eyebrow and lower face regions (cheeks, submental and submandibular) will be compared to quantitative measurements of eyebrow and submental/neck lift [ Time Frame: Day 90 post treatment ] SMAS = Superficial Musculo-Aponeurotic System Secondary Outcome Measures : Determine if there is a correlation between the Clinician Global Aesthetic Improvement Scale (CGAIS) at day 90 and 180 and average Superficial Musculo-Aponeurotic System (SMAS) and average dermal

2018 Clinical Trials

189. Calcium hydroxylapatite treatment of human skin: evidence of collagen turnover through picrosirius red staining and circularly polarized microscopy Full Text available with Trip Pro

Calcium hydroxylapatite treatment of human skin: evidence of collagen turnover through picrosirius red staining and circularly polarized microscopy Calcium hydroxylapatite (CaHA, Radiesse®) is a biocompatible, injectable filler for facial soft-tissue augmentation that provides volume to tissues, followed by a process of neocollagenesis for improved skin quality.To examine the effects of CaHA treatment on the molecular organization of collagen using a combination of picrosirius red staining (...) light microscopy provides evidence that subdermal injection of CaHA stimulates the formation of new collagen and dermal remodeling.

2018 Clinical, cosmetic and investigational dermatology

190. Durability, Behavior, and Tolerability of 5 Hyaluronidase Products. (Abstract)

Durability, Behavior, and Tolerability of 5 Hyaluronidase Products. Hyaluronic acid (HA) dermal fillers are commonly used in cosmetic dermatology. Due to differences in their physical characteristics, HA fillers demonstrate different sensitivity to degradation by hyaluronidase (Hase) because of HA concentration and differences in cross-linking. Similarly, there are differences in the activity of Hase products depending on source and concentration.The primary objective was to demonstrate (...) the differences in potency and activity of 5 Hase products when used to degrade 5 different HA products using a human in vivo model.The study subject was a healthy, consenting adult woman scheduled to undergo abdominoplasty. Skin to be excised was injected with 0.1 to 0.2 mL of each filler (10 injections each) leaving a visible lump. Immediately afterward, the HA lumps were injected with 4 IU of each Hase product every 2 minutes until the HA lumps were no longer visible or palpable. This procedure

2018 Dermatologic Surgery

191. Topographic anatomy of the infraorbital artery and its clinical implications for nasolabial fold augmentation. (Abstract)

Topographic anatomy of the infraorbital artery and its clinical implications for nasolabial fold augmentation. Understanding the topography of the blood vessels distributed around the nasolabial fold region is essential for ensuring the safety of dermal filler injections into the nasolabial fold. The purpose of this study was to provide anatomical information on the infraorbital artery distribution and its relationship with the facial artery for use in clinical procedures involving filler (...) injection during nasolabial fold augmentation.The infraorbital artery was investigated in the nasolabial fold region divided into zones I to XII based on clock-hour meridians centered on the infraorbital foramen. The running layers of the infraorbital artery and infraorbital nerve were also compared in the infraorbital foramen. Changes in the infraorbital artery were observed according to vascular dominance of the facial artery.The infraorbital artery was divided into three main branches, palpebral

2018 Plastic and reconstructive surgery

192. Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour

any treatment or behavior (e.g., unshaven facial hair; significant changes to dietary or exercise habits) during the subject's participation in the study that may affect the assessments of the submental area Exclusion Criteria: Grade 4 on SMSLG Grade 4 on AJFRS (Allergan Jowl Fat Rating Scale) BMI >35 kg/m2 History of, or current symptoms of dysphagia History of temporary, semi-permanent or permanent facial or neck dermal filler injections below the medial canthi at any time prior to treatment (...) : BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine BELKYRA® is injected into preplaytsmal fat tissue in the submental area. When the Investigator and subject agree that no further intervention is required to achieve the desired result, subjects will be eligible to receive VOLUMA™ treatment. VOLUMA™ is injected along the mandibular border. Drug: BELKYRA® BELKYRA® is injected into preplaytsmal fat tissue in the submental area. When the Investigator and subject agree that no further intervention is required

2018 Clinical Trials

193. A Single-Center Open-Label Study of 1064 nm Nd:YAG for Nonablative Skin Rejuvenation

purposes. Agree to not undergo any other procedure(s) for skin rejuvenation during the study, including but not limited to chemical peel, laser and light based device treatment, and home-use device treatment. Agree to not undergo any injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler during the study. Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course (...) of the study, and no plans to become pregnant or to father a child for the duration of the study. Exclusion Criteria: Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study. Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery. Prior injection to the face of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study

2018 Clinical Trials

194. Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles

the last 3 months A subject with a history of previous fat transfer, injectable calcium hydroxylapatite or poly-l-lactic acid to the study area within the past 6 months. A subject with a history of injection of hyaluronic acid dermal fillers in the study area within the past six months. Retinoid, hydroquinone, microdermabrasion, or chemical peel treatments to the face within one month prior to study participation or during the study. Current participation or participation within 30 days prior (...) potential defined as: 1. Having no uterus. 2. No menses for at least 12 months. Or; (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as: Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device (systemic birth control must have been started 30 days or more prior to enrolling) Intrauterine coil Bilateral tubal ligation Barrier method used with an additional form of contraception (e.g., sponge

2018 Clinical Trials

195. Dynamic Optical Coherence Tomography(D-OCT) Aging Study: A Preliminary Evaluation of Structural Differences Between Young and Aged Skin, Cellulite and Atrophic Acne Scars in Female Caucasian Subjects With Fitzpatrick Skin Types I-III Utilizing Non-invasiv

