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

HIV Facial Lipoatrophy Clinical Trial

Official title:

Voluma Treatment of HIV Facial Lipoatrophy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02342223
• Other study ID #: Allergan-97727
• Status: Active, not recruiting
• Phase: Phase 1
• First received: January 9, 2015
• Last updated: December 9, 2015
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: December 2015
• Source: VA Northern California Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facies
• HIV Facial Lipoatrophy
• Lipodystrophy

Intervention

Device:
• Voluma

Locations

Country	Name	City	State
United States	Sacramento VA Medical Center	Mather	California

Sponsors (4)

Lead Sponsor	Collaborator
Jared Jagdeo, MD, MS	Allergan, East Bay Institute for Research and Education, VA Northern California Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Global Aesthetic Improvement Scale (GAIS) by principal 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/post intervention photography by principal investigator (PI).	12 months	No
Primary	Number of participants with 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	Yes
Secondary	Changes 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).	12 months	No
Secondary	Changes in the Global Aesthetic Improvement Scale (GAIS) by subjects	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/post intervention photography by subjects.	12 months	No
Secondary	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.	12 months	No
Secondary	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).	12 months	No