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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02342223
Recruitment Status : Completed
First Posted : January 19, 2015
Results First Posted : January 16, 2017
Last Update Posted : January 16, 2017
Sponsor:
Collaborators:
Allergan
VA Northern California Health Care System
East Bay Institute for Research and Education
Information provided by (Responsible Party):
Jared Jagdeo, MD, MS, VA Northern California Health Care System

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Facial Lipoatrophy
Intervention Device: Voluma
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Voluma Treatment of HIV Facial Lipoatrophy
Hide Arm/Group Description

Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the "smile and fill" technique (Jagdeo 2014) based on Carruthers scoring scale.

All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment.

Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Voluma
Hide Arm/Group Description

Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the "smile and fill" technique (Jagdeo 2014) based on Carruthers scoring scale.

All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
57  (10)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
0
   0.0%
Male
20
 100.0%
1.Primary Outcome
Title Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator
Hide Description 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."
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Voluma
Hide Arm/Group Description:

Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the "smile and fill" technique (Jagdeo 2014) based on Carruthers scoring scale.

All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment.

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
19
2.Primary Outcome
Title Percentage of Participants With Device or Procedure Related Adverse Events
Hide Description 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).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Common, transient adverse events reported in subject diaries include as follows.
Arm/Group Title Voluma
Hide Arm/Group Description:

Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the "smile and fill" technique (Jagdeo 2014) based on Carruthers scoring scale.

All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment.

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of total participants
Ecchymosis 42
Edema 47
Tenderness 21
Pain 42
Permanent Treatment Related AE 0
3.Secondary Outcome
Title Number of Participants Achieving Grade 1 in the Carruthers Lipoatrophy Severity Scale (CLSS)
Hide Description 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.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Voluma
Hide Arm/Group Description:

Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the "smile and fill" technique (Jagdeo 2014) based on Carruthers scoring scale.

All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment.

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
19
4.Secondary Outcome
Title Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Participants
Hide Description 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.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Voluma
Hide Arm/Group Description:

Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the "smile and fill" technique (Jagdeo 2014) based on Carruthers scoring scale.

All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment.

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
19
5.Secondary Outcome
Title Subject Satisfaction Questionnaire (SSQ)
Hide Description To evaluate the benefits and effects of Voluma injections on HIV-associated facial lipoatrophy as evidenced by the subject satisfaction questionnaire.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Voluma
Hide Arm/Group Description:

Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the "smile and fill" technique (Jagdeo 2014) based on Carruthers scoring scale.

All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment.

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of total participants
“Has this treatment been beneficial to you?” 100
“Would you get this treatment again?” 100
“Would you recommend this treatment to others?” 100
6.Secondary Outcome
Title Dermatology Life Quality Index (DLQI)
Hide Description 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.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Voluma
Hide Arm/Group Description:

Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the "smile and fill" technique (Jagdeo 2014) based on Carruthers scoring scale.

All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment.

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline 1.6  (3.0)
12-months post-treatment 0.5  (1.2)
Time Frame [Not Specified]
Adverse Event Reporting Description Common, transient adverse events were documented and reported in subject diaries.
 
Arm/Group Title Voluma
Hide Arm/Group Description

Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the "smile and fill" technique (Jagdeo 2014) based on Carruthers scoring scale.

All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment.

All-Cause Mortality
Voluma
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Voluma
Affected / at Risk (%) # Events
Total   0/19 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Voluma
Affected / at Risk (%) # Events
Total   9/19 (47.37%)    
Injury, poisoning and procedural complications   
Ecchymosis   8/19 (42.11%)  19
Edema   9/19 (47.37%)  19
Tenderness   4/19 (21.05%)  19
Pain   8/19 (42.11%)  19
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jared Jagdeo, MD, MS
Organization: VA Northern California Health Care System
Phone: 917-837-9796
EMail: jrjagdeo@gmail.com
Layout table for additonal information
Responsible Party: Jared Jagdeo, MD, MS, VA Northern California Health Care System
ClinicalTrials.gov Identifier: NCT02342223    
Other Study ID Numbers: Allergan-97727
First Submitted: January 9, 2015
First Posted: January 19, 2015
Results First Submitted: August 4, 2016
Results First Posted: January 16, 2017
Last Update Posted: January 16, 2017