Nasolabial Fold CorrectionNCT07102537
Evaluation of Efficacy and Safety of Intella Dermal Filler in Moderate to Severe Nasolabial Folds
A study testing Hyaluronic acid combined with calcium hydroxyapatite injection in people with Nasolabial Fold Correction, run by Espad Pharmed at 1 site in Iran.
Trial summary
This single-arm, before-and-after clinical trial evaluated the safety and efficacy of Intella, a combined CaHA and HA dermal filler manufactured by Espad Pharmed Darou Co., for the correction of moderate to severe nasolabial folds. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasolabial Fold Correction
- What is being tested?
- Hyaluronic acid combined with calcium hydroxyapatite injection
- 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
- 1 siteIran
- Study dates
- 2 Jan 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have moderate to severe nasolabial folds based on the Allergan scale.
- Participants must be able to comply with the visit schedule and study procedures.
- Participants must have signed the informed consent form and agreed to the 6-month follow-up
Who cannot join
- History of type 1 hypersensitivity reactions or anaphylaxis.
- Previous allergy or sensitivity to filler components or lidocaine.
- History of hypertrophic or keloid scar formation or bleeding disorders in the nasolabial area.
- Presence of active inflammatory processes, infection, or lesions (malignant/non-malignant) in the nasolabial area.
- History of autoimmune diseases/immunodeficiency or use of immunosuppressive drugs within 6 months prior to or during the study.
- Use of antiplatelet drugs within 72 hours prior to treatment and anticoagulants within 2 weeks prior to or during treatment.
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- Pregnancy, breastfeeding, or planning pregnancy in the near future during the study.
- Use of cosmetic treatments in recent months or plans to undergo such treatments in the near future during the study, including:
- Botulinum toxin type A injections below the zygomatic arch within 6 months prior to study entry.
- Non-permanent dermal filler injections (e.g., bovine collagen, hyaluronic acid) in facial areas within 1 year prior to study entry.
- Use of calcium hydroxyapatite, poly-L-lactic acid, or permanent fillers (e.g., silicone) in facial areas at any time before or during the study.
- Deep skin peeling procedures such as chemical peeling, laser, dermabrasion, radio frequency within 6 months prior to study entry.
- Superficial skin peeling within 6 weeks prior to study entry.
- Other reasons that, according to the investigator's judgment, make the patient unsuitable for study participation (e.g., uncertainty about patient cooperation).
Trial locations and contacts
1 site in 1 country.
Iran1 site
Orchid Pharmed, Medical Department
Tehran, Tehran Province, 19947-66411
About this study
Official title: A Single-Arm, Before- After Clinical Study to Evaluate the Safety and Efficacy of Intella Dermal Filler (Produced by Espad Pharmed Darou Co.) for Correction of Moderate to Severe Nasolabial Folds
This single-arm, before-and-after clinical trial evaluated the safety and efficacy of Intella, a combined CaHA and HA dermal filler manufactured by Espad Pharmed Darou Co., for the correction of moderate to severe nasolabial folds. The study involved 30 female participants with a mean age of 48.8 years (range 34-64 years).
After obtaining written informed consent and confirming eligibility criteria, 1 to 2 ml of Intela filler was injected subcutaneously into the bilateral nasolabial fold areas by a dermatologist. Assessments were performed immediately before, immediately after, and at 1, 3, and 6 months post-injection. Evaluation methods included standardized photography, independent physician scoring of wrinkle severity, and measurement of wrinkle volume, depth, and surface area using the VisioFace device. Additionally, ultrasonographic parameters and skin elasticity (R0, R2, R5) were recorded at baseline and follow-up visits. Patient satisfaction and adverse events were also documented during follow-up.
At months 1, 3, and 6, 62.9%, 82.7%, and 73% of participants respectively demonstrated at least a one-grade improvement in wrinkle severity. Also, results showed a statistically significant reduction in nasolabial fold severity at all post-treatment visits (p < 0.01). Significant decreases in wrinkle volume and surface area were observed bilaterally. Skin elasticity (R0) improved significantly at months 3 and 6. The median pain score during injection was low (2/10), with a maximum reported pain of 5/10. Four mild adverse events (swelling, bruising, gel accumulation) were reported in three participants, consistent with expected side effects of similar products. Patient satisfaction scores remained high throughout follow-up, ranging from 7 to 10 out of 10.
