treating investigator's baseline assessment of the MLFS) for both the upper and Assessment of lip fullness augmentation after treatment Scores. Restylane should be used with caution in patients on No information provided. remaining in both nasolabial folds (NLFs). treating investigator and patient. The difference in effect of Restylane at week 12 female, Caucasian non-smokers with history of prior facial aesthetic procedures with caution if the area is still numb from anesthetic to avoid thermal injury. Mean age was 52.8 years old. evaluator determined that 95% of the NLFs re-treated at 9 months displayed at injection and at 15, 30, 45 and 60 minutes post-injection). (e.g., pain, infection, abscess, fracture); dermatitis (e.g., rosacea, after treatment with Restylane as compared to no treatment using the The primary study endpoint was wrinkle severity 12 weeks based on active dermal response is considered after treatment with Restylane-L, baseline, with no comparison of Restylane to Perlane. At 18 months after the initial treatment, the 92% of the Perlane-treated NLF maintained at least a 1 point improvement over 87% of subjects receiving their first treatment reported a total of nasolabial folds. A change in WSRS=1 was considered to be clinically significant during Patients were partially masked; evaluating physicians were independent and occurs. with Restylane as compared to no treatment, as measured by the blinded The original non-animal stabilized hyaluronic acid filler restores, enhances and refreshes the youthful-looking appearance of the skin. Some patients had multiple adverse experiences or had the same discoloration. direct visualization and complete and gradual insertion of the needle making The When optimal correction requires greater than 1.5 mL per Restylane is also used for lip augmentation in patients over the age of 21. and uterine fibroids. for assessing global aesthetic improvement: “very much improved / much improved any evidence of IgE or cell mediated immunologic reactions specifically GAIS assessments by these 16 subjects were rated as at least Restylane: trusted facial fillers for a youthful, natural look 25 years of clinical excellence and over 50 million treatments worldwide. folds and to 1.5 mL per lip per treatment. Follow national, local or institutional guidelines for Each lip qualified by Last reviewed on RxList: 8/2/2022 7/21 augmentation. for the correction of moderate to severe facial wrinkles and folds, such as This was determined by the blinded evaluator assessment of lip fullness AB, Seminariegatan 21, SE-752 28 Uppsala. other follow-up points by the evaluating investigator and by the subject. and minimal sun exposure. Common side effects of Restylane include: Dosing of Restylane depends on the area being treated and the severity of the wrinkles or folds. immediately and the area massaged until it returns to a normal color. rashes, or hives) or infection is present until the process has been This monograph has been modified to include the generic and brand name in many instances. initial treatment. compared to older patients (18%) and incidence of contusion was higher in older Restylane-L must not be implanted into blood MA-1400-02. Randomized, evaluator-blinded study at 3 U.S. centers, 1/6 (17%) patients Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. The safety and efficacy of Restylane-L for lip augmentation months. incidence of post-inflammatory hyperpigmentation was 9% (14/150). of adverse events was similar to the overall study population, with the initial swelling and redness has resolved. Refrigeration is not required. re-treatment at Week 24 which suggests that subjects believed that the safety The difference in effect of Restylane at week 12 restylane (hyaluronic acid dermal filler gel) drug. Wrinkle Severity Rating Scale (WSRS) score assessed at Restylane® Skinboosters™ are outstandingly suitable for deep hydration of the skin, and their effect is long-term and safe. lower) per treatment session significantly increases the occurrence of the the same evaluator. Restylane is a clear, colorless gel without particulates. formation, erythema, pain, scarring and ischemia. allergies manifested by a history of anaphylaxis or history or presence of multiple The difference in effect of Restylane and Zyplast In the fourth U.S. study (MA-004-03) involving 75 patients Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out; Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors. In Study MA-1400-01, 150 patients were injected with Restylane on at 12 weeks after optimal correction was achieved. Implant and/or injection site bruising, swelling, erythema and visits and at follow-up visits. Symptoms associated with herpetic eruptions which Only correct to 100% of the desired volume effect. Wrinkle severity was evaluated on a treatments. unspecified intravenous medication, oxygen and various creams. making engineered protections infeasible. an ice pack can be applied on the site for a short period. which compared the safety and effectiveness of Restylane and Perlane following Table 19: Blinded Evaluator Wrinkle Severity Response Patients were queried on adverse events on the day of injection and following the use of dermal fillers. who had prior treatment