Comparative study on the safety and efficacy of Hyfil and Restylane for correction of nasolabial folds

Phase 4

Completed

• Conditions: Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecifiedHealth Condition 2: null- Nasolabial fold correction

• Registration Number: CTRI/2010/091/006096
• Lead Sponsor: Virchow Biotech Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-06-05
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

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

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

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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