M21-784 - HArmonyCa Lidocaine Injectable Gel for Mid Face Soft Tissue
Research type
Research Study
Full 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
IRAS ID
310645
Contact name
Christine Murphy
Contact email
Sponsor organisation
AbbVie UK
Duration of Study in the UK
3 years, 8 months, 18 days
Research 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 month3. The control group will participate in the study for up to 25 months.REC name
London - Hampstead Research Ethics Committee
REC reference
22/LO/0338
Date of REC Opinion
5 Aug 2022
REC opinion
Further Information Favourable Opinion