Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus
NCT ID: NCT02179606
Last Updated: 2014-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dermalax Implant Plus
Subject injected in the nasolabial folds of one side of the face in the initial treatment period.
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.
Restylane Sub-Q
Subject injected in the nasolabial folds of one side of the face in the initial treatment period.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Subjects who have a history of bleeding disorder.
3. Subjects who have received calcium hydroxyapatite, CaHA injection in nasolabial area.
30 Years
75 Years
ALL
Yes
Sponsors
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Across Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Beom Joon Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Jong Hoon Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Eulji General Hospital
Locations
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Chung-ang University Hospital
Seoul, , South Korea
Eulji General Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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AC-13-01
Identifier Type: -
Identifier Source: org_study_id
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