A Study Evaluating JUV DERM VOLUMA XC Injectable Gel for Correction of Temple Hollowing in Adult Participants Over 22 Years Old

  • STATUS
    Recruiting
  • participants needed
    213
  • sponsor
    Allergan
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Updated on 19 February 2024
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Summary

The objectives of this study are to evaluate the safety and effectiveness of Juvederm Voluma XC injectable gel in adult participants seeking correction of temple hollowing

Details
Condition Temple Hollowing
Age 22years - 100years
Treatment JUVÉDERM VOLUMA® XC
Clinical Study IdentifierNCT04414397
SponsorAllergan
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participants in general good health
Participants seeking improvement of temple hollowing

Exclusion Criteria

Temple hollowing due to trauma, congenital malformations, or lipodystrophy, either congenital or acquired
Experienced trauma to the temple area within 6 months before enrollment or has residual deficiencies, deformities, or scarring
Temporal arteritis or history of temporal arteritis
Temporomandibular joint dysfunction or any other jaw issues
Recurrent temporal headaches such as temporal tendinitis migraine
Active or recurrent inflammation or infection in either eye
Tendency to develop hypertrophic scarring
Active autoimmune disease
History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
Current cutaneous or mucosal inflammatory or infectious processes (e.g. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion, above the subnasal
History of detached retina, retinal vascular occlusion (eg, vein or arterial occlusion), narrow angle glaucoma, neovascular eye disease, or severely impaired/absent eye function in 1 or both eyes
Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy)
Fat injection or permanent facial implants anywhere in the face
Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment
Temporary dermal filler injections above the subnasale within 24 months before enrollment
Mesotherapy or cosmetic facial procedures above the subnasale 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
Injections in the nasolabial fold are acceptable only if done at least 3 months prior to enrollment
Botulinum toxin treatment above the subnasale within 6 months before enrollment
Has braces or other orthodontics or is planning such treatment during the study
Not eligible for this study if participants have begun using any new over the counter or prescription oral or tropical, anti-wrinkle products above the subnasale within 30 days before enrollment or are planning to begin using such products during the study. Participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study
Is on a regimen of anti-coagulation therapy (eg, warfarin, clopidogrel)
Has tattoos, piercings, facial hair, or scars above and including the subnasale that would interfere with visual assessment of the temple
Females who are pregnant, nursing, or planning a pregnancy
Plans a significant weight change (more than 10% of body weight) during the study
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