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A double-center, prospective, randomized controlled trial to evaluate the efficacy, safety, and satisfaction of different injection methods using ART FILLER UNIVERSAL for correcting moderate to severe nasolabial folds in Chinese adults

A double-center, prospective, randomized controlled trial to evaluate the efficacy, safety, and satisfaction of different injection methods using ART FILLER UNIVERSAL for correcting moderate to severe nasolabial folds in Chinese adults

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041702
Enrollment
Unknown
Registered
2021-01-01
Start date
2020-12-22
Completion date
Unknown
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasolabial fold

Interventions

A:The left side was injected with the traditional deep and shallow layer method, while the right side was injected with the ligament method
B:The right side was injected with the traditional deep and shallow layer method, while the left side was injected with the ligament method

Sponsors

Guangdong Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects older than or equal to 18 years old; 2. Patients who intend to correct bilateral nasolabial fold were evaluated as moderate to severe nasolabial fold (WSRs grade 2-3); 3. Subjects who voluntarily participated in the study and signed informed consent; 4. The subjects who can communicate well with the researchers and comply with the requirements of the whole trial can return to the hospital for reexamination on the follow-up date.

Exclusion criteria

Exclusion criteria: 1. Women who were pregnant or breast-feeding or planned to be pregnant during the study period; 2. Patients who have received facial cosmetic surgery; 3. Subjects with known allergies to any study drug or anesthetic used in the study; 4. Patients with anticoagulant therapy or antiplatelet therapy (such as non steroidal anti-inflammatory drugs, aspirin, vitamin E, etc.) or history of hemorrhagic disease within 2 weeks before treatment; 5. Patients with unhealed inflammation or other related diseases at the site to be treated, such as infection, psoriasis and herpes zoster; 6. Patients with obvious facial asymmetry (such as big and small eyes, etc.); 7. Subjects who plan to undergo any other facial plastic surgery or cosmetic operation (e.g., laser or chemical skin change, acupuncture, facial lifting, radiography, etc.) on the site to be treated throughout the study period; 8. Patients with local or systemic bacterial infection in acute stage that can not be effectively controlled.

Design outcomes

Primary

MeasureTime frame
Wrinkle Severity Rating Scale;Global Aesthetic Improvement Scale;

Countries

China

Contacts

Public ContactShengkang Luo

Guangdong Second People's Hospital

393900659@qq.com+86 13808825524

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026