NCT02342223

Voluma Filler Agent For The Treatment of HIV-associated Facial Lipoatrophy

Voluma Treatment of HIV Facial Lipoatrophy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Jared Jagdeo, MD, MS · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of Voluma and see what effects it has on HIV facial lipoatrophy. The hypothesis is that Voluma will be safe, efficacious and positively impact the quality-of-life in the treatment of facial lipoatrophy in patients with HIV.

Detailed description

HIV facial lipoatrophy (volume loss) is an increasing concern with patients on Highly Active Anti-Retroviral Therapy (HAART) because it affects the quality-of-life and adherence to medication regimen. Treatment of HIV facial lipoatrophy helps to improve patient wellness by removing the social stigma associated with HIV facial lipoatrophy. Currently, there are few medical therapies that can treat HIV facial lipoatrophy and are FDA-approved for this indication. Juvéderm Voluma (Allergan) may benefit patients on HAART because it may provide a more immediate aesthetic enhancement and potentially has fewer adverse effects, which results in a more natural appearing facial enhancement outcome. Voluma is the only agent that is FDA-approved for facial volume loss. We anticipate Voluma having less adverse effects than current FDA-approved drugs for HIV lipoatrophy as Voluma is a hyaluronic acid (HA)-based agent. The benefit of using hyaluronidase to "correct" or "modify" facial HA-based volume therapy is also a benefit for HIV patients, which currently does not exist as a post-injection modification option for other FDA-approved filling agents used to treat patients with HIV facial lipoatrophy. Voluma is currently FDA-approved for correction of age-related volume loss in the midface, and there's no alteration in the chemical or biophysical properties of Voluma that is being used in our proposed study. In addition to conventional injection techniques, we will implement the 'smile and fill' technique pioneered by our clinical research group to achieve better mid-face aesthetic outcomes.

Conditions

• HIV Facial Lipoatrophy

Interventions

Type	Name	Description
DEVICE	Voluma

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-01-19
• Last updated: 2017-01-16
• Results posted: 2017-01-16

Locations

1 site across 1 country: United States