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

Study Identifier
M21-784
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Plain Language Summary
Available Language(s): English
Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Facial Aesthetics - Fillers
  • Study Drug
    N/A
    Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    YVR Aesthetics Training & Study Centre /ID# 239809
    Vancouver, British Columbia, Canada, V5Z 1H2
    Status
    Not applicable
    Location
    Humphrey & Beleznay Cosmetic Dermatology /ID# 239805
    Vancouver, British Columbia, Canada, V5Z 4E1
    Status
    Not applicable
    Location
    Pacific Derm /ID# 240785
    Vancouver, British Columbia, Canada, V6H 4E1
    Status
    Not applicable
    Location
    Skin Matters Medical Aesthetic Centre /ID# 239986
    Vancouver, British Columbia, Canada, V6M 4J2
    Status
    Not applicable
    Location
    Dermetics Cosmetic Dermatology /ID# 246536
    Burlington, Ontario, Canada, L7N 3N2
    Status
    Not applicable
    Location
    The Centre for Clinical Trials /ID# 246409
    Oakville, Ontario, Canada, L6J 7W5
    Status
    Not applicable
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