Actively Recruiting
Evaluation of Efficacy and Safety of Alcarisa (Hyaluronic Acid Produced by Espad Pharmed Co.) for Restoration of Mid-face Volume
Led by Espad Pharmed · Updated on 2025-09-02
30
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Efficacy and Safety of Alcarisa (Hyaluronic Acid Produced by Espad Pharmed Co.) for Restoration of Mid-face Volume
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 30 to 65 years
- Moderate to significant mid-face volume loss (score 3 to 4 on the Midface Volume Deficit Scale)
- Ability to follow visit schedules and study procedures
- Signed informed consent and agreed to 6-month follow-up
You will not qualify if you...
- History of Type I hypersensitivity or anaphylaxis
- Allergy or sensitivity to filler components, lidocaine, or proteins from HA-producing microorganisms
- History of hypertrophic/keloid scarring or bleeding disorders in the injection area
- Active inflammation, infections, lesions, or scars in the injection area
- Streptococcal diseases in past 6 months
- Autoimmune or immunodeficiency diseases or use of immunosuppressants within 6 months prior or during study
- Surgery or trauma in injection area within past 6 months
- Use of antiplatelet drugs within 72 hours prior or anticoagulants within 2 weeks prior or during treatment
- Use of drugs that reduce hepatic metabolism (e.g., cimetidine, beta-blockers)
- Pregnancy, breastfeeding, or plans to become pregnant during study
- Recent or planned cosmetic treatments including botulinum toxin below zygomatic arch within 6 months, temporary dermal fillers within 1 year, or permanent fillers or fat injections at any time before or during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Center for Research and Training in Skin Disease and Leprocy
Tehran, Tehran Province, Iran, 1416613675
Actively Recruiting
2
Orchid Pharmed, Medical Department
Tehran, Tehran Province, Iran, 19947-66411
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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