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A Study of YVOIRE Y-Solution 360 for Hand Augmentation to Correct Volume Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112017
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
LG Chem

Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of YVOIRE Y-Solution 360 in the treatment of dorsal hand to correct volume loss.

Condition or disease Intervention/treatment Phase
Dorsal Hand Volume Loss Device: YVOIRE Y-Solution 360 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, No-treatment Controlled, Parallel, Evaluator-blind, Medical Device Pivotal Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 360 Injected Into Dorsal Hand for Hand Augmentation to Correct Volume Loss
Actual Study Start Date : September 27, 2019
Estimated Primary Completion Date : July 27, 2020
Estimated Study Completion Date : July 27, 2021

Arm Intervention/treatment
Experimental: YVOIRE Y-Solution 360
Maximum 5 ml including touch-up
Device: YVOIRE Y-Solution 360
Hyaluronic acid

No Intervention: No-treatment
No-treatment. At 12 weeks after the assessment, treatment maximum 5 ml including touch-up



Primary Outcome Measures :
  1. ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded [ Time Frame: 12 weeks after treatment ]
    5-grade photonumeric hand grading scale (grade 0 - grade 4)


Secondary Outcome Measures :
  1. ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator [ Time Frame: Up to 52 weeks after treatment ]
    5-grade photonumeric hand grading scale (grade 0 - grade 4)

  2. ≥ 1 grade improvement on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject [ Time Frame: Up to 52 weeks after treatment ]
    5-point scale rating global aesthetic improvement in appearance (score -1 - score 3)

  3. Change from baseline on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator [ Time Frame: Up to 52 weeks after treatment ]
    5-grade photonumeric hand grading scale (grade 0 - grade 4)

  4. Change from baseline on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject [ Time Frame: Up to 52 weeks after treatment ]
    5-point scale rating global aesthetic improvement in appearance (score -1 - score 3)

  5. Safety profile as assessed by incidence of adverse events [ Time Frame: Up to 52 weeks after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 19 Years and older
  2. Hand Volume Rating Scale (HVRS) of grade 2 or 3 with both hands
  3. Participants who are willing to undergo the treatment of dorsal hand to correct volume loss

Exclusion Criteria:

  1. Congenital defect, external injuries, lipodystrophy, unhealed wound, disease related-abnormalities, or tumors on the dorsal hands
  2. Active inflammation or infection on the dorsal hands
  3. Received anti-coagulation therapy, anti-platelet therapy, or expected to require repeated treatment within 2 weeks prior to visit 2 (randomization)
  4. Had locally applied ointments (steroid, retinoid, anti-wrinkle production, tanning, or any other form of irritating product) or expected to require repeated treatment within 4 weeks prior to visit 2 (randomization)
  5. Received immuno-suppressive medication including systemic glucocorticoids or expected to require repeated treatment within 8 weeks prior to visit 2 (randomization)
  6. Received NSAIDs, Vitamin E, or expected to require repeated treatment within 1 week prior to visit 2 (randomization)
  7. Had dermal filler injections (HA, CaHA, silicon, PAAG, PMMA etc.), Botulinum toxin therapy, adipose tissue transplantation, or esthetic surgery within 12 months prior to visit 2 (randomization)

Information from the National Library of Medicine

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): NCT04112017


Contacts
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Contact: So Dam Yang 82-2-6987-4148 sodam@lgchem.com
Contact: Hyunjoo Lee 82-2-6987-4285 hjlee7@lgchem.com

Locations
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Korea, Republic of
Soonchunhyang University Recruiting
Bucheon, Gyeonggi-do, Korea, Republic of
Contact: Eun Soo Park         
Eulji Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jong Hun Lee         
Sponsors and Collaborators
LG Chem

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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT04112017    
Other Study ID Numbers: LG-HACL019
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LG Chem:
Hyalunic acid
Filler
Dorsal hand
Medical device
Additional relevant MeSH terms:
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Pharmaceutical Solutions