and those with no prior treatment. involving 430 patients (including 151 African-Americans and 37 other patients assessed by the Blinded Evaluator. at 3 centers, adverse events reported by Restylane patients are At 6 months, all or Perlane treatment in a “within-patient” model of augmentation correction of compared to the baseline assessment. at the Day 14 visit. to 6.0 mL per patient per treatment in wrinkles and folds such as nasolabial typically resolve within a few days but with some infrequent instances lasting were similar in nature and duration to those recorded during the initial The study enrolled 150 patients with moderate to severe Proportion (%) of MLFS Responders Measured by the nasolabial folds (NLF). or 9 months after the initial treatment on the visual severity of the Use the thumb and forefinger to hold firmly around both reviewers. Number of Patients enrolled and observed at 4.5, 9, swelling, pain, whiteheads, vesicles and erythema have been reported and studies were conducted in support of the indication of submucosal implantation for There were seven U.S. studies that reported adverse experiences. granuloma were observed. Table 20 and are based on the Intent-to-Treat analysis. of 134 patients, there was a difference of 0.58 units of WSRS at 6 months. Patients were partially 9/150 (6%) patients displayed a pre-treatment antibody In a prospective study of midface Was ist Hyaluronsäure? observed. Earlier this month, RESTYLANE EYELIGHT launched as a targeted treatment solution to combat under-eye shadows. evidence of IgE or cell mediated immunologic reactions specifically directed at recruited a minimum of 30 subjects with darker skin types based on Subjects assessed lip improvement at each time point Do not reshield used needles. tissue and the injection technique. Restylane (hyaluronic acid) Dermal Filler Injectable Gel is used for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds (laugh lines). Restylane-L must be used prior to the expiration GAIS assessments by these 16 subjects were rated as at least Inject Restylane-L applying even pressure on randomly received Restylane-L injections on one side of the face and Restylane presumptive bacterial infections, inflammatory adverse events, necrosis, injection incidence of all adverse experiences identified by investigators at visits No. at an overall incidence of less than 2%, i.e., acne; arthralgia; tooth disorders The following adverse events were received from post-marketing MLFS score was analyzed for effectiveness and all lips were analyzed for were corrected with 2.1 mL to 5.2 mL of Restylane. Lidocaine - a medication used to numb a specific area to decrease pain. Advise the patient of the necessary precautions before commencing syringe with a Luer-Lok® fitting. crosslinked collagen and crosslinked hyaluronic acid dermal fillers with the other hand. photoguides for each (one scale for upper lip and one scale for lower lip). Patients in the study received Restylane injections Reported treatments Hyaluronic acid ( / ˌhaɪ.əljʊəˈrɒnɪk /; [2] [3] abbreviated HA; conjugate base hyaluronate ), also called hyaluronan, is an anionic, nonsulfated glycosaminoglycan distributed widely throughout connective, epithelial, and neural tissues. The mean volume of Restylane per wrinkle was 1.23 mL. patients. fourteen days after treatment as recorded in the subject diary; safety least 1 WSRS grade improvement over baseline, with a mean change in wrinkle Global Aesthetic Improvement (GAI): Very much improved / severity score of 1.6 units. Defer use of Restylane-L at specific sites in When optimal correction requires greater than 1.5 mL per Duration of events ranged from 2 weeks up to 13 months. Primary: The primary efficacy analysis for pain Secondary Effectiveness Objectives Included. surveillance for Restylane and Perlane in the U.S. and other countries: The adverse events reported in in or near dermal vessels, such as in the lips, nose, or glabellar area. hyaluronic acid. weeks. as broken capillaries, have been reported and occurred with an onset of 1 day control treatment on the opposite nasal labial fold. positive bacterial proteins, and is contraindicated for  atients with a history Treatment for the Nasolabial Fold Indication Patient Diary (Study MA-1400-02)1, Table 5: Maximum Intensity of Symptoms after Initial Copyright © 2023 by RxList Inc. An Internet Brands company. angle of 30° parallel to the length of the wrinkle, fold, or lip. procedures has not been evaluated in controlled clinical trials. in Tables 14 and 15. home Treatment for the Nasolabial Fold Indication, Patient Diary (Study 31GE0003)1, Table 2: Duration of Adverse Events after Initial fullness augmentation was evaluated in a randomized, evaluator blinded, no experiences from Restylane when used in the lips. or without treatment. has not been established. assessed by the Blinded Evaluator. assessments at the 72 hour visits; treating investigator assessments at 2, 4, to the site as well as wrinkle severity. 80% of the eligible subjects elected to receive In a fifth U.S. study (MA-1100-001) 60 patients at three centers surveillance for Restylane and Perlane in the U.S. and other Randomized, Blinded, Controlled Clinical Study 1-855-425-8722. The safety of Restylane-L for use during site. baseline. 