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

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.

Study Overview

• Status: Recruiting
• Conditions: Mid Face Volume Deficit
• Intervention / Treatment: Device: Alcarisa (hyaluronic acid filler)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran
  • Tehran Province
    • Tehran, Tehran Province, Iran, 1416613675
      • Recruiting
      • Center for Research and Training in Skin Disease and Leprocy
      • Contact: Alireza firooz, doctorate; Phone Number: 02188972220; Email: firozali@tums.ac.ir
      • Principal Investigator: Alireza Firooz
      • Sub-Investigator: Mansour Nasiri Kashani
      • Sub-Investigator: Azin Ayatollahi
      • Sub-Investigator: Saman Ahmadnasrollahi
      • Sub-Investigator: Ensiyeh Samadi
      • Sub-Investigator: Taraneh Yazdanparast
      • Sub-Investigator: Amir Houshang Ehsani
    • Tehran, Tehran Province, Iran, 19947-66411
      • Recruiting
      • Orchid Pharmed, Medical Department
      • Contact: Hamidreza Kafi; Phone Number: 98-21-43473000; Email: Kafi.H@orchidpharmed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcarisa (hyaluronic acid filler, produced by Espad Pharmed Co.); 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.	Device: Alcarisa (hyaluronic acid filler); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
At least one-grade reduction in Midface volume deficit scale (MFVDS)	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	Baseline, 4 weeks after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
At least a one-grade reduction in Midface volume deficit scale (MFVDS)	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	Baseline, 12 and 24 weeks after injection
Depth of the right and left nasolabial folds	Depth of the right and left nasolabial folds, measured using standard frontal facial photographs taken with the Visioface device and analyzed via CSI software	4,12, and 24 weeks after injection
Surface area of the right and left nasolabial folds	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	4,12, and 24 weeks after injection
Volume of the right and left nasolabial folds	Volume of the right and left nasolabial folds, measured using standard frontal facial photographs taken with the Visioface device and analyzed via CSI software	4,12, and 24 weeks after injection
Pain severity during injection	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	Intervention (day 0)
Assessment of midface area improvement	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	at 4, 12, and 24 weeks after the injection
Safety assessment by evaluation of adverse events (AEs)	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).	Immediately after injection; 4, 12, and 24 weeks after injection
Participants satisfaction	Participants' satisfaction assessed using the Visual Analogue Scale (VAS) from 0 to 10, where 0 represents complete dissatisfaction and 10 represents complete satisfaction	at 4, 12, and 24 weeks after injection

Collaborators and Investigators

• Sponsor: Espad Pharmed

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Actual): April 28, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: August 10, 2025
• First Submitted That Met QC Criteria: August 10, 2025
• First Posted (Actual): August 17, 2025

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: ALC.ESP.AF.IV.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No