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

Not Applicable

Terminated

• Conditions: Dorsal Hand Volume Loss
• Interventions: Device: YVOIRE Y-Solution 360

• Registration Number: NCT04112017
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-27
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-29
• Study First Posted: 2019-10-02
• Primary Completion: 2020-10-14
• Study Completion: 2020-10-14
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 116

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YVOIRE Y-Solution 360	YVOIRE Y-Solution 360	Maximum 5 ml including touch-up

Primary Outcome Measures

Name	Time	Method
≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded	12 weeks after treatment	5-grade photonumeric hand grading scale (grade 0 - grade 4)

Secondary Outcome Measures

Name	Time	Method
≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator	Up to 52 weeks after treatment	5-grade photonumeric hand grading scale (grade 0 - grade 4)
≥ 1 grade improvement on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject	Up to 52 weeks after treatment	5-point scale rating global aesthetic improvement in appearance (score -1 - score 3)
Change from baseline on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator	Up to 52 weeks after treatment	5-grade photonumeric hand grading scale (grade 0 - grade 4)
Change from baseline on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject	Up to 52 weeks after treatment	5-point scale rating global aesthetic improvement in appearance (score -1 - score 3)
Safety profile as assessed by incidence of adverse events	Up to 52 weeks after treatment

Trial Locations

Locations (2)

Eulji Hospital; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang University; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of