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Mather, California 95655


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Aged 18 years or more with laboratory evidence of HIV-1 infection and have been on HAART therapy for at least 1 (one) year. - Not to have AIDS (CD4 count < 250) or AIDS-defining illness. - Bilateral lipoatrophy corresponding to a visual grade 2 or above in the attached Carruthers Lipoatrophy Severity Scale (CLSS). - Available and willing to attend study follow-up visits. - Able and willing to give informed consent. Exclusion Criteria: - Any active skin inflammation or infection in or near the treatment area. - Hypersensitivity to the components of Voluma. - Previous treatment with Voluma or any other product for facial lipoatrophy within the past year. - Has known bleeding disorder - History of keloid formation - Currently receiving systemic corticosteroids or anabolic steroids - Currently on known anticoagulants (i.e. aspirin, non-steroidal anti-inflammatory drugs) - Pregnancy or breastfeeding or anticipating becoming pregnant during the study period. - Any other excluding factors that, according to the investigator's judgment, would preclude enrollment in the study. - Any condition that may interfere with ability to comply with study requirements.


NCT ID:

NCT02342223


Primary Contact:

Principal Investigator
Jared Jagdeo, MD, MS
Sacramento VA Medical Center - Dermatology Service


Backup Contact:

N/A


Location Contact:

Mather, California 95655
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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