The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction

NCT ID: NCT02128204

Last Updated: 2015-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-01-31

Brief Summary

The study is a double-blind, randomized, within-subject controlled, 2-armed, single-centre study sponsored by SciVision Biotech Inc. and approved by Yuan's General Hospital Institutional Review Board. The aim of this post-marketing study is to evaluate the safety and efficacy of HYADERMIS LA facial dermal implant for the improvement of nasolabial folds.

The study was estimated to be held half to one year including a 0-2 weeks screening period, a day of treatment, and follow-up at week 1 and 2. Patient informed consent forms will be obtained before volunteers enter screening period. If the volunteers meet all the criteria, they will be given a number to replace their name in the study. The participants will be randomised assigned to receive experiment treatment, HYADERMIS LA, in one side of nasolabial folds and control treatment, Hya-Dermis, in the other side of the face. The safety assessment evaluated any recorded adverse events following the device treatments either by blinded evaluator or subjects. The effectiveness of the treatment devices will be assessed by using photographic assessment, nasoalabial folds severity scale, global aesthetic improvement scale, and pain visual analog scale.

Conditions

Pain; Nosalabial Folds Correction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

HYADERMIS LA Facial Dermal Implant

Subjects will be randomly assigned to receive experiment treatment, lidocaine contained hyaluronate facial dermal filler, in one side of the face.

Group Type: EXPERIMENTAL

lidocaine contained hyaluronate facial dermal filler

Intervention Type: DEVICE

HYADERMIS LA Facial Dermal Implant contains 20 mg/ml hyaluronate and 0.3 % lidocaine.

Hya-Dermis Facial Dermal Implant

Subjects will be randomly assigned to receive control treatment, hyaluronate facial dermal filler, in one side of the face.

Group Type: ACTIVE_COMPARATOR

hyaluronate facial dermal filler

Intervention Type: DEVICE

Hya-Dermis Facial Dermal Implant contains 20 mg/ml hyaluronate.

Interventions

lidocaine contained hyaluronate facial dermal filler

HYADERMIS LA Facial Dermal Implant contains 20 mg/ml hyaluronate and 0.3 % lidocaine.

Intervention Type: DEVICE

hyaluronate facial dermal filler

Hya-Dermis Facial Dermal Implant contains 20 mg/ml hyaluronate.

Intervention Type: DEVICE

Other Intervention Names

HYADERMIS LA Facial Dermal Implant; Hya-Dermis Facial Dermal Implant

Eligibility Criteria

Inclusion Criteria

• Be 25 to 60 years of age and of any sex who is willing to receive nasolabial folds correction by intradermal injection procedures
• Have approximately symmetrical nasolabial folds with a nasolabial folds severity grade of 2-4 and the grade difference between two sides is less than 1
• Agree to refrain from undergoing invasive aesthetic treatments in the injective areas 12 months after the injections
• Agree to refrain from undergoing other physical or chemical aesthetic treatments in the injective areas 3 months after the injections
• If female of child-bearing potential, not be breastfeeding, have a negative urine pregnancy test on the treatment day and agree to use any approved contraceptives or medically acceptable method of birth control throughout the study
• Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures

Exclusion Criteria

• Have history or active dermal diseases, inflammation, or any related disease
• Had permanent or semi-permanent implantation on nasolabial areas
• Had invasive aesthetic treatments or surgeries history 6 months before the treatments
• Had physical or chemical aesthetic treatments 1 months before the study starts
• Have history of coagulation defect diseases and still take aspirin, anticlotting, or blood activating medications 1 week before the treatments
• Have Adams-Stokes syndromes, wolff-prkinson-white syndromes, severe sinus node, the atrioventricular node dysfunction, or the blocked ventricular
• Have a known history of allergic reactions like hypersensitivity to hyaluronic acid
• Have a known history of allergic reactions like hypersensitivity to lidocaine or other anaesthetics
• Have poor compliance with the study or follow-up schedule

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SciVision Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chao-Hong Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Yuan's General Hospital

Locations

Aesthetic Center of Yuan's General Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

RDCT-YDL

Identifier Type: -

Identifier Source: org_study_id