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

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Mid Face Volume Deficit

Treatments: Device: HArmonyCa Lidocaine Injectable Gel; Device: Restylane® Perlane® Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07032597

M21-782

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 2 patient groups

HArmonyCa Lidocaine

Experimental group

Description:

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

Treatment:

Device: HArmonyCa Lidocaine Injectable Gel

Restylane® Perlane® Lidocaine

Active Comparator group

Description:

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

Treatment:

Device: Restylane® Perlane® Lidocaine