Orchid Pharmed, Medical Department
Tehran, Tehran Province, 19947-66411, Iran
NCT Number: NCT07102537
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Tehran, Tehran Province, 19947-66411, Iran
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The filler was injected in nasolabial folds in a before-after setting
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)
Time frame: Baseline, Week 12, Week 24
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, Week 12, Week 24
Time frame: Baseline, Week 4, Week 12, Week 24
Time frame: Baseline, Week 4, Week 12, Week 24
Time frame: Baseline, Week 4, Week 24
Time frame: Baseline, Week 4, Week 24
Time frame: Baseline, Week 12, Week 24
Time frame: Baseline, Week 12, Week 24
Time frame: Baseline, Week 12, Week 24
Time frame: Baseline, Week 4, Week 12, Week 24
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: Day 1, Week 2, Week 4, Week 12, Week 24
Time frame: Day 1, Week 2 (based on physician's assessment regarding the need for a touch-up injection)
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, Week 4, Week 12, Week 24
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.
Espad Pharmed
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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