A Study to Assess Safety and Effectiveness of HArmonyCa Lidocaine Injectable Gel for Restoration and/or Creation of Mid-Face Volume in Adult Participants

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-26

Study Completion Date

2026-10-31

Brief Summary

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The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The rapid restoration of soft tissue augmentation is commonly achieved by the use of dermal fillers. HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation. The purpose of this study is to assess adverse events and effectiveness of HArmonyCa Lidocaine injectable gel compared to Restylane® Perlane® Lidocaine (Perlane) in adults seeking restoration and/or correction of moderate to severe mid-face volume deficit.

HArmonyCa Lidocaine Injectable Gel is an investigational device being developed for soft tissue augmentation in the mid face. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the receive active comparator, Perlane. Around 252 adult participants seeking restoration and/or creation of mid-face volume will be enrolled in the study at approximately 9 sites in China.

Participants will receive HArmonyCa Lidocaine injectable gel or Perlane at Day 1 with an option touch-up treatment on Day 31. Participants will be followed for up to 12 Months after last treatment.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

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Detailed Description

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Conditions

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Mid Face Volume Deficit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HArmonyCa Lidocaine

Participants will receive HArmonyCa Lidocaine on Day 1 with optional touch-up treatment on Day 31.

Group Type EXPERIMENTAL

HArmonyCa Lidocaine Injectable Gel

Intervention Type DEVICE

Subdermal or Deep Dermal or Supraperiosteal Injection

Restylane® Perlane® Lidocaine

Participants will receive Perlane on Day 1 with optional touch-up treatment on Day 31.

Group Type ACTIVE_COMPARATOR

Restylane® Perlane® Lidocaine

Intervention Type DEVICE

Subcutaneous to Supraperiosteal Implantation Injection

Interventions

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HArmonyCa Lidocaine Injectable Gel

Subdermal or Deep Dermal or Supraperiosteal Injection

Intervention Type DEVICE

Restylane® Perlane® Lidocaine

Subcutaneous to Supraperiosteal Implantation Injection

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the Mid-face Volume Deficit Scale (MFVDS) 5-point photonumeric scale based on evaluating investigator (EI) live assessment at randomization visit.
* Mid-face areas are amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgment.
* Must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active pandemic infection.

Exclusion Criteria

* Excessive skin laxity in the mid-face area in the opinion of the TI.
* Significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area.
* Semi-permanent soft tissue filler treatment (e.g., CaHA, poly-L-lactic acid) in the face within 36 months before randomization.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No