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COMPLETED
NCT05452070
PHASE3

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

Sponsor: Allergan

View on ClinicalTrials.gov

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.

Official title: An International, Multicenter, Evaluator-blinded, Randomized, Parallel-Group, Controlled Study of the Safety and Effectiveness of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft Tissue Augmentation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

171

Start Date

2022-09-02

Completion Date

2025-05-08

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DEVICE

HArmonyCa Lidocaine Injectable Gel

Subdermal or deep dermal injection

Locations (12)

YVR Aesthetics Training & Study Centre /ID# 239809

Vancouver, British Columbia, Canada

Humphrey & Beleznay Cosmetic Dermatology /ID# 239805

Vancouver, British Columbia, Canada

Pacific Derm /ID# 240785

Vancouver, British Columbia, Canada

Skin Matters Medical Aesthetic Centre /ID# 239986

Vancouver, British Columbia, Canada

Dermetics Cosmetic Dermatology /ID# 246536

Burlington, Ontario, Canada

The Centre for Clinical Trials /ID# 246409

Oakville, Ontario, Canada

Bertucci MedSpa Inc. /ID# 246496

Woodbridge, Ontario, Canada

Erevna Innovations Inc. /ID# 240401

Westmount, Quebec, Canada

Instituto Medico Miramar /ID# 240939

Málaga, Malaga, Spain

WM Hospitals /ID# 245747

Barcelona, Spain

Dr Nestor's Medical Cosmetic Centre /ID# 246406

Edinburgh, United Kingdom

MediZen /ID# 240102

Sutton Coldfield, United Kingdom