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Tests treatment safety and results for Mid Face Volume Deficit
Official title Evaluation of Efficacy and Safety of Alcarisa (Hyaluronic Acid Produced by Espad Pharmed Co.) for Restoration of Mid-face Volume
ClinicalTrials.gov ID: NCT07126912
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 65
You may be able to join if
- 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...
- Ability to comply with visit schedules and study procedures
- Signed the informed consent form and agreed to 6-month follow-up
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tehran, Tehran Province, Iran
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tehran, Tehran Province, Iran. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.