NCT07102537

Evaluation of Efficacy and Safety of Intella Dermal Filler in Moderate to Severe Nasolabial Folds

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Espad Pharmed · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
DEVICE	Hyaluronic acid combined with calcium hydroxyapatite injection	The filler was injected in nasolabial folds in a before-after setting

Timeline

• Start date: 2024-01-02
• Primary completion: 2024-02-14
• Completion: 2025-02-28
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

1 site across 1 country: Iran