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

NCT ID: NCT07102537

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2025-02-28

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intella (hyaluronic acid combined with calcium hydroxyapatite, produced by Espad Pharmed Co.)

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.

Group Type: EXPERIMENTAL

Hyaluronic acid combined with calcium hydroxyapatite injection

Intervention Type: DEVICE

The filler was injected in nasolabial folds in a before-after setting

Interventions

Hyaluronic acid combined with calcium hydroxyapatite injection

The filler was injected in nasolabial folds in a before-after setting

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 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:

1. Botulinum toxin type A injections below the zygomatic arch within 6 months prior to study entry.

2. Non-permanent dermal filler injections (e.g., bovine collagen, hyaluronic acid) in facial areas within 1 year prior to study entry.

3. 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.

4. Deep skin peeling procedures such as chemical peeling, laser, dermabrasion, radio frequency within 6 months prior to study entry.

5. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Espad Pharmed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orchid Pharmed, Medical Department

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

INT.ESP.AF.IV.02

Identifier Type: -

Identifier Source: org_study_id