NCT02342223

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
9 months until next milestone

Results Posted

Study results publicly available

January 16, 2017

Completed
Last Updated

January 16, 2017

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

January 9, 2015

Results QC Date

August 4, 2016

Last Update Submit

November 21, 2016

Conditions

HIV Facial Lipoatrophy

Keywords

human immunodeficiency virusfacial lipoatrophyfacial lipodystrophyhyaluronic aciddermal fillerfiller agent

Outcome Measures

Primary Outcomes (2)

  • 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."

    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).

    12 months

Secondary Outcomes (4)

  • Number of Participants Achieving Grade 1 in the Carruthers Lipoatrophy Severity Scale (CLSS)

    Baseline to 12 months

  • 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

Study Arms (1)

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.

Device: Voluma

Interventions

VolumaDEVICE
Also known as: 20 mg/ml hyaluronic acid-based dermal filler
Voluma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sacramento VA Medical Center

Mather, California, 95655, United States

Location

Related Publications (3)

  • 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.

    PMID: 24595573RESULT

  • 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.

    PMID: 18663308RESULT

  • 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.

    PMID: 27602967DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Jared Jagdeo, MD, MS
Organization
VA Northern California Health Care System
jrjagdeo@gmail.com
917-837-9796

Study Officials

  • Jared Jagdeo, MD, MS

    Sacramento VA Medical Center - Dermatology Service

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Physician

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 19, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 16, 2017

Results First Posted

January 16, 2017

Record last verified: 2016-11

Locations

US(1)