An interventional study of Alcarisa (hyaluronic acid filler) in Mid Face Volume Deficit, sponsored by Espad Pharmed. Recruiting at 2 sites in Iran. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Espad Pharmed · Not applicable, Interventional, and Treatment
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.
Espad Pharmed is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Undergoing or planning to undergo cosmetic treatments in the near future during the study, such as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: Baseline, 4 weeks after injection
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Intervention (day 0)
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
Time frame: at 4, 12, and 24 weeks after injection
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
Time frame: 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).
Time frame: Immediately after injection; 4, 12, and 24 weeks after injection
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2025 to primary completion in Apr 2025, 3 months.
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Espad Pharmed