The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction
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|ClinicalTrials.gov Identifier: NCT02128204|
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : January 21, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain Nosalabial Folds Correction||Device: lidocaine contained hyaluronate facial dermal filler Device: hyaluronate facial dermal filler||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Safety and Efficacy of Using HYADERMIS LA for Wrinkle Correction|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||January 2015|
Experimental: 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.
Device: lidocaine contained hyaluronate facial dermal filler
HYADERMIS LA Facial Dermal Implant contains 20 mg/ml hyaluronate and 0.3 % lidocaine.
Other Name: HYADERMIS LA Facial Dermal Implant
Active Comparator: Hya-Dermis Facial Dermal Implant
Subjects will be randomly assigned to receive control treatment, hyaluronate facial dermal filler, in one side of the face.
Device: hyaluronate facial dermal filler
Hya-Dermis Facial Dermal Implant contains 20 mg/ml hyaluronate.
Other Name: Hya-Dermis Facial Dermal Implant
- Adverse events report [ Time Frame: From the date of treatment to 14 days ]Any adverse events and abnormal physical parameters or reports occurred and disappeared should be monitored throughout the trial. The records should be assessed and keep on track of the severity of individual adverse events and correlation with the treatment. Severity assessment: To assess the level of severity by rating 0 (none), 1 (mild), 2 (median), and 3 (sever). Correlation assessment: Physicians evaluate the impact of adverse events for each individual and determine their causality of the treatment, giving score 0 (no correlated), 1 (low correlated), 2 (suspected correlated), 3 (most likely correlated ). Subjects will be given a medical diary after the treatment to record any adverse event and report to a physicians. Physicians keep following up adverse events until the symptoms stabilised.
- Pain Visual Analog Scale [ Time Frame: participants will be followed for the duration of treatment, an expected average of 10 minutes ]A quantification of the severity of pain experienced by the participants during the treatment. A scale of 100 mm horizontal line will be labeled by subjects to assess pain on both sides of the injected areas during the treatment. The one on the scale's extreme left (0) represents painless while the one on the extreme right (100) is set as the most pain could be imagined by subjects.
- Nasolabial folds severity scale [ Time Frame: From the baseline, 30 minutes post-treatment, and every follow-up at 1 and 2 weeks ]Based on Skin Aging Altas: Volume 2, Asian type photographs, taking gender and nasolabial folds into consideration to quantify the degree of nosalabial folds severity. A validated 8-point photographic scale scored the severity grade from 0 (absent) 7 (extreme) will be used to assess the severity.
- Global aesthetic improvement scale [ Time Frame: 30 minutes post-treatments and follow-ups at 1 and 2 weeks ]To quantify the level of overall aesthetic improvement and so giving a scale from 1 (worse), 2 (no change), 3 (improved), and 4 (much improved), and 5 (very much improved).
- Pain Visual Analog Scale [ Time Frame: 15, 30, 45, and 60 minutes post-treatment ]A quantification of the severity of pain experienced by the participants after the treatment. A scale of 100 mm horizontal line will be labeled by subjects to assess pain on both sides of the injected areas at 15, 30, 45, and 60 minutes post-treatment. The one on the scale's extreme left (0) represents painless while the one on the extreme right (100) is set as the most pain could be imagined by subjects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128204
|Aesthetic Center of Yuan's General Hospital|
|Kaohsiung City, Taiwan, 80249|
|Principal Investigator:||Chao-Hong Liu, M.D.||Department of Dermatology, Yuan's General Hospital|