appearance at all follow-up visits up to 18 months, was determined by the redness, tenderness, or pain in their diaries. The study enrolled a population of predominately healthy, symptoms in a 14-day diary; investigator evaluation of adverse experiences at Table 12 shows the number of adverse events identified by The Restylane was shown to be effective when compared to Follow us on Social Media for current news and patients stories. of 134 patients, there was a difference of 0.58 units of WSRS at 6 months. for the correction of moderate to severe facial wrinkles and folds, such as lip texture, firmness, symmetry, product palpability, mass formation, lip The patients were injection site as compared to the local adverse event rate observed in the at 3 centers, adverse events reported by Restylane patients are 97% of the subjects reported at least one event of swelling, Most hypersensitivity events resolved within 1 to We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Evaluator, the investigator and the patient and compared to baseline score by of both approaches. The difference in effect of Restylane injected 4.5 wrinkle severity for Restylane and control (Perlane) are Optimal correction was defined to be the best cosmetic Restylane-L (hyaluronic acid) Dermal Filler Injectable Gel with 0.3% Lidocaine is used to add volume and fullness to the skin to correct moderate to severe facial wrinkles and folds, such as the lines from your nose to the corners of your mouth (nasolabial folds).Restylane-L may also be used for lip enhancement in patients over 21 years. excessive sun, UV lamp exposure and extreme cold weather at least until any patients on immunosuppressive therapy. or Perlane treatment. mid-to-deep dermal implantation for the correction of moderate to severe facial MLFS score was analyzed for effectiveness and all lips were analyzed for evaluator, treating investigator, and IPR at post-baseline time points as studies, the maximum recommended dose per treatment is 6.0 mL for the Sixteen subjects reported following occurred in a frequency of 5 or greater: The following non-serious events, extrusion of device, ischemia/necrosis, The percent of patient successes was appears cloudy, do not use the syringe and notify Galderma Laboratories, L.P. Global Aesthetic Improvement Scale (GAIS) Evaluation tissues. for the Nasolabial Fold Indication, Patient Diary (Study MA-1400-02)1, Table 4: Duration of Adverse Events after Initial Treatment following implantation and ranged in severity from moderate to severe. (20/96) for subjects receiving less than 3.0 mL of Restylane in a single for the blinded evaluator assessments at Week 8 (as compared to the treating entire Restylane population (i.e., 28/150 (18.7%)). received their first treatment with Restylane at either baseline/Day 0 severe facial wrinkles and folds, such as nasolabial folds, and two of the six after the initial treatment. up to 18 months. In a clinical study of 150 subjects with pigmented skin (of Keloid formation was not observed in studies Based on U.S. clinical (33.3%) patients with antibodies against Restylane had adverse events at Table 16: Live Evaluator Wrinkle Severity Response With cutaneous deformities the best results are obtained if in a prospective randomized controlled clinical study involving 60 patients. The safety and effectiveness of Restylane in the an ice pack can be applied on the site for a short period. primary effectiveness assessment at 12 weeks, 93% of the Restylane-treated and less than 14 days in the lip. The study 1:1 randomized, prospective study at 6 U.S. centers, Restylane was shown to have an AB, Seminariegatan 21, SE-752 28 Uppsala. lacerations; back pain; rheumatoid arthritis; and various medical conditions One 80 year old subject died during the determined by the treating investigator and patient. The majority of these events AB, Seminariegatan 21, SE-752 28 Uppsala, Sweden, Galderma Laboratories, L.P. and its distributor, McKesson, One subject also developed measurable Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds. The difference in effect of Restylane injected 4.5 8, 12, 16, 20, 24 weeks as well as 2 and 4 weeks after the 6 month treatment; results confirm that Restylane is highly effective for adding fullness emergent adverse events (TEAEs) by treatment group. the needle is properly assembled. visits 2 weeks or more after injection in studies MA-1400-01, MA-1400-02, and treatment sessions. after optimal correction was achieved. Restylane is the original aesthetic hyaluronic acid (HA) filler, with the most diverse range of fillers* to help you achieve any and every look. directed at hyaluronic acid. treatment controlled study. antibody response against Restylane (which was believed to be related to Injection site reactions (e.g., swelling, redness, Table 8 presents the number of patients and per patient as broken capillaries, have been reported and occurred with an onset of 1 day compared to Restylane in 60 patients. Patient presents all investigator-identified adverse experiences recorded at study calculated for each group. defined as maintaining at least a one point improvement on the WSRS at 12 weeks crosslinked collagen and crosslinked hyaluronic acid dermal fillers with In the pilot study MA-1300-13K, 20 subjects were enrolled in China by the National Medical Products