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

NCT07032597 | Active Not Recruiting Phase 3

• 1 other identifier: M21-782
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Mid Face Volume Deficit

Keywords

Mid Face Volume Deficit; HArmonyCa Lidocaine; Restylane® Perlane® Lidocaine; Mid-Face China

Outcome Measures

Primary Outcomes (2)

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

  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).

  Month 6

• Number of Participants with Adverse Events (AEs)

  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.

  Up to Approximately Month 14

Secondary Outcomes (3)

• 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)

  Month 6

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

  Month 6

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

  Month 6

Study Arms (2)

HArmonyCa Lidocaine

EXPERIMENTAL

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

Device: HArmonyCa Lidocaine Injectable Gel

Restylane® Perlane® Lidocaine

ACTIVE COMPARATOR

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

Device: Restylane® Perlane® Lidocaine

Interventions

HArmonyCa Lidocaine Injectable Gel DEVICE

Subdermal or Deep Dermal or Supraperiosteal Injection

HArmonyCa Lidocaine

Restylane® Perlane® Lidocaine DEVICE

Subcutaneous to Supraperiosteal Implantation Injection

Restylane® Perlane® Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (9)

Beijing Hospital /ID# 272476

Beijing, Beijing Municipality, 100005, China

Location

Peking Union Medical College Hospital (West) - Xidan Campus /ID# 272480

Beijing, Beijing Municipality, 100032, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 272631

Wuhan, Hubei, 430022, China

Location

Nanjing Drum Tower Hospital /ID# 272468

Nanjing, Jiangsu, 210008, China

Location

Zhongda Hospital Southeast University /ID# 272471

Nanjing, Jiangsu, 210009, China

Location

Wuxi People'S Hospital /ID# 275928

Wuxi, Jiangsu, 214023, China

Location

Huashan Hospital Of Fudan University /ID# 272632

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Tongji Hospital /ID# 272509

Shanghai, Shanghai Municipality, 200065, China

Location

The First People's Hospital of Hangzhou /ID# 272475

Hangzhou, Zhejiang, 310006, China

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 24, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CN (9)