Clinical trial NCT02342223: Voluma Filler Agent For The Treatment of HIV-associated Facial Lipoatrophy
Official title: Voluma Treatment of HIV Facial Lipoatrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Facial Lipoatrophy
Keywords: human immunodeficiency virus
facial lipoatrophy
facial lipodystrophy
hyaluronic acid
dermal filler
filler agent
Lead sponsor: VA Northern California Health Care System
Sponsor class: FED
Collaborators: name: Allergan
name: VA Northern California Health Care System
name: East Bay Institute for Research and Education
First posted: 2015-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator
timeFrame: Baseline to 12 months
measure: Percentage of Participants With Device or Procedure Related Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Achieving Grade 1 in the Carruthers Lipoatrophy Severity Scale (CLSS)
timeFrame: Baseline to 12 months
measure: Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Participants
timeFrame: Baseline to 12 months
measure: Subject Satisfaction Questionnaire (SSQ)
timeFrame: 12 months
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Mather
country: United States
facility: Sacramento VA Medical Center
state: California
Study officials:
affiliation: Sacramento VA Medical Center - Dermatology Service
name: Jared Jagdeo, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang AS, Babalola O, Jagdeo J. The "smile-and-fill" injection technique: a dynamic approach to midface volumization. J Drugs Dermatol. 2014 Mar;13(3):288-90.
citation: Bechara FG, Gambichler T, Brockmeyer NH, Sand M, Altmeyer P, Hoffmann K. Hyaluronic acid new formulation: experience in HIV-associated facial lipoatrophy. Dermatology. 2008;217(3):244-9. doi: 10.1159/000148252. Epub 2008 Jul 25.
citation: Ho D, Jagdeo J. Patient Reported Outcomes from HIV Facial Lipoatrophy Treatment With a Volumizing Hyaluronic Acid Filler: A Prospective, Open-Label, Phase I and II Study. J Drugs Dermatol. 2016 Sep 1;15(9):1064-9.