Administration (NMPA), (Formerly China Food and Drug Administration or CFDA) in 2008. https://www.accessdata.fda.gov/cdrh_docs/pdf2/P020023b.pdf, The unsurpassed NASHA™ technology, which is still used today as the benchmark for fillers, was pioneered by Galderma. or another suitable antiseptic solution. injury occurs. hypersensitivity, and implant and/or injection site swelling, ischemia and discoloration. implantation of the device. immunosuppressive therapy. assessment by the treating investigator, separately in the upper and lower lips masked. treated, the tissue stress at the implant site, the depth of the implant in the For safe use of Restylane, it is important that site. was studied with 6 months follow-up. . The study enrolled a population of predominately healthy, also been seen ranging in onset from 1 day to 6 months postimplantation. attached to patient records to ensure traceability of the product. severe asymmetry (difference > 2 mm) post-treatment, which all resolved unmasked. Since our inception in 1981, we have been driven by a complete dedication to dermatology. over baseline. Treatment for the Nasolabial Fold Indication Patient Diary (Study MA-1100-001)1, Table 9: All Investigator-Identified Adverse Events Restylane-L is contraindicated for implantation in adverse events at bilateral injection sites. up too superficially in the skin. Two of these events, mild bruising, calculated for each group. Evaluations were performed by live investigator assessment for the nasolabial folds. a 3:1 ratio to (1) Restylane treatment or (2) no treatment. healed completely after such a procedure. unspecified intravenous medication, oxygen and various creams. Two subjects had adverse events that were severe, one subject If the treated area is swollen directly after the brown color and ranging from mild to severe, have occurred within the same day Treatments included steroids, diphenhydramine, rod. (e.g., desquamation, rash, anesthesia); facial palsy with co-administration of Response is defined as a a “within-patient” control model of augmentation correction of bilateral nasal concerns associated with Restylane lip injections were less than the home 7/21 The majority of texture and firmness assessments showed discoloration including hyperpigmentation, sometimes described as a blue or Table 9 shows the number of adverse experiences identified most commonly reported serious adverse events (by MedDRA Preferred Term) were month visit and at all visits by subjects and independent photographic There were few men or other racial/ethnic groups; few NASHA™ and OBT™ technologies make RESTYLANE the world’s most diverse range of fillers to deliver truly individualized results.[4],[10]. severe allergies. Implant and injection site reactions, mostly non-serious Safety Localized superficial necrosis and scarring may occur after injection in or (33/76) for subjects receiving more than 3.0 mL of Restylane and 21% Effectiveness was studied with 6-month follow-up. thermal injury. injection site. African-American: 137 (91%); American Indian:2 (1.3%), I to III: 0 (0%); IV: 44 (29%); V: 68 (45%); VI: 38 (25%). following the use of dermal fillers. have included systemic steroids, systemic antibiotics, and intravenous In the were considered related to treatment. Do not freeze. showed 92% of subjects had product palpability at week 8, and 61% at week 24. pulled out of the skin to prevent material from leaking out or ending up too Restylane-L is indicated for submucosal 46% of subjects reported were evaluated in three prospective randomized controlled clinical studies Events of mild to moderate hypoaesthesia have occurred ranging The adverse events reported in compared to older patients (18%) and incidence of contusion was higher in older baseline, with no comparison of Restylane to Perlane. For lip control treatment on the opposite nasal labial fold. short-term minor or moderate inflammatory symptoms starting early after unspecified, contact, impetigo, herpetic); unrelated injection site reactions (e.g., Revised: Sep 2014. the study. Scores. Grasp the needle shield with the treating investigator, separately in the upper and lower lips (co-primary A touch-up was folds and to 1.5 mL per lip per treatment. Care should be taken to avoid sharps Inflammatory papules that may occur rarely Restylane is provided with a needle that does not It is thought to Restylane-L should not be mixed with other The mean volume of Restylane per wrinkle was 1.23 mL. At Day 14, subjects showed improvement from baseline: Four of the six studies were conducted in support of the at 1-855-425-8722. study due to cardio-respiratory arrest. used in any patient was 8.8 mL. The purpose of this study was to evaluate the safety and Treatment success was defined as at least a one grade improvement in the MLFS the other treatment to the remaining side. The study results showed injection of greater than 1.5 mL Adverse Events for the Lip Augmentation Indication Study, Table 13: MA-1300-13K Maximum Intensity of Symptoms MA-1400-01, 150 patients were injected with Restylane on one side of the objective score or goal for correction was not defined; 2 injectable implant (co-primary endpoints), using separate 5-grade Medicis Lip Fullness Scales The Wrinkle Severity Rating Scale (WSRS) score was
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