A Single-arm, Before- After Clinical Study to Evaluate the Safety and Efficacy of Alcarisa Hyaluronic Acid Filler (Espad Pharmed Co.) for Restoration of Mid-face Volume
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- At least one-grade reduction in Midface volume deficit scale (MFVDS)
研究概览
简要总结
Mid-face volume loss is a factor affecting beauty that makes people feel uncomfortable about themselves. The purpose of this study is to evaluate the efficacy and safety of Hyaluronic Acid injection with the brand name Alcarisa®, manufactured by Espad Pharmed Co., for treatment of this condition.
The intervention consisted of a single treatment session, injecting 2 to 4 cc of gel into the zygomaticomalar area, and, if deemed by the physician, into the anteromedial cheek and submalar areas on each side of the face.
The patient underwent digital photography at the following time points: before injection, immediately after injection, and at 4, 12, and 24 weeks post-injection. The physician then used these photographs to evaluate the product's efficacy and safety based on predefined measurements. In addition, participant satisfaction was assessed at the same time intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 30 to 65 years
- •Individuals with moderate to significant mid-face volume loss (score 3 to 4) based on changes in MFVDS (in cases of asymmetry between the two sides of the face, the more severe side will be considered)
- •Ability to comply with visit schedules and study procedures
- •Signed the informed consent form and agreed to 6-month follow-up
排除标准
- •History of Type I hypersensitivity reactions or anaphylaxis
- •Known allergy or sensitivity to any components of the filler, lidocaine, or to proteins from the HA-producing microorganisms (Streptococci)
- •History of hypertrophic or keloid scarring, or bleeding disorders in the injection area
- •Active inflammatory processes, infections, lesions (malignant or benign), or scars in the injection area
- •History of streptococcal diseases (such as recurrent sore throat or acute rheumatic fever) in the past 6 months
- •History of autoimmune/immunodeficiency diseases, or use of immunosuppressive drugs during the 6 months prior to or during the study
- •History of surgery or trauma in the injection area within the past 6 months
- •Use of antiplatelet drugs within 72 hours prior to treatment, or anticoagulants within 2 weeks prior to or during treatment
- •Use of drugs that reduce or inhibit hepatic metabolism (e.g., cimetidine, beta-blockers) due to the presence of lidocaine
- •Pregnancy, breastfeeding, or plans to become pregnant in the near future during the study
- •Undergoing or planning to undergo cosmetic treatments in the near future during the study, such as:
- •Botulinum toxin type A injections below the zygomatic arch during the 6 months prior to study entry
- •Previous injections of temporary dermal fillers (e.g., bovine collagen, hyaluronic acid) in the facial area within 1 year prior to study entry
- •Use of calcium hydroxyapatite, poly-L-lactic acid, or permanent fillers (e.g., silicone), or fat injections in the injection area at any time before or during the study
结局指标
主要结局
At least one-grade reduction in Midface volume deficit scale (MFVDS)
时间窗: Baseline, 4 weeks after injection
At least a one-grade reduction from baseline in Midface volume deficit scale (MFVDS), as assessed by an independent physician based on photographs, where 0 represents no volume deficit and 5 represents severe volume deficit
次要结局
- At least a one-grade reduction in Midface volume deficit scale (MFVDS)(Baseline, 12 and 24 weeks after injection)
- Depth of the right and left nasolabial folds(4,12, and 24 weeks after injection)
- Surface area of the right and left nasolabial folds(4,12, and 24 weeks after injection)
- Volume of the right and left nasolabial folds(4,12, and 24 weeks after injection)
- Pain severity during injection(Intervention (day 0))
- Participants satisfaction(at 4, 12, and 24 weeks after injection)
- Assessment of midface area improvement(at 4, 12, and 24 weeks after the injection)
- Safety assessment by evaluation of adverse events (AEs)(Immediately after injection; 4, 12, and 24 weeks after injection)
- At least a one-grade reduction in Midface volume deficit scale (MFVDS)(Baseline, 12 and 24 weeks after injection)
- Depth of the right and left nasolabial folds(4,12, and 24 weeks after injection)
- Surface area of the right and left nasolabial folds(4,12, and 24 weeks after injection)
- Volume of the right and left nasolabial folds(4,12, and 24 weeks after injection)
- Pain severity during injection(Intervention (day 0))
- Participants satisfaction(at 4, 12, and 24 weeks after injection)
- Assessment of midface area improvement(at 4, 12, and 24 weeks after the injection)
- Safety assessment by evaluation of adverse events (AEs)(Immediately after injection; 4, 12, and 24 weeks after injection)