A Study to Assess Adverse Events and Change in Disease Activity of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft Tissue Augmentation in Adult Participants

NCT05452070 | Completed Phase 3

• 1 other identifier: M21-784
• Study Type: interventional
• Target: 171
• Locations: 3 countries
• Sites: 12

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 in adults seeking mid face soft tissue augmentation. 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 control group. Around 160 adult participants seeking soft tissue augmentation will be enrolled in the study at approximately 15 sites worldwide. Participants in the treatment group will receive HArmonyCa Lidocaine injectable gel at Day 1 and followed for up to 25 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HArmonyCa Lidocaine injectable gel during the follow-up duration period. Participants in the control group are followed for 3 months and then can opt to receive HArmonyCa Lidocaine Injectable Gel at the end of month 3. The control group will participate in the study for up to 25 months. 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 or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Conditions

Mid Face Volume Deficit

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) live assessment of Mid Face Volume Deficit Scale (MFVDS)

  A "responder" is a participant with at least 1- grade improvement (reduction) of mid face soft tissue deficit using the MFVDS. MFVDS is a validated 6-point scale (0 = None, 5 = Severe).

  Month 3

• Number of Participants with Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.

  Up to 25 Months

Secondary Outcomes (5)

• Percentage of Participants Achieving "Responder" Status for EI's Live Assessment of Global Aesthetic Improvement Scale (GAIS).

  Month 3

• Percentage of Participants Achieving "Responder" Status for Participant Assessment of Global Aesthetic Improvement Scale (GAIS).

  Month 3

• Change from baseline on overall score in FACE-Q Satisfaction with cheeks specific questionnaire

  Month 3

• Change from baseline on overall score in FACE-Q Satisfaction with lower face and jawline specific questionnaire

  Month 3

• Change from baseline on overall score in FACE-Q Satisfaction with appearance specific questionnaire

  Month 3

Study Arms (2)

HArmonyCa Lidocaine Injectable Gel

EXPERIMENTAL

Participants will receive HArmonyCa Lidocaine Injectable Gel on Day 1 and followed for up to 25 months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HArmonyCa Lidocaine injectable gel during the follow-up duration period.

Device: HArmonyCa Lidocaine Injectable Gel

Control Group

OTHER

Participants will be followed for 3 months. Participants can opt to receive HArmonyCa Lidocaine Injectable Gel after 3 months and followed for up to 25 months.

Device: HArmonyCa Lidocaine Injectable Gel

Interventions

HArmonyCa Lidocaine Injectable Gel DEVICE

Subdermal or deep dermal injection

Control Group; HArmonyCa Lidocaine Injectable Gel

Eligibility Criteria

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

You may qualify if:

• Participant must be in general good health.
• Participant seeking soft tissue augmentation in the mid face.
• Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
• Able, as assessed by the TI, and willing to follow study instructions (including compliance with the safety e-diary) and likely to complete all required study visits.

You may not qualify if:

• Has experienced trauma to the face within 6 months before enrollment or has residual deficiencies, deformities, or scarring
• Has active or recurrent inflammation or infection in either eye
• Has tendency to develop hypertrophic scarring and/or keloid scarring
• Has active autoimmune disease
• Has current cutaneous or mucosal inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion, in the face
• Has fat injection or permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face
• Has temporary dermal filler injections in the face within 24 months before enrollment
• Has semi-permanent fillers (eg, poly-L-lactic acid, CaHA) anywhere in the face within 36 months before enrollment
• Has botulinum toxin treatment in cheek area (including crow's feet) within 6 months before enrollment
• Has mesotherapy or cosmetic facial procedures in the face within 6 months before enrollment. Examples of mesotherapy or cosmetic facial procedures are face-lift, laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures
• Has tattoos, piercings, facial hair, (unless willing to remove prior to each assessment visit) or scars in the face that would interfere with the visualization of the face for the effectiveness assessment
• Undergone a dental procedure within 6 weeks before treatment or plan to undergo a dental procedure (other than prophylaxis or dental fillings) during the course of the study
• History of an allergic reaction or significant sensitivity to constituents of the study investigational product (and its excipients) and/or other products in the same class (lidocaine \[or any amide-based anesthetics\], HA products, or Streptococcal protein).
• Any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study.
• Any live vaccine within 4 weeks prior to the first dose of study treatment, or expected need of live vaccination during study participation including at least 4 weeks after the last dose of study treatment.

Sponsors & Collaborators

• Allergan: lead

Study Sites (12)

YVR Aesthetics Training & Study Centre /ID# 239809

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Humphrey & Beleznay Cosmetic Dermatology /ID# 239805

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Pacific Derm /ID# 240785

Vancouver, British Columbia, V6H 4E1, Canada

Location

Skin Matters Medical Aesthetic Centre /ID# 239986

Vancouver, British Columbia, V6M 4J2, Canada

Location

Dermetics Cosmetic Dermatology /ID# 246536

Burlington, Ontario, L7N 3N2, Canada

Location

The Centre for Clinical Trials /ID# 246409

Oakville, Ontario, L6J 7W5, Canada

Location

Bertucci MedSpa Inc. /ID# 246496

Woodbridge, Ontario, L4L 8E2, Canada

Location

Erevna Innovations Inc. /ID# 240401

Westmount, Quebec, H3C 1Z3, Canada

Location

Instituto Medico Miramar /ID# 240939

Málaga, Malaga, 29016, Spain

Location

WM Hospitals /ID# 245747

Barcelona, 08006, Spain

Location

Dr Nestor's Medical Cosmetic Centre /ID# 246406

Edinburgh, EH3 6RS, United Kingdom

Location

MediZen /ID# 240102

Sutton Coldfield, B74 2UG, United Kingdom

Location

Study Officials

• ALLERGAN INC.

  Allergan

  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: July 6, 2022
• First Posted: July 11, 2022
• Study Start: September 2, 2022
• Primary Completion: May 8, 2025
• Study Completion: May 8, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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

ES (2); GB (2); CA (8)