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

Recruiting now · Not applicable

Conditions studied: Mid Face Volume Deficit

In brief

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.

Key facts

Study ID: NCT07126912
Run by: Espad Pharmed
People needed: 30
Starts: 2025-01-28
Expected to finish: 2025-10-30
Last updated by the study team: 2025-09-02

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Center for Research and Training in Skin Disease and Leprocy — Tehran, Tehran Province, Iran (enrolling)
Orchid Pharmed, Medical Department — Tehran, Tehran Province, Iran (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.