An interventional study of Hyaluronic acid combined with calcium hydroxyapatite injection in Nasolabial Fold Correction, sponsored by Espad Pharmed. Completed at 1 site in Iran. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Espad Pharmed · Not applicable, Interventional, and Treatment
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.
Espad Pharmed is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use of cosmetic treatments in recent months or plans to undergo such treatments in the near future during the study, including:
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.
Device: Hyaluronic acid combined with calcium hydroxyapatite injection
The filler was injected in nasolabial folds in a before-after setting
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)
Time frame: Baseline, Week 4
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)
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
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
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
Visual Analogue Scale (VAS): pain intensity scale where 0 indicates no pain and 10 indicates the maximum pain imaginable.
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)
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.
Time frame: Day 1, Week 2, Week 4, Week 12, Week 24
Plan to share: No — Data produced in the present study are available upon reasonable request from the investigators.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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