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HArmonyCa Injectable Gel for Mid Face Soft Tissue Augmentation | Clinical Trials | Clareo Health

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HArmonyCa Injectable Gel for Mid Face Soft Tissue Augmentation

Prospective, Open Label, Post Marketing Study of the Safety and Effectiveness of HArmonyCa Injectable Gel for Mid-face Soft Tissue Augmentation

NCT05119777•Allergan

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•HArmonyCa is contraindicated:
•1. in patients with a known sensitivity to any of the product components.
•2. in patients suffering from skin disease or abnormal skin conditions.
•3. in patients suffering from an infection or inflammation (either acute or chronic) at or near the treatment site.
•4. in patients susceptible to keloid formation, hypertrophic scarring, or developing inflammatory skin conditions.
•5. in patients with impaired wound healing due to systemic disorders, medicinal drugs, or unhealthy or poorly-vascularized tissue.
•6. in patients suffering from prolonged bleeding or tissue healing due to medical conditions or medicinal drugs.
•7. in patients with a history of anaphylactic reactions and/or multiple severe allergies.
•8. in patients with a known sensitivity to steroids, or who are contraindicated to be treated with steroids.
•9. for injection into the glabellar or periocular areas.
+23 more criteria

Locations (2)

Eurofins Dermscan Pharmascan /ID# 240921

Aix-en-Provence, France

Eurofins Pharmascan /ID# 240920

Lyon, France

Key Dates

Start Date

October 13, 2021

Primary Completion Date

September 15, 2023

Completion Date

September 15, 2023

Last Updated

September 19, 2024

Enrollment

140

ACTUAL participants

Conditions

Soft Tissue Augmentation

Interventions

HArmonyCa Injectable Gel

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

HArmonyCa Injectable Gel for Mid Face Soft Tissue Augmentation

Inclusion Criteria

Exclusion Criteria

Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique

Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site.

Porcine Derma for Soft Tissue Augmentation Around Implants

Pontic Site Soft Tissue Augmentation Using De-epithelized Connective Tissue Graft Versus Partially De-epithelized Connective Tissue Graft