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

Allergan

Status and phase

Active, not recruiting

Phase 3

Conditions

Mid Face Volume Deficit

Treatments

Device: HArmonyCa Lidocaine Injectable Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT05452070

M21-784

Details and patient eligibility

About

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.

Enrollment

171 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant must be in general good health.
Participant seeking soft tissue augmentation in the mid face.
Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Able, as assessed by the TI, and willing to follow study instructions (including compliance with the safety e-diary) and likely to complete all required study visits.

Exclusion criteria

Has experienced trauma to the face within 6 months before enrollment or has residual deficiencies, deformities, or scarring
Has active or recurrent inflammation or infection in either eye
Has tendency to develop hypertrophic scarring and/or keloid scarring
Has active autoimmune disease
Has current cutaneous or mucosal inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion, in the face
Has fat injection or permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face
Has temporary dermal filler injections in the face within 24 months before enrollment
Has semi-permanent fillers (eg, poly-L-lactic acid, CaHA) anywhere in the face within 36 months before enrollment
Has botulinum toxin treatment in cheek area (including crow's feet) within 6 months before enrollment
Has mesotherapy or cosmetic facial procedures in the face within 6 months before enrollment. Examples of mesotherapy or cosmetic facial procedures are face-lift, laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures
Has tattoos, piercings, facial hair, (unless willing to remove prior to each assessment visit) or scars in the face that would interfere with the visualization of the face for the effectiveness assessment
Undergone a dental procedure within 6 weeks before treatment or plan to undergo a dental procedure (other than prophylaxis or dental fillings) during the course of the study
History of an allergic reaction or significant sensitivity to constituents of the study investigational product (and its excipients) and/or other products in the same class (lidocaine [or any amide-based anesthetics], HA products, or Streptococcal protein).
Any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study.
Any live vaccine within 4 weeks prior to the first dose of study treatment, or expected need of live vaccination during study participation including at least 4 weeks after the last dose of study treatment.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

171 participants in 2 patient groups

HArmonyCa Lidocaine Injectable Gel

Experimental group

Description:

Participants will receive HArmonyCa Lidocaine Injectable Gel on 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.

Treatment:

Device: HArmonyCa Lidocaine Injectable Gel

Control Group

Other group

Description:

Participants will be followed for 3 months. Participants can opt to receive HArmonyCa Lidocaine Injectable Gel after 3 months and followed for up to 25 months.

Treatment:

Device: HArmonyCa Lidocaine Injectable Gel