Phase 1
N=20
Voluma Filler Agent For The Treatment of HIV-associated Facial Lipoatrophy
HIV Facial Lipoatrophy
Bottom Line
View on ClinicalTrials.gov: NCT02342223 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator — 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Voluma (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jared Jagdeo, MD, MS
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator |
19 | — |
| PRIMARY Percentage of Participants With Device or Procedure Related Adverse Events |
42; 47; 21; 42; 0 | — |
| SECONDARY Number of Participants Achieving Grade 1 in the Carruthers Lipoatrophy Severity Scale (CLSS) |
19 | — |
| SECONDARY Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Participants |
19 | — |
| SECONDARY Subject Satisfaction Questionnaire (SSQ) |
100; 100; 100 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) |
1.6; 0.5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02342223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.