- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02342223
Voluma Filler Agent For The Treatment of HIV-associated Facial Lipoatrophy
Voluma Treatment of HIV Facial Lipoatrophy
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Mather, California, United States, 95655
- Sacramento VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Voluma
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. |
Other Names:
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What is the study measuring?
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
Time Frame: Baseline to 12 months
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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."
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Baseline to 12 months
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Percentage of Participants With Device or Procedure Related Adverse Events
Time Frame: 12 months
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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).
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Achieving Grade 1 in the Carruthers Lipoatrophy Severity Scale (CLSS)
Time Frame: Baseline to 12 months
|
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.
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Baseline to 12 months
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Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Participants
Time Frame: 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 participants.
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Baseline to 12 months
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Subject Satisfaction Questionnaire (SSQ)
Time Frame: 12 months
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To evaluate the benefits and effects of Voluma injections on HIV-associated facial lipoatrophy as evidenced by the subject satisfaction questionnaire.
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12 months
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Dermatology Life Quality Index (DLQI)
Time Frame: Baseline to 12 months
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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.
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Baseline to 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jared Jagdeo, MD, MS, Sacramento VA Medical Center - Dermatology Service
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Allergan-97727
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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