- Conditions
- Nasolabial Fold Correction
- Being tested
- Hyaluronic acid combined with calcium hydroxyapatite injection
- Keywords
- nasolabial fold, hyaluronic acid, calcium hydroxyapatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid combined with calcium hydroxyapatite injectionDevice
The filler was injected in nasolabial folds in a before-after setting
| Study group | Role | What they receive |
|---|---|---|
| Intella (hyaluronic acid combined with calcium hydroxyapatite, produced by Espad Pharmed Co.) | Experimental | The injection volume is 1-2 milliliters, determined based on the patient's needs and the injecting physician's discretion. The injection method may be linear or consist of multiple point injections using a 27-gauge needle or a 25-gauge cannula, depending on the physician's preference. During injection, the site and technique are carefully monitored to ensure that the filler is not injected into a blood vessel. If higher volumes are needed, multiple layers may be injected, with each layer positioned perpendicularly over the previous one (cross-hatching technique). After the injection, the area is gently massaged to ensure the volume is harmonized with the surrounding tissue. Immediately after injection, an ice pack is applied to the site for 15 minutes. Two weeks after the initial injection, if corrective injection is needed, an additional session with a maximum of 1 milliliter of filler may be performed. Receives: Device: Hyaluronic acid combined with calcium hydroxyapatite injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of individuals with at least a one-grade reduction in the severity of both nasolabial folds compared to baseline based on the Allergan scale
The scale is from 0 to 4, 0 indicating no wrinkle, and 4 indicating very deep wrinkle, redundant fold (overlapping skin)
Measured: Baseline, Week 4
Secondary outcomes (13)
The number of individuals with at least a one-grade reduction in the severity of both nasolabial folds compared to baseline based on the Allergan scale
The scale is from 0 to 4, 0 indicating no wrinkle, and 4 indicating very deep wrinkle, redundant fold (overlapping skin)
Measured: Baseline, Week 12, Week 24
Assessment of changes in depth of the right and left nasolabial folds
Measured: Baseline, Week 4, Week 12, Week 24
Assessment of changes in surface area of the right and left nasolabial folds
Measured: Baseline, Week 4, Week 12, Week 24
Assessment of changes in volume of the right and left nasolabial folds
Measured: Baseline, Week 4, Week 12, Week 24
Assessment of changes in dermal thickness in the right nasolabial fold area compared to baseline
Measured: Baseline, Week 4, Week 24
Assessment of changes in density in the right nasolabial fold area compared to baseline
Measured: Baseline, Week 4, Week 24
Assessment of changes in skin elasticity parameter (R0) in the middle of the right nasolabial fold compared to baseline.
Measured: Baseline, Week 12, Week 24
Assessment of changes in skin elasticity parameter (R2) in the middle of the right nasolabial fold compared to baseline.
Measured: Baseline, Week 12, Week 24
Assessment of changes in skin elasticity parameter (R5) in the middle of the right nasolabial fold compared to baseline.
Measured: Baseline, Week 12, Week 24
Assessment of changes in nasolabial fold severity compared to baseline by GAIS score, using before and after photographs
The scale is from 1 to 5, 1 indicating exceptional improvement i.e., excellent corrective result, and 5 indicating worsened patient i.e., the appearance has worsened compared with the original condition
Measured: Baseline, Week 4, Week 12, Week 24
Consumer satisfaction measured using the Visual Analogue Scale (VAS) (from 0 to 10, where 10 indicates complete satisfaction and 0 indicates complete dissatisfaction)
Measured: Day 1, Week 2, Week 4, Week 12, Week 24
Pain intensity assessment using the VAS from 0 to 10
Visual Analogue Scale (VAS): pain intensity scale where 0 indicates no pain and 10 indicates the maximum pain imaginable.
Measured: Day 1, Week 2 (based on physician's assessment regarding the need for a touch-up injection)
Safety assessment by evaluation of adverse events (AEs)
Adverse events (AEs) were assessed at all visits. The severity, seriousness, and causality of each AE were evaluated. The seriousness of AEs was determined according to International Council for Harmonization (ICH-E2B) guidelines, causality was assessed based on World Health Organization (WHO) criteria, and severity was classified as mild, moderate, or severe.
Measured: Day 1, Week 2, Week 4, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start2 Jan 2024
- Primary completion14 Feb 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Fold CorrectionStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Espad Pharmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102537
- Sponsor's protocol ID
- INT.ESP.AF.IV.02
- Status last verified
- Jun 2025
- First submitted
- 13 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data produced in the present study are available upon reasonable request from the investigators.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 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 Intella Dermal Filler (Produced by Espad Pharmed Darou Co.) for Correction of Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT07102537
- Acronym / sponsor ID
- INT.ESP.AF.IV.02
- Conditions
- Nasolabial Fold Correction
- Keywords
- nasolabial fold, hyaluronic acid, calcium hydroxyapatite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Espad PharmedIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 3 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.
This single-arm, before-and-after clinical trial evaluated the safety and efficacy of Intella, a combined CaHA and HA dermal filler manufactured by Espad Pharmed Darou Co., for the correction of moderate to severe nasolabial folds. The study involved 30 female participants with a mean age of 48.8 years (range 34-64 years).
After obtaining written informed consent and confirming eligibility criteria, 1 to 2 ml of Intela filler was injected subcutaneously into the bilateral nasolabial fold areas by a dermatologist. Assessments were performed immediately before, immediately after, and at 1, 3, and 6 months post-injection. Evaluation methods included standardized photography, independent physician scoring of wrinkle severity, and measurement of wrinkle volume, depth, and surface area using the VisioFace device. Additionally, ultrasonographic parameters and skin elasticity (R0, R2, R5) were recorded at baseline and follow-up visits. Patient satisfaction and adverse events were also documented during follow-up.
