A Study to Evaluate the Safety and Efficacy of SYB Filler(SF-01) in the Correction of Nasolabial Folds

NCT03932045 | Completed

• 1 other identifier: SYB-SF01-301
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to verify the safety and efficacy of SYB Filler (SF-01) in the temporary improvement of Nasolabial Folds.

Conditions

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to 12months in Wrinkle Severity Rating Scale (WSRS) Score by independent evaluator assessed

  The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.

  12months

Study Arms (2)

SYB Filler (SF-01)

EXPERIMENTAL

PCL filler

Device: SYB Filler (SF-01)

Ellansé M

ACTIVE COMPARATOR

PCL filler

Device: Ellansé M

Interventions

SYB Filler (SF-01) DEVICE

Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold.

SYB Filler (SF-01)

Ellansé M DEVICE

Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold.

Ellansé M

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS)
• Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study.

You may not qualify if:

• Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening
• Administered Vitamin E or non-steroidal anti-inflammatory drugs or Collagen within 1 week of the date of the screening, or who require these during the period of the study
• History of bleeding disorder in past or present
• Received deep-peeling, skin regeneration, plastic surgery (including botulinum toxin injection), wrinkle improvement or acne scar treatment in the facial area within 24 weeks of the date of the screening
• Administered an hyaluronic acid filler within 24 weeks of the date of the screening

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, South Korea

Location

Study Officials

• Beom Joon KIM, M.D.,Ph.D.

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Subject \& Evaluator-blind, Matched pairs, Prospective Study

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: April 30, 2019
• Study Start: October 8, 2018
• Primary Completion: September 15, 2020
• Study Completion: August 12, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

KR (1)