A Study to Assess Safety and Effectiveness of HArmonyCa Lidocaine Injectable Gel for Restoration and/or Creation of Mid-Face Volume in Adult Participants

Study Identifier
M21-782
CT.gov Identifier
NCT07032597
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Facial Aesthetics - Fillers
    • Study Drug
    N/A
    Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the Mid-face Volume Deficit Scale (MFVDS) 5-point photonumeric scale based on evaluating investigator (EI) live assessment at randomization visit. * Mid-face areas are amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgment. * Must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active pandemic infection.
    Exclusion Criteria:
    * Excessive skin laxity in the mid-face area in the opinion of the TI. * Significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area. * Semi-permanent soft tissue filler treatment (e.g., CaHA, poly-L-lactic acid) in the face within 36 months before randomization.

    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 compared to Restylane® Perlane® Lidocaine (Perlane) in adults seeking restoration and/or correction of moderate to severe mid-face volume deficit.

    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 receive active comparator, Perlane. Around 252 adult participants seeking restoration and/or creation of mid-face volume will be enrolled in the study at approximately 9 sites in China.

    Participants will receive HArmonyCa Lidocaine injectable gel or Perlane at Day 1 with an option touch-up treatment on Day 31. Participants will be followed for up to 12 Months after last treatment.

    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. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Beijing Hospital /ID# 272476
    Beijing, Beijing Municipality, China, 100005
    Status
    Not applicable
    Location
    Peking Union Medical College Hospital (West) - Xidan Campus /ID# 272480
    Beijing, Beijing Municipality, China, 100032
    Status
    Not applicable
    Location
    Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 272631
    Wuhan, Hubei, China, 430022
    Status
    Not applicable
    Location
    Nanjing Drum Tower Hospital /ID# 272468
    Nanjing, Jiangsu, China, 210008
    Status
    Not applicable
    Location
    Zhongda Hospital Southeast University /ID# 272471
    Nanjing, Jiangsu, China, 210009
    Status
    Not applicable
    Location
    Wuxi People'S Hospital /ID# 275928
    Wuxi, Jiangsu, China, 214023
    Status
    Not applicable
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