At months 1, 3, and 6, 62.9%, 82.7%, and 73% of participants respectively demonstrated at least a one-grade improvement in wrinkle severity. Also, results showed a statistically significant reduction in nasolabial fold severity at all post-treatment visits (p < 0.01). Significant decreases in wrinkle volume and surface area were observed bilaterally. Skin elasticity (R0) improved significantly at months 3 and 6. The median pain score during injection was low (2/10), with a maximum reported pain of 5/10. Four mild adverse events (swelling, bruising, gel accumulation) were reported in three participants, consistent with expected side effects of similar products. Patient satisfaction scores remained high throughout follow-up, ranging from 7 to 10 out of 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intella (hyaluronic acid combined with calcium hydroxyapatite, produced by Espad Pharmed Co.) | Experimental | Device: Hyaluronic acid combined with calcium hydroxyapatite injectionThe injection volume is 1-2 milliliters, determined based on the patient's needs and the injecting physician's discretion. The injection method may be linear or consist of multiple point injections using a 27-gauge needle or a 25-gauge cannula, depending on the physician's preference. During injection, the site and technique are carefully monitored to ensure that the filler is not injected into a blood vessel. If higher volumes are needed, multiple layers may be injected, with each layer positioned perpendicularly over the previous one (cross-hatching technique). After the injection, the area is gently massaged to ensure the volume is harmonized with the surrounding tissue. Immediately after injection, an ice pack is applied to the site for 15 minutes. Two weeks after the initial injection, if corrective injection is needed, an additional session with a maximum of 1 milliliter of filler may be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must have moderate to severe nasolabial folds based on the Allergan scale.
- Participants must be able to comply with the visit schedule and study procedures.
- Participants must have signed the informed consent form and agreed to the 6-month follow-up
Key exclusion criteria (14 listed)
- History of type 1 hypersensitivity reactions or anaphylaxis.
- Previous allergy or sensitivity to filler components or lidocaine.
- History of hypertrophic or keloid scar formation or bleeding disorders in the nasolabial area.
- Presence of active inflammatory processes, infection, or lesions (malignant/non-malignant) in the nasolabial area.
- History of autoimmune diseases/immunodeficiency or use of immunosuppressive drugs within 6 months prior to or during the study.
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 |
|---|---|---|
| Hyaluronic acid combined with calcium hydroxyapatite injectionThe filler was injected in nasolabial folds in a before-after setting | Device | Intella (hyaluronic acid combined with calcium hydroxyapatite, produced by Espad Pharmed Co.) |
Primary outcome
The number of individuals with at least a one-grade reduction in the severity of both nasolabial folds compared to baseline based on the Allergan scale
Time frame: Baseline, Week 4
The scale is from 0 to 4, 0 indicating no wrinkle, and 4 indicating very deep wrinkle, redundant fold (overlapping skin)
13 secondary outcomes
The number of individuals with at least a one-grade reduction in the severity of both nasolabial folds compared to baseline based on the Allergan scale
Time frame: Baseline, Week 12, Week 24
Assessment of changes in depth of the right and left nasolabial folds
Time frame: Baseline, Week 4, Week 12, Week 24
Assessment of changes in surface area of the right and left nasolabial folds
Time frame: Baseline, Week 4, Week 12, Week 24
Assessment of changes in volume of the right and left nasolabial folds
Time frame: Baseline, Week 4, Week 12, Week 24
Assessment of changes in dermal thickness in the right nasolabial fold area compared to baseline
Time frame: Baseline, Week 4, Week 24
Assessment of changes in density in the right nasolabial fold area compared to baseline
Time frame: Baseline, Week 4, Week 24
Assessment of changes in skin elasticity parameter (R0) in the middle of the right nasolabial fold compared to baseline.
Time frame: Baseline, Week 12, Week 24
Assessment of changes in skin elasticity parameter (R2) in the middle of the right nasolabial fold compared to baseline.
Time frame: Baseline, Week 12, Week 24
Assessment of changes in skin elasticity parameter (R5) in the middle of the right nasolabial fold compared to baseline.
Time frame: Baseline, Week 12, Week 24
Assessment of changes in nasolabial fold severity compared to baseline by GAIS score, using before and after photographs
Time frame: Baseline, Week 4, Week 12, Week 24
Consumer satisfaction measured using the Visual Analogue Scale (VAS) (from 0 to 10, where 10 indicates complete satisfaction and 0 indicates complete dissatisfaction)
Time frame: Day 1, Week 2, Week 4, Week 12, Week 24
Pain intensity assessment using the VAS from 0 to 10
Time frame: Day 1, Week 2 (based on physician's assessment regarding the need for a touch-up injection)
Safety assessment by evaluation of adverse events (AEs)
Time frame: Day 1, Week 2, Week 4, Week 12, Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No. Data produced in the present study are available upon reasonable request from the investigators.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid combined with calcium hydroxyapatite injection in people with Nasolabial Fold Correction, run by Espad Pharmed at 1 site 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 3 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: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of individuals with at least a one-grade reduction in the severity of both nasolabial folds compared to baseline based on the Allergan scale (time frame: Baseline, Week 4). 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 3 Aug 2025.