Overview

This trial is active, not recruiting.

Condition hiv facial lipoatrophy
Treatment voluma
Phase phase 1
Sponsor Jared Jagdeo, MD, MS
Collaborator Allergan
Start date February 2015
End date September 2016
Trial size 20 participants
Trial identifier NCT02342223, Allergan-97727

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
voluma 20 mg/ml hyaluronic acid-based dermal filler

Primary Outcomes

Measure
Changes in the Global Aesthetic Improvement Scale (GAIS) by principal investigator
time frame: 12 months
Number of participants with adverse events
time frame: 12 months

Secondary Outcomes

Measure
Changes in the Carruthers Lipoatrophy Severity Scale (CLSS)
time frame: 12 months
Changes in the Global Aesthetic Improvement Scale (GAIS) by subjects
time frame: 12 months
Subject Satisfaction Questionnaire (SSQ)
time frame: 12 months
Dermatology Life Quality Index (DLQI)
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Voluma Treatment of HIV Facial Lipoatrophy
Principal investigator Jared Jagdeo, MD, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by VA Northern California Health Care System.