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NCT Number: NCT07126912

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

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.

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Key information

Conditions

Mid Face Volume Deficit

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Research and Training in Skin Disease and Leprocy, Tehran, Tehran Province, Iran

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

Alcarisa (hyaluronic acid filler)

Device

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.

Primary outcomes

  1. At least one-grade reduction in Midface volume deficit scale (MFVDS)

    Time frame: Baseline, 4 weeks after injection

    At least a one-grade reduction from baseline in Midface volume deficit scale (MFVDS), as assessed by an independent physician based on photographs, where 0 represents no volume deficit and 5 represents severe volume deficit

Secondary outcomes

  1. At least a one-grade reduction in Midface volume deficit scale (MFVDS)

    Time frame: Baseline, 12 and 24 weeks after injection

    At least a one-grade reduction from baseline in Midface volume deficit scale (MFVDS) as assessed by an independent physician based on photographs, where 0 represents no volume deficit and 5 represents severe volume deficit

  2. Depth of the right and left nasolabial folds

    Time frame: 4,12, and 24 weeks after injection

    Depth of the right and left nasolabial folds, measured using standard frontal facial photographs taken with the Visioface device and analyzed via CSI software

  3. Surface area of the right and left nasolabial folds

    Time frame: 4,12, and 24 weeks after injection

    Surface area of the right and left nasolabial folds, measured using standard frontal facial photographs taken with the Visioface device and analyzed via CSI software

  4. Volume of the right and left nasolabial folds

    Time frame: 4,12, and 24 weeks after injection

    Volume of the right and left nasolabial folds, measured using standard frontal facial photographs taken with the Visioface device and analyzed via CSI software

  5. Pain severity during injection

    Time frame: Intervention (day 0)

    evaluated using the Visual Analogue Scale (VAS) from 0 to 10, where 0 indicates no pain at all and 10 indicates the maximum imaginable pain

  6. Participants satisfaction

    Time frame: at 4, 12, and 24 weeks after injection

    Participants' satisfaction assessed using the Visual Analogue Scale (VAS) from 0 to 10, where 0 represents complete dissatisfaction and 10 represents complete satisfaction

  7. Assessment of midface area improvement

    Time frame: at 4, 12, and 24 weeks after the injection

    Assessment of midface area improvement, based on the Global Aesthetic Improvement Scale (GAIS) as judged by the investigator compared to baseline, where 0 means the condition has been worsened and 4 represents excellent improvement

  8. Safety assessment by evaluation of adverse events (AEs)

    Time frame: Immediately after injection; 4, 12, and 24 weeks after injection

    All observed or reported adverse events immediately after injection, as well as 4, 12, and 24 weeks after injection, should be mentioned along with the severity grade (mild = 1, moderate = 2, and severe = 3).

Sponsors and collaborators

Lead sponsor

Espad Pharmed

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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