HIV Facial LipoatrophyPhase 1NCT02342223

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

A Phase 1 study testing Voluma in people with HIV Facial Lipoatrophy, run by Jared Jagdeo, MD, MS at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Facial Lipoatrophy
What is being tested?: Voluma
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Feb 2015to May 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sacramento VA Medical Center
Mather, California, 95655

Other trials in United States

About this study

Official title: Voluma Treatment of HIV Facial Lipoatrophy

Read the detailed 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.

Conditions: HIV Facial Lipoatrophy
Being tested: Voluma
Keywords: human immunodeficiency virus, facial lipoatrophy, facial lipodystrophy, hyaluronic acid, dermal filler, filler agent
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VolumaDevice
Also called 20 mg/ml hyaluronic acid-based dermal filler

Study groups in NCT02342223
Study group	Role	What they receive
Voluma	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. Receives: Device: Voluma

What is being measured

The primary outcome is the main question the study is designed to answer.

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."
Measured: 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).
Measured: 12 months

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015May 2016

First posted19 Jan 2015 (estimated)
Study startFeb 2015
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HIV Facial LipoatrophyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02342223
Sponsor's protocol ID: Allergan-97727
Status last verified: Nov 2016
First submitted: 9 Jan 2015
Last updated: 16 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 24595573
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.
PubMed 18663308
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.
PubMed 27602967

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Voluma Treatment of HIV Facial Lipoatrophy
ClinicalTrials.gov ID: NCT02342223
Acronym / sponsor ID: Allergan-97727
Conditions: HIV Facial Lipoatrophy
Keywords: human immunodeficiency virus, facial lipoatrophy, facial lipodystrophy, hyaluronic acid, dermal filler, filler agent
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Jared Jagdeo, MD, MSUS federal agency
Collaborators: Allergan, VA Northern California Health Care System, East Bay Institute for Research and Education
Study start: Feb 2015
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 19 Jan 2015 (estimated)
Results: Posted 16 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Voluma	Experimental	Device: VolumaSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VolumaAlso: 20 mg/ml hyaluronic acid-based dermal filler	Device	Voluma

Primary outcome

Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator
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 principal investigator (PI). GAIS is a 5-point rating scale, ranging from "worse, no change, improved, much improved, and very much improved."
Percentage of Participants With Device or Procedure Related Adverse Events
Time frame: 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).

4 secondary outcomes

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

Results and safety

Results posted to the registry on 16 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Voluma Treatment of HIV Facial Lipoatrophy	20	19

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

Time frame: Baseline to 12 months. Number. Unit: participants

Measure	Voluma n = 19
Value	19

Primary outcome: Percentage of Participants With Device or Procedure Related Adverse Events

Time frame: 12 months. Number. Unit: percentage of total participants

Measure	Voluma n = 19
Ecchymosis	42
Edema	47
Tenderness	21
Pain	42
Permanent Treatment Related AE	0

Population analysed: Common, transient adverse events reported in subject diaries include as follows.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Voluma	0 of 19 (0%)	9 of 19 (47.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24595573Wang 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.
Results publication: PubMed 18663308Bechara 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.
Derived from this study: PubMed 27602967Ho 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jared Jagdeo, MD, MS principal investigator

Sacramento VA Medical Center - Dermatology Service

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Voluma in people with HIV Facial Lipoatrophy, run by Jared Jagdeo, MD, MS at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02342223, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.