. These include products that address skin imperfections. This does not include a basic cleanser, moisturizer and sunscreen.(time frame 2 weeks) Chemical peel, microdermabrasion, dermaplaning, or microneedling (time frame 3 months) Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, Avage® or Differin® or other similar prescription drugs (time frame 3 months) Cosmetic injections (filler and/or toxins, i.e. Juvederm, Radiesse, Botox, etc.), non-ablative laser or fractional laser resurfacing (time frame 12 (...) (at the sponsor's discretion) by an independent physician expert. Measured at 300 and 500 microns depth. Blinded Independent Physician Assessor Grading of the D-OCT Images of Stratum Corneum Reflectivity [ Time Frame: Day 1 ] Grading (0 = absent to 3 = high). Blinded Independent Physician Assessor Grading of the D-OCT images of Upper Dermal Reflectivity [ Time Frame: Day 1 ] Grading (0 = absent to 3 = high). Blinded Independent Physician Assessor Grading of the D-OCT Images of Dermoepidermal Contrast [ Time

2018 Clinical Trials

196. Psychosocial predictors, assessment and outcomes of cosmetic interventions

such as botulinum injections, facelifts and breast implants. Following the events surrounding Poly Implant Prothèse (PIP) complications, the Department of Health called for evidence to support the clinical safety and regulation of cosmetic interventions. The aim of this systematic rapid evidence review was to locate, assess, describe and organise findings from the existing research literature to inform questions about: ? who requests or undergoes cosmetic procedures; ? whether any of their psychosocial (...) Background Interventions to enhance people’s cosmetic appearance are common across the UK, and the number of cosmetic interventions undertaken in the UK has increased substantially over the past decade. Cosmetic interventions range from non-surgical treatments such as tooth whitening and hair removal, to more complex surgical interventions such as botulinum injections, facelifts and breast implants. Following the events surrounding Poly Implant Prothèse (PIP) complications, the Department of Health

2013 EPPI Centre

197. A Phase IIa Open-Label Dose-Escalation Pilot Study Using Allogeneic Human Dermal Fibroblasts for Nasolabial Folds. (Abstract)

A Phase IIa Open-Label Dose-Escalation Pilot Study Using Allogeneic Human Dermal Fibroblasts for Nasolabial Folds. The correction of soft tissue contour defects and dermal atrophy is a growing area driven by medical and aesthetic need. Deterioration of the skin's appearance occurs as a result of age and trauma, such as surgery, infections, and acne. Typically, imperfections are treated with volume-correcting fillers. This study evaluated allogeneic human dermal fibroblasts (HDFs (...) ) for the treatment of nasolabial folds as an alternative strategy to improve the structure, texture, and quality of the skin.In this phase IIa study, a suspension of allogeneic HDF (2 × 10(6) cells/mL or 2 × 10(7) cells/mL) was injected intradermally along the nasolabial fold; line severity was assessed using a photographic scale.Mean investigator satisfaction was 7.4 (range 4.7-9.5) at 12 weeks and 7.6 (range 4.4-9.8) at 24 weeks. Subject satisfaction scores were 7.0 (range 0.1-10.0) at 12 weeks and 7.8 (range

2010 Dermatologic Surgery

198. Improving Voice Outcomes After Thyroid Surgery

VF medialization injection procedures, vocal fold reinnervation procedures, surgical thyroplasty, and then additional post-thyroplasty voice therapy sessions. The economic impact of assessing and managing individuals suffering a laryngeal disorder, in general, has been estimated to total between $179 million to $295 million in total annual direct costs. The average direct annual cost to such individuals was estimated to average between $577.18 to $953.21, with the proportion of direct claims

2013 American Academy of Otolaryngology - Head and Neck Surgery

199. Photopheresis, extracorporeal

modulation of arginine metabolism (20). In contrast to immunosuppressive therapy, ECP is not associated with any major side effects, including opportunistic infections. It has been postulated that the therapeutic effect of ECP operates presumably via the induction of regulatory T (Treg)-cells, without causing general immunosuppression. Using a murine contact hypersensitivity model, Maeda and colleagues demonstrated the induction of Treg-cells by an ‘ECP-like’ procedure (intravenous injection

2013 European Dermatology Forum

200. Breast prosthesis implantation for reconstructive and cosmetic surgery

and are associated with a lower rate of capsular contracture Coating Polyurethane sponge coating is available to cover a standard silicone gel-filled implant Silicone-filled breast implants have been classified into different generations (Peters et al 1996; IRG 1998): ? first generation implants (1963 to 1972) were characterised by firm gel fillers, thick silicone shells and a smooth surface. First generation implants are associated complications including gel bleed and capsular contracture (IRG 1998). ? Second (...) RAPID REVIEW OF BREAST PROSTHESIS IMPLANTATION FOR RECONSTRUCTIVE AND COSMETIC SURGERY 9 Table 4 Breast reconstruction procedures covered by the MBS or implant removal or adjustment procedures Item Number Descriptor Fee/Benefit Number of Claims 45539 BREAST RECONSTRUCTION (unilateral), following mastectomy, using tissue expansion - insertion of tissue expansion unit and all attendances for subsequent expansion injections (Anaes.) (Assist.) Fee: $1,071.20 Benefit: 75% or $803.40 2007: 1,068 2008

2013 Publication 80

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