Alcarisa (hyaluronic acid) injections to restore mid-face volume

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Assessing a new injectable gel for improving mid-face volume

  This study is testing a new injectable gel to see if it can safely and effectively restore volume in the mid-face for adults who have lost fullness due to aging, comparing it to an existing treatment.

  Recruiting at 15 sites Phase 3 AbbVie · Birmingham, Alabama and 14 other locations · NCT06734351

• Skin changes after biostimulator (Sculptra) treatment seen with non-invasive imaging

  We will try Sculptra injections in women aged 45–65 with moderate-to-severe cheek wrinkles to see how their skin changes over three treatments using non-invasive imaging.

  Recruiting Galderma R&D · New York, New York · NCT07399028

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.