CompletedPhase 4

HArmonyCa Injectable Gel for Mid Face Soft Tissue Augmentation

France140 participantsStarted 2021-10-13

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 1 Month

Trial details

NCT IDNCT05119777

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-15

View on ClinicalTrials.gov More Soft Tissue Augmentation trials