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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorEspad Pharmed

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Alcarisa (hyaluronic acid filler)

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators