Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus

Correction of Nasolabial Folds Clinical Trial

Official title:

A Multi-Center, Randomized, Subject and Evaluator Blind, Split-Face Comparative Medical Device Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus to Restylane® Sub-Q for Correction of Nasolabial Folds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179606
• Other study ID #: AC-13-01
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2014
• Last updated: July 4, 2014
• Start date: July 2013

Study information

• Verified date: March 2014
• Source: Across Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

This study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects no younger than 30 and no more than 75 years of age.

2. Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.*)

*The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-4.

3. Subjects who have symmetric nasolabial folds.

Exclusion Criteria:

1. Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin less than 300 mg/day)

2. Subjects who have a history of bleeding disorder.

3. Subjects who have received calcium hydroxyapatite, CaHA injection in nasolabial area.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Correction of Nasolabial Folds

Intervention

Device:
• Dermalax Implant Plus
Dermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.
• Restylane Sub-Q
Restylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.

Locations

Country	Name	City	State
Korea, Republic of	Chung-ang University Hospital	Seoul
Korea, Republic of	Eulji General Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Across Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safty evaluation	adverse events, laboratory test, physical examination	for 24weeks	Yes
Primary	Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group	Improvement of wrinkle severity system scale(WSRS) scores at week 12 compared to baseline by independent evaluator using photos.	baseline, week 12	Yes
Secondary	Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group	Improvement of wrinkle severity system scale(WSRS) scores at week2, week8, week 16, week 24 compared to baseline by independent evaluator using photos.	baseline, at week 2~24	No
Secondary	Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved	Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved at week2, week 8, week 12, week 16, week 24 evaluated by investigator at site	at week 2~24	No
Secondary	100 mm visual analogue scale (VAS) scores evaluation	100 mm visual analogue scale (VAS) scores at both nasolabial folds evaluated by subjects at application of the devices	week 0	No