HArmonyCa Injectable Gel for Mid Face Soft Tissue Augmentation

NCT05119777 | Completed Phase 4

• 2 other identifiers: M21-7872021-A01899-32
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

Prospective, open label, post marketing study of the safety and effectiveness of HArmonyCa injectable gel for mid-face soft tissue augmentation

Conditions

Soft Tissue Augmentation

Outcome Measures

Primary Outcomes (1)

• Responder status of achieving ≥ 1-grade improvement from baseline on Mid Face Volume Deficit Scale (MFVDS) based on EI's (Evaluating Investigator) live assessment at Month 1

  The MFVDS is a validated, 6-point scale with grades of severe (5), significant (4), moderate (3), mild (2), minimal (1), and none (0)

  1 Month

Secondary Outcomes (3)

• Responder status of achieving improved or much improved on Global Aesthetic Improvement Scale (GAIS) based on EI live assessment at Month 1 visit

  1 Month

• Responder status of achieving improved or much improved on GAIS based on participant assessment at Month 1 visit

  1 Month

• Change from baseline on FACE-Q Satisfaction with Cheeks specific questionnaire at Month 1 visit

  1 Month

Study Arms (1)

HArmonyCa Injectable Gel

EXPERIMENTAL

HArmonyCa injected at the discretion of the Treating Investigator (TI) to the midface for initial treatment and an optional touch-up treatment 14 days later

Device: HArmonyCa Injectable Gel

Interventions

HArmonyCa Injectable Gel DEVICE

Subdermal or deep dermal injection

HArmonyCa 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 18 or older at the time of signing the ICF
• In general good health
• Participant seeking soft tissue augmentation in the mid face
• Has moderate or severe mid face volume deficit (Grade 5, 4, or 3 on the MFVDS) for each cheek on EI (Evaluating Investigator) live assessment (both cheeks must qualify but do not need to have the same score)
• Each cheek is amenable to achieving at least a 1-point improvement on the MFVDS with study intervention in the judgment of the EI (Evaluating Investigator)/TI (Treating Investigator)
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
• Written informed consent from the participant has been obtained prior to any study-related procedures
• Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
• Able, as assessed by the EI, and willing to follow study instructions (including compliance with the safety diary) and likely to complete all required study visits
• Fluent and literate in French

You may not qualify if:

• HArmonyCa is contraindicated:
• in patients with a known sensitivity to any of the product components.
• in patients suffering from skin disease or abnormal skin conditions.
• in patients suffering from an infection or inflammation (either acute or chronic) at or near the treatment site.
• in patients susceptible to keloid formation, hypertrophic scarring, or developing inflammatory skin conditions.
• in patients with impaired wound healing due to systemic disorders, medicinal drugs, or unhealthy or poorly-vascularized tissue.
• in patients suffering from prolonged bleeding or tissue healing due to medical conditions or medicinal drugs.
• in patients with a history of anaphylactic reactions and/or multiple severe allergies.
• in patients with a known sensitivity to steroids, or who are contraindicated to be treated with steroids.
• for injection into the glabellar or periocular areas.
• for injection into the lips and perioral region.
• for injection into regions containing foreign bodies.
• in patients presenting with herpes.
• in patients with autoimmune diseases.
• for injection into blood vessels and to highly vascularized areas.

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Eurofins Dermscan Pharmascan /ID# 240921

Aix-en-Provence, 13594, France

Location

Eurofins Pharmascan /ID# 240920

Lyon, 69100, France

Location

Related Links

• clinical study report synopsis

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 15, 2021
• Study Start: October 13, 2021
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

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: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

FR (2)