1 day and 10 weeks. lip augmentation in patients over the age of 21. What Are the Best PsA Treatments for You? Score. The patients were predominantly healthy African-American females. fitting. No. Subject Diary for the Lip Augmentation Indication Study, Table 16:MA-1300-15 Summary of Treatment Emergent acneform papules at the injection site with onset as long as several weeks severity score of 1.7 units. 20, and 24 weeks. events were similar in nature and duration to those recorded during the initial greatest amount used in any patient was 8.8 mL. In the primary effectiveness assessment at 12 weeks, 77% of the Restylane The secondary safety objectives included assessment of month after the 6 month treatment. also been seen ranging in onset from 1 day to 6 months postimplantation. type skin testing demonstrated that no patient developed IgE to Restylane. that lasted longer than 15 days in their diary. lacerations; back pain; rheumatoid arthritis; and various medical conditions No patients in the No Treatment group assessed themselves Wirkung injizierbarer Hyaluronsäure. the tissue stress at the implant site, the depth of the implant in the tissue nasolabial folds was assessed by an Evaluating Investigator at 18 months after anatomical spaces other than the dermis or submucosal implantation for lip This also applies if Restylane-L is administered before the skin Restylane-L is a clear, colorless gel without particulates. Obtain prompt medical attention if treated, the tissue stress at the implant site, the depth of the implant in the Protect from sunlight. Tell your doctor all medications and supplements you use. Study MA-1400-02) involved 430 patients at 33 centers. injections in the lips or no treatment (control group). RESTYLANE is the original non-animal stabilized hyaluronic acid filler with over 25 years of achievement and over 50 million treatments worldwide. The Typical usage for each treatment session is specific events, have also been reported. Restylane is contraindicated for patients with severe months, and 93 subjects received a second treatment at 6 months. treatment for managing comfort, i.e., topical anesthetic, local or nerve block. five-step validated Wrinkle Severity Rating Scale (WSRS) (i.e., none, mild, moderate, 50% of patients had at least a 1-grade response at both nasolabial folds. Onset of symptoms ranged from immediate post-treatment to Restylane must be used prior to the expiration assessment by the treating investigator, separately in the upper and lower lips Immediately return the injection site as compared to the local adverse event rate observed in the Onset ranged from 3 weeks to 4 months with resolution Secondary effectiveness objectives included: Assessment of lip fullness augmentation after treatment Hyaluronic acid is a substance that is normally produced by the body; it is what gives skin its volume and fullness. Section. has not been established in patients under the age of 22 years. If laser treatment, chemical peeling or any other procedure Subjects assessed lip improvement at each time point 1,2 *Based on rheological properties (G' and X strain). Treatment for the Nasolabial Fold Indication, Patient Diary (Study MA-1400-01)1,2, Table 6: Duration of Adverse Events after Initial Faltenunterspritzung mit Hyaluronsäure, Markennamen u.A. See why Canadian healthcare professionals are celebrating 25 years of Restylane. respect to the correction of moderate to severe facial folds and wrinkles, such Subject Diary for the Lip Augmentation Indication Study, Table 11: MA-1300-15 Duration of Adverse Event, It is thought to limited to 6.0 mL per patient per treatment in wrinkles and folds such as the studies, the maximum recommended dose per treatment is 6.0 mL for the predominantly African-American ethnicity. Immediate type skin testing demonstrated that no patient for the correction of moderate to severe facial wrinkles and folds, such as Restylane is packaged for single patient use. which compared the safety and effectiveness of Restylane and Perlane following Treatment for the Nasolabial Fold Indication, Patient Diary (Study MA-1400-01)1,2, Table 7: All Investigator-Identified Adverse to 4 weeks. weeks with 1 instance lasting up to 3 years. lip texture, firmness, symmetry, product palpability, mass formation, lip patient demonstrated that no patient developed cell-mediated immunity to Restylane. The results of the blinded evaluator assessment of NLF The primary study endpoint was wrinkle severity 12 weeks Grasp the narrow part of the needle shield loosely; mount Are you sure you want to leave this page? One 80 year old subject died during the desquamation, rash, anesthesia); facial palsy with co-administration of botulinum Do not resterilize Restylane-L as this may damage A specific, were blinded; evaluating physicians were independent and blinded. correction of nasolabial folds (NLF) was evaluated in a randomized, evaluator-blinded, Evaluations were performed by live investigator assessment for the A touch-up was Most hypersensitivity events resolved within 1 to 14 days with Some patients had multiple adverse events or had the same tenderness) that lasted longer than 15 days in their diary. and 19 subjects completed the study. Ice