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临床试验/NCT02342223
NCT02342223已完成1 期

Voluma Treatment of HIV Facial Lipoatrophy

Jared Jagdeo, MD, MS2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Percentage of Participants With Device or Procedure Related Adverse Events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Percentage of Participants With Device or Procedure Related Adverse Events

时间窗: 12 months

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).

Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator

时间窗: Baseline to 12 months

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."

次要结局

  • Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Participants(Baseline to 12 months)
  • Subject Satisfaction Questionnaire (SSQ)(12 months)
  • Dermatology Life Quality Index (DLQI)(Baseline to 12 months)
  • Number of Participants Achieving Grade 1 in the Carruthers Lipoatrophy Severity Scale (CLSS)(Baseline to 12 months)

研究者

发起方
Jared Jagdeo, MD, MS
申办方类型
Fed
责任方
Sponsor Investigator
主要研究者

Jared Jagdeo, MD, MS

Medical Physician

VA Northern California Health Care System

研究点 (2)

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