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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •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).
结局指标
主要结局
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
时间窗: Baseline, Week 4
The scale is from 0 to 4, 0 indicating no wrinkle, and 4 indicating very deep wrinkle, redundant fold (overlapping skin)
次要结局
- 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(Baseline, Week 12, Week 24)
- Assessment of changes in depth of the right and left nasolabial folds(Baseline, Week 4, Week 12, Week 24)
- Assessment of changes in surface area of the right and left nasolabial folds(Baseline, Week 4, Week 12, Week 24)
- Assessment of changes in volume of the right and left nasolabial folds(Baseline, Week 4, Week 12, Week 24)
- Assessment of changes in dermal thickness in the right nasolabial fold area compared to baseline(Baseline, Week 4, Week 24)
- Assessment of changes in density in the right nasolabial fold area compared to baseline(Baseline, Week 4, Week 24)
- Assessment of changes in skin elasticity parameter (R0) in the middle of the right nasolabial fold compared to baseline.(Baseline, Week 12, Week 24)
- Assessment of changes in skin elasticity parameter (R5) in the middle of the right nasolabial fold compared to baseline.(Baseline, Week 12, Week 24)
- Assessment of changes in skin elasticity parameter (R2) in the middle of the right nasolabial fold compared to baseline.(Baseline, Week 12, Week 24)
- Assessment of changes in nasolabial fold severity compared to baseline by GAIS score, using before and after photographs(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)(Day 1, Week 2, Week 4, Week 12, Week 24)
- Pain intensity assessment using the VAS from 0 to 10(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)(Day 1, Week 2, Week 4, Week 12, Week 24)