Evaluation of Efficacy and Safety of Alcarisa (Hyaluronic Acid Produced by Espad Pharmed Co.) for Restoration of Mid-face Volume

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Alcarisa (hyaluronic acid filler)
  A single injection of Alcarisa filler with a maximum dose of 2 to 4 cc , was administered in the zygomaticomalar area, and if deemed appropriate by the physician, also in the anteromedial cheek and submalar areas on each side of the face.

Первичные конечные точки

• At least one-grade reduction in Midface volume deficit scale (MFVDS) [Срок оценки: Baseline, 4 weeks after injection]

Вторичные конечные точки (8)

• At least a one-grade reduction in Midface volume deficit scale (MFVDS) [Срок оценки: Baseline, 12 and 24 weeks after injection]
• Depth of the right and left nasolabial folds [Срок оценки: 4,12, and 24 weeks after injection]
• Surface area of the right and left nasolabial folds [Срок оценки: 4,12, and 24 weeks after injection]
• Volume of the right and left nasolabial folds [Срок оценки: 4,12, and 24 weeks after injection]
• Pain severity during injection [Срок оценки: Intervention (day 0)]
• Participants satisfaction [Срок оценки: at 4, 12, and 24 weeks after injection]
• Assessment of midface area improvement [Срок оценки: at 4, 12, and 24 weeks after the injection]
• Safety assessment by evaluation of adverse events (AEs) [Срок оценки: Immediately after injection; 4, 12, and 24 weeks after injection]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Иран · 2 центра

• Center for Research and Training in Skin Disease and Leprocy — Tehran
• Orchid Pharmed, Medical Department — Tehran

Идентификаторы

NCT: NCT07126912 · ALC.ESP.AF.IV.03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