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NCT Number: NCT07032597

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mid Face Volume Deficit

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Hospital /ID# 272476, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HArmonyCa Lidocaine Injectable Gel

Device

Subdermal or Deep Dermal or Supraperiosteal Injection

Restylane® Perlane® Lidocaine

Device

Subcutaneous to Supraperiosteal Implantation Injection

Primary outcomes

  1. Percentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS)

    Time frame: Month 6

    A "responder" is a participant with at least 1-point improvement (reduction) of mid face volume deficit using the MFVDS. MFVDS is a validated 5-point scale (1 = None/Minimal to 5 = Severe).

  2. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Approximately Month 14

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a medical device which does not necessarily have a causal relationship with this treatment.

Secondary outcomes

  1. Percentage of Participants Achieving "Responder" Status Based on EI's Assessments of Global Aesthetic Improvement in the Treatment Area Using the Global Aesthetic Improvement Scale (GAIS)

    Time frame: Month 6

    A "responder" is a participant who achieves "Improved" or "Much Improved" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the treatment area (2 = Much Improved, -2 = Much Worse).

  2. Percentage of Participants Achieving "Responder" Status Based on Participant's Assessments of Global Aesthetic Improvement in the Treatment Area Using GAIS

    Time frame: Month 6

    A "responder" is a participant who achieves "Improved" or "Much Improved" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the treatment area (2 = Much Improved to -2 = Much Worse).

  3. Change from Baseline on the Overall Score of FACE-Q Satisfaction with Cheeks

    Time frame: Month 6

    The FACE-Q Satisfaction with Cheeks questionnaire is a 5-point survey where 1 = Very Dissatisfied and 4 = Very Satisfied.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Multicenter, Evaluator Blinded, Randomized Study to Evaluate the Safety and Effectiveness of HArmonyCa Lidocaine Compared to Restylane® Perlane® Lidocaine for Restoration and/or Creation of Mid-face Volume

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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