Mid Face Volume DeficitNCT07126912
Evaluation of Efficacy and Safety of Alcarisa (Hyaluronic Acid Produced by Espad Pharmed Co.) for Restoration of Mid-face Volume
A study testing Alcarisa (hyaluronic acid filler) in people with Mid Face Volume Deficit, run by Espad Pharmed at 2 sites in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Mid Face Volume Deficit
- What is being tested?
- Alcarisa (hyaluronic acid filler)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesIran
- Study dates
- 28 Jan 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Iran2 sites, 2 recruiting
- Recruiting
Center for Research and Training in Skin Disease and Leprocy
Tehran, Tehran Province, 1416613675
Alireza firooz, doctorate, 02188972220, firozali@tums.ac.ir
Alireza Firooz
- Recruiting
Orchid Pharmed, Medical Department
Tehran, Tehran Province, 19947-66411
Hamidreza Kafi, 98-21-43473000, Kafi.H@orchidpharmed.com
About this study
Official title: 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.
- Conditions
- Mid Face Volume Deficit
- Being tested
- Alcarisa (hyaluronic acid filler)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Alcarisa (hyaluronic acid filler) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 4 weeks after injection
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: Immediately after injection; 4, 12, and 24 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start28 Jan 2025
- Primary completion28 Apr 2025
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid Face Volume DeficitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- before/after clinical trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Espad Pharmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126912
- Sponsor's protocol ID
- ALC.ESP.AF.IV.03
- Status last verified
- Jul 2025
- First submitted
- 10 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07126912
- Acronym / sponsor ID
- ALC.ESP.AF.IV.03
- Conditions
- Mid Face Volume Deficit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Espad PharmedIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before/after clinical trial
| Arm | Type | Receives |
|---|---|---|
| Alcarisa (hyaluronic acid filler, produced by Espad Pharmed Co.) | Experimental | 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Alcarisa (hyaluronic acid filler, produced by Espad Pharmed Co.) |
Primary outcome
At least one-grade reduction in Midface volume deficit scale (MFVDS)
Time frame: Baseline, 4 weeks after injection
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
8 secondary outcomes
At least a one-grade reduction in Midface volume deficit scale (MFVDS)
Time frame: Baseline, 12 and 24 weeks after injection
Depth of the right and left nasolabial folds
Time frame: 4,12, and 24 weeks after injection
Surface area of the right and left nasolabial folds
Time frame: 4,12, and 24 weeks after injection
Volume of the right and left nasolabial folds
Time frame: 4,12, and 24 weeks after injection
Pain severity during injection
Time frame: Intervention (day 0)
Participants satisfaction
Time frame: at 4, 12, and 24 weeks after injection
Assessment of midface area improvement
Time frame: at 4, 12, and 24 weeks after the injection
Safety assessment by evaluation of adverse events (AEs)
Time frame: Immediately after injection; 4, 12, and 24 weeks after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Center for Research and Training in Skin Disease and Leprocy
Tehran, Iran
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcarisa (hyaluronic acid filler) in people with Mid Face Volume Deficit, run by Espad Pharmed at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At least one-grade reduction in Midface volume deficit scale (MFVDS) (time frame: Baseline, 4 weeks after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.