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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Voluma Treatment of HIV Facial Lipoatrophy

Conditions
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HIV Facial Lipoatrophy

Intervention / Treatment
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* Device: Voluma


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Voluma<br>Subjects will be screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and will receive subcutaneous injections of Voluma in the affected facial areas with the 'smile and fill' technique (Jagdeo 2014) based on Carruthers scoring scale. Subjects with Carruthers Score level 2 will receive total of 2-6 syringes of Voluma. Subjects with Carruthers Score level 3 will receive total of 4-8 syringes of Voluma. Subjects with Carruthers Score level 4 will receive total of 6-12 syringes of Voluma. All subjects will receive one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment. | Device: Voluma<br> <br> * Other names: 20 mg/ml hyaluronic acid-based dermal filler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator | To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by assessing changes in the Global Aesthetic Improvement Scale (GAIS) based on pre- and post-treatment photography by principal investigator (PI). GAIS is a 5-point rating scale, ranging from worse, no change, improved, much improved, and very much improved. | Baseline to 12 months | 
| Percentage of Participants With Device or Procedure Related Adverse Events | To evaluate the safety of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by monitoring the incidence of adverse events (patient will keep a daily diary for initial 1 month and weekly phone calls will be made by study coordinator for initial 1 month to document possible adverse events, including injection site reactions, redness, bruising, swelling, and induration). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving Grade 1 in the Carruthers Lipoatrophy Severity Scale (CLSS) | To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated lipoatrophy over 12 months by assessing changes in the Carruthers Lipoatrophy Severity Scale (CLSS) based on pre/post intervention photography by principal investigator (PI). CLSS is a 4-point grading scale (1 to 4, with a greater number indicating higher severity of HIV FLA). Grade 1: mild and localized facial lipoatrophy. Grade 2: deeper and longer atrophy, with the facial muscles beginning to show through. Grade 3: atrophic area is even deeper and wider, with the muscles clearly showing. Grade 4: lipoatrophy covers a wide area, extending up toward the eye sockets, and the facial skin lies directly on the muscles. | Baseline to 12 months | 
| Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Participants | To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by assessing changes in the Global Aesthetic Improvement Scale (GAIS) based on pre- and post- treatment photography by participants. | Baseline to 12 months | 
| Subject Satisfaction Questionnaire (SSQ) | To evaluate the benefits and effects of Voluma injections on HIV-associated facial lipoatrophy as evidenced by the subject satisfaction questionnaire. | 12 months | 
| Dermatology Life Quality Index (DLQI) | To evaluate the effects of Voluma injections on the subject's quality of life (QOL) using the Dermatology Life Quality Index (DLQI). The DLQI is a validated 10-item questionnaire encompassing six different domains of QOL, including symptoms and feelings, daily activities, leisure, work/school, personal relationships, and treatment. Each question has four possible responses: not at all/not relevant, a little, a lot, and very much that corresponds to scores of 0, 1, 2, and 3, respectively, and a higher score suggests a higher level of QOL impairment. DLQI total score may range between 0 to 30. | Baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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facial lipoatrophy, human immunodeficiency virus, facial lipodystrophy, hyaluronic acid, dermal filler, filler agent