Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified Health Condition 2: null- Nasolabial fold correction
Conditions
Interventions
Intervention1: Hyfil Regular: 1 ml
Control Intervention1: Restylane: 1 ml
Sponsors
Virchow Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of both genders completed 18 years of age; 2. Subjects with moderate to severe bilateral nasolabial folds with wrinkle severity rating scale scores of 3 or 4; 3. Subjects willing to abstain from other cosmetic procedures (further augmentation therapy, laser or chemical skin resurfacing, botulinun toxin injections, or facelift procedures) during the study period; 4. Subjects who are willing to sign the informed consent and will be available for all follow-up visits. 5. Not on any painkillers/anti-inflammatory/antioxidant drugs, aspirin and other anticoagulant drugs 10 days prior to the screening; 6.No history of keloid tendency; 7.In case of female volunteers, negative pregnancy test during screening.
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women; 2.Subjects who had previously received facial soft tissue augmentation with hyaluronic acid or other types of fillers, or cosmetic facial surgery/implants, botulinum toxin injections, or face lift procedures within the previous 6 months from screening date. 3.Subjects who had received laser treatment and chemical peeling in the past 3 months from screening date; 4.Subjects with history of allergic reaction to the study product. 5.Any medical history of systemic diseases (liver or renal functional abnormalities, uncontrolled metabolic diseases, neurological diseases) or serious medical illness; 6.Alcohol or drug or medication abuse; 7.Protocol non-compliant subjects; 8.Any significant laboratory findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in wrinkle severity rating scale (WSRS) from baseline to 2, 8, 16, 24 weeks during post therapy ? assessment by investigator.Timepoint: weeks 2, 8, 16 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in global aesthetic improvement scale (GAIS) from baseline to 2, 8, 16, 24 weeks during post therapy - assessment by both investigator and patient;Timepoint: weeks 2, 8, 16 and 24;Incidence of adverse events and local injection site reactionsTimepoint: Week 2, 8, 16 and 24 | — |
Countries
India
Contacts
Public ContactDr TC Raghuram
Medical Director
Outcome results
None listed