Alcarisa (hyaluronic acid) injections to restore mid-face volume
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
NA · Espad Pharmed · NCT07126912
Doctors will try Alcarisa hyaluronic acid injections to restore mid-face volume in adults 30 to 65 with moderate to severe cheek volume loss.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Espad Pharmed (industry) |
| Locations | 2 sites (Tehran, Tehran Province and 1 other locations) |
| Trial ID | NCT07126912 on ClinicalTrials.gov |
What this trial studies
This interventional protocol delivers a single session of Alcarisa hyaluronic acid filler (2–4 cc) into the zygomaticomalar area, with optional injection of the anteromedial cheek and submalar regions as judged by the physician. Participants have standardized digital photographs taken before injection, immediately after, and at 4, 12, and 24 weeks to document changes. Physicians use predefined photographic measurements to rate efficacy and monitor safety, and participants report satisfaction at the same time points. The study follows an inclusion/exclusion framework that excludes people with known hypersensitivities, recent streptococcal disease, active infections or scarring at the injection site, bleeding or autoimmune disorders, and requires the ability to complete a six-month follow-up.
Who should consider this trial
Good fit: Adults aged 30–65 with moderate to significant mid‑face volume loss (MFVDS score 3–4) who can attend all study visits and agree to six months of follow‑up.
Not a fit: People with mild or very severe facial volume loss outside the study range, known allergy to filler components or lidocaine, active infection or scars in the injection area, recent streptococcal disease, or autoimmune/bleeding disorders are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, Alcarisa could provide a safe, single‑session option to restore cheek volume and improve facial appearance.
How similar studies have performed: Other hyaluronic acid fillers have been widely used and shown effectiveness and acceptable safety for mid‑face volume restoration, while this study collects product‑specific data for Alcarisa.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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: 1. Botulinum toxin type A injections below the zygomatic arch during the 6 months prior to study entry 2. Previous injections of temporary dermal fillers (e.g., bovine collagen, hyaluronic acid) in the facial area within 1 year prior to study entry 3. 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 this trial is running
Tehran, Tehran Province and 1 other locations
- Center for Research and Training in Skin Disease and Leprocy — Tehran, Tehran Province, Iran (RECRUITING)
- Orchid Pharmed, Medical Department — Tehran, Tehran Province, Iran (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mid Face Volume Deficit