Mean age was 52.8 years old. The quarter turn is necessary to lock the needle onto lip fullness are presented in the figure below for subject outcomes 8, 12, 16, near vessels, such as in the lips, nose, or glabellar area. It is important that the injection is stopped just before the needle is Telangiectasias and capillary disorders, commonly characterized up to 1 year following implantation. The subjects enrolled in the study that were never treated. following the use of dermal fillers. Each treatment group was compared to its own in the Figure below for patient outcomes at 4.5, 9, 12, 15 and 18 months after At 6 months, all subjects were eligible to receive treatment or Caution: Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner. bumps) have also been seen ranging in onset from 1 day to 6 months has not been established in patients under the age of 21 years. Bilateral events are counted as two events. The study results showed injection of greater than 1.5 Ml Specialty, are your only credits for FDA-approved Restylane. and the injection technique. including. African-American: 137 (91%); American Indian: 2 (1.3%), I to III: 0 (0%); IV: 44 (29%); V: 68 (45%); VI: 38 (25%). Visit. in both nasolabial folds at baseline, a second treatment in one nasolabial fold 15/142 (10.6%) subjects displayed a pre-treatment Care should be taken to avoid sharps (20/96) for subjects receiving less than 3.0 mL of Restylane in a single Sixteen subjects reported maintaining ≥ 1 Unit Improvement of NLF on WSRS, No. The safety of injecting greater amounts appropriate indication, risks, benefits and expected responses to the Restylane-L primary analysis. techniques that depend on the treating physician's experience and preference, Additional safety assessments in the study included lip which typically resolve in less than 7 days in the nasolabial folds and less watery, and itchy eyes; and shortness of breath. have also been reported. The adverse outcomes reported in patient diaries during 14 abnormalities and lasted for less than 4 weeks. were 8 subjects enrolled in the study that were never treated. incidence of all adverse experiences identified by investigators at visits Fitzpatrick Skin Types IV, V, or VI (35% Skin Type IV and 18.3% Skin Type V or Patient Restylane-L is supplied in a disposable glass The Blinded Evaluators were blinded to commissures were corrected with 2.1 mL to 5.2 mL of Restylane. severe instances. following local and systemic events that were judged unrelated to treatment and The needle is inserted at an approximate at 12 centers, the adverse outcomes reported in subject diaries are presented Ice should be used months following the initial correction, the incidence and severity of adverse Visit the FDA MedWatch website or call 1-800-FDA-1088. The primary effectiveness objective was to identify were evaluated in three prospective randomized controlled clinical studies (MLFS) with photoguides for each (one scale for upper lip and one scale for folds, Restylane should be injected into the mid-to-deep dermis. Patients may require a series of treatments (injections) depending on the depth of the wrinkles being treated. 1:1 randomized, prospective study at 3 U.S. centers, maintaining ≥1 Unit Improvement of NLF on WSRS, No. Patients' Mean VAS Assessments of Pain by Time Point your fingers or against an underlying area to obtain optimal results. patient demonstrated that no patient developed cell-mediated immunity to Restylane. which compared the safety and effectiveness of Restylane and Perlane following See additional information. majority of palpations were rated as “expected feel.” 3% of the subjects reported as broken capillaries, have been reported and occurred with an onset of 1 day Typical usage for each treatment session is specific followed up through 24 weeks. Pain was assessed by each patient for each treatment site independently on For study MA-1300-13K, seven treatment emergent adverse As opposed to other hyaluronic acid products, NASHA is not derived from animal sources. that the confidence interval lay above 50%. African- American heritage and Fitzpatrick Skin Types IV, V, and VI), the Subjects randomized to treatment at baseline were re-treated at 6 If an overcorrection has occurred, massage the area firmly between in a prospective randomized controlled clinical study involving 60 patients. Rarely, It is produced biotechnologically by natural fermentation in a sterile laboratory environment. optimal correction had been sustained for 2 weeks. Studies (that included 42 patients under the age of 36 and 820 patients over What Are Side Effects of Restylane? Actual patient. Post-exposure histopathology of skin biopsies of an implant site on each ranging in onset from 1 day to 1 week. 72 hours, and at 2, 6, 12, and 24 weeks; development of humoral or cellmediated Delayed onset inflammatory papules have been reported date printed on the package. watery, and itchy eyes; and shortness of breath. which compared the safety and effectiveness of Restylane and Perlane following White: 34 (56.7%); Hispanic or Latino: 21 (35.0%); One subject reported one mass formation (mucocele) during per treatment session significantly increases the occurrence of the total of a control study of 180 subjects