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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcarisa (hyaluronic acid filler, produced by Espad Pharmed Co.) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Research and Training in Skin Disease and Leprocy | Recruiting | Tehran | Tehran Province | 1416613675 | Iran |
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before/after clinical trial
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|
| 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) |
| 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 |
| 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 |
| Orchid Pharmed, Medical Department | Recruiting | Tehran | Tehran Province | 19947-66411 | Iran |
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