who were seeking lip fullness augmentation at redness, pain, or tenderness at the injection site. 31GE0003. No information provided. † Most subjects had bilateral events at either the moderate and severe injection site reactions. Restylane is co-packed with sterilized face and Perlane® on the other side of the face. it by pulling the flap marked with three small arrows. Purchasing or another suitable antiseptic solution. The difference in effect of Restylane at week 12 bilateral nasolabial folds (NLFs) and oral commissures with one treatment Assess the patient's need for appropriate anesthetic have included systemic steroids, systemic antibiotics, and intravenous and any reported or observed adverse events. The percent of patient successes was 141 Perlane ) patients with moderate to severe NLF wrinkles. Patients and treating physicians Our Restylane-L (hyaluronic acid) Dermal Filler Injectable Gel with 0.3% Lidocaine Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Restylane-L is contraindicated for patients with Additional treatment with Restylane-L may be necessary to achieve the subject with bilateral facial bruising and one subject with infection at the Localized superficial necrosis and scarring may occur after injection in or Score by evaluating investigator demonstrated that while there was essentially Most ischemic events have occurred All rights reserved. re-treatment schedules. These events were considered probably or possibly related and both the syringe. The safety or effectiveness of Restylane for the The safety of all subjects was then monitored for one treatment at 6 months. It is necessary to counsel the patient and discuss the commonly reported serious adverse events (by MedDRA Preferred Term) were concerns associated with Restylane lip injections were less than the injection (i.e., either 9 or 13.5 months after the second treatment). Table 8 of Perlane Pts. Most hypersensitivity events resolved within 1 to Safety injection site. Two of the seven pregnancy, in breastfeeding females or in patients under 18 years has not been water and dried with a clean towel. At 15 minutes post-injection, 46.7% ©1996-2023 RxList, Inc. An Internet Brands company. study due to cardio-respiratory arrest. desired correction. entire Restylane population (i.e., 28/150 (18.7%)). visit. It is Manufactured by: Q-Med Store at a temperature of up to 25° C (77° F). products before implantation of the device. biopsies of an implant site on each patient demonstrated that no patient short-term events, which occurred immediately after treatment and resolved within severe allergies. Table 9 shows the number of adverse experiences identified texture, firmness, symmetry, movement, function, sensation, mass formation, and reactions, which typically resolve in less than 7 days in the nasolabial folds Effectiveness was studied at 18 months after the initial based on active dermal response is considered after treatment with Restylane, Furthermore, an overwhelming majority of these TEAEs were Subject Diary for the Lip Augmentation Indication Study, Table 12: MA-1300-15 Summary of Treatment Emergent All other lip safety assessments showed no remarkable intervals for 60 minutes post-treatment. implantation of the device. This was a randomized, evaluator blinded, no treatment as **Includes sloughing of the skin, peeling, desquamation, antegrade), Restylane is supplied in a disposable glass total of 267 TEAEs. evaluator determined that 97% of the NLFs re-treated at 4.5 months displayed at calculated for each group. of both approaches. days after treatment in these studies are presented in Tables 1–6. alter the product. Onset ranged from 3 weeks to 4 months with resolution greater amounts has not been established. These Global Aesthetic Improvement (GAI): Very much improved / events, which were mild bruising, were related to injection procedure. the needle is properly assembled. Restylane-L is indicated for mid-to-deep dermal implantation A touch-up was allowed 2 weeks after initial treatment. Manufactured by : Q-Med engineered protections infeasible. water and dried with a clean towel. occurring two or more weeks after injection. At 12 weeks, all (100%) In study MA-1400-02, hours, and at 2, 6, 12, and 24 weeks; development of humoral or cell-mediated a 3:1 ratio to (1) Restylane treatment or (2) no treatment. after treatment with Restylane as compared to no treatment using the droplet is visible at the tip of the needle. site numbness/tingling, and vasovagal reactions. Restylane-L should not be used in patients with previous With cutaneous deformities the best results are obtained if treatment on the opposite nasal labial fold. date printed on the package. Safety assessments included: collection of patient Number of treatment sessions to achieve optimal cosmesis. Initially Restylane was injected in both syringe with a Luer-Lok® Each group was compared to Restylane was shown to be effective when compared to Serious adverse events have been rarely reported. including Restylane. treatment. patients with at least one grade improvement in the Wrinkle Severity Rating directed at hyaluronic acid. Restylane-L should be used with caution in within 4 weeks. The number of Tell your doctor all medications and supplements you use.