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Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid

Primary Purpose

Human Immunodeficiency Virus, Facial Lipoatrophy

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS
Sponsored by
Canadian Immunodeficiency Research Collaborative
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have moderate to severe levels of facial lipoatrophy determined by the three investigstors If female of child-bearing potential (not menopausal for at least 1 year nor surgically sterile), have a negative urine pregnancy test prior to any study treatments and be willing to use oral contraception or another medically acceptable form of contraception for the duration of the study Be able to understand and comply with the requirements of this study Be willing and able to provide written Informed Consent prior to any study-related procedures being performed Agree to refrain from seeking other treatment for lipoatrophy in the facial area while participating in this study Exclusion Criteria: Are pregnant, lactating, or trying to become pregnant Had prior therapy (e.g., other permanent or biodegradable injectable fillers or surgical correction such as a face-lift, etc.) within 9 months prior to entry into the study or are planning to undergo such therapy during the study Have any active inflammation, infection, or unhealed wound of the face Have any contraindicated condition described in the package insert for the product to be administered. Have a history of anaphylaxis or multiple severe allergies. Have planned relocation during the study, which would make follow-up visits impossible during the course of the study Used aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to initial or touch-up treatment or are taking concomitant anticoagulant therapy, anti-platelet therapy, or have a history of bleeding disorders Used over-the-counter wrinkle products (e.g., alpha-hydroxy acids) or prescription treatments (e.g., Renova, Retin-A, microdermabrasion, chemical peels) in the facial area within 4 weeks prior to study start. In addition, participants will be restricted from using over-the-counter wrinkle products or prescription treatments to the facial area for the duration of the study. Have received any investigational product within 30 days prior to study enrollment or are planning to receive other investigational products during the study

Sites / Locations

  • Maple Leaf Medical Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

receive bioalcamid at baseline

Receive bioalcamid at 24 weeks

Arm Description

half subjects received bioalcamid at baseline

other half of subjets received bioalcamid at 24 weeks

Outcomes

Primary Outcome Measures

To evaluate Quality of Life using the slightly modified Dermatology Quality Life Survey and the MOS-HIV Survey.
To evaluate Quality of Life using the slightly modified Dermatology Quality Life Survey and the MOS-HIV Survey.

Secondary Outcome Measures

Evaluate the safety and efficacy of Bioalcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy.
valuate the safety and efficacy of Bioalcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy.

Full Information

First Posted
June 2, 2006
Last Updated
June 4, 2012
Sponsor
Canadian Immunodeficiency Research Collaborative
Collaborators
Pur Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00333684
Brief Title
Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid
Official Title
A Prospective Study Evaluating the Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid Soft Tissue Endoprosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Immunodeficiency Research Collaborative
Collaborators
Pur Medical Corporation

4. Oversight

5. Study Description

Brief Summary
Evaluate and record any changes in the Quality of Life and psychological state of the affected study group following treatment with Bio-Alcamid. Evaluate the safety and efficacy of Bio-Alcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy. Pre-treatment classification and post treatment recording of changes will be performed by, both, the Principal Investigator and the Treatment Specialist and independently by a 'Blinded' Co-Investigator at post treatment Week 12. Safety data for Bio-Alcamid will be collected throughout the duration of the study. Safety will be determined by the rates of procedure-related events and adverse experiences associated with the use of Bio-Alcamid.
Detailed Description
Thirty (30) participants in the randomized portion of the study will be selected who have been classified as having moderate to severe facial lipoatrophy based on the three investigators evaluations. These patients will be divided into two groups - The Treatment Group - 15: At Day -1, the Treatment group will be established by the inclusion/exclusion criteria and consent forms will be signed. At Day 0 they will complete QOL Surveys and will receive treatment with Bio-Alcamid in the affected facial area(s). At Day 7, they will return to complete the QOL Surveys and allow the CITS to determine if a touch-up is necessary. If so, one touch-up session is permitted at week 6. The participants will again complete QOL Surveys and have efficacy assessments at week 12. The Treatment Group will continue with follow-up sessions at week 24, 48, 60 and at 96 weeks. Professional clinical photographs will be taken at each visit. The Control Group - 15: At Day -1, the Control group will be established by the inclusion/exclusion criteria and consent forms will be signed. At Day 0, they will complete QOL Surveys. They will return for visits at baseline and week 6 as well to complete QOL Surveys. At Week 12, they will complete the QOL Surveys and will receive a BA treatment. At Week 13, they will return to complete the QOL Surveys and allow the CITS to determine if a touch-up is necessary. If so, one touch-up session is permitted at week 18. If not, these participants will again complete QOL Surveys and have efficacy assessments at week 24. The Control Group will continue with follow-up sessions at week 48, 60, 96 and at 104 weeks. Professional clinical photographs will be taken at each visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Facial Lipoatrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
receive bioalcamid at baseline
Arm Type
Active Comparator
Arm Description
half subjects received bioalcamid at baseline
Arm Title
Receive bioalcamid at 24 weeks
Arm Type
Active Comparator
Arm Description
other half of subjets received bioalcamid at 24 weeks
Intervention Type
Device
Intervention Name(s)
BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS
Intervention Description
prosthetic bioalcamid was injected- amounts determined by the plastic surgeon and depended individual needs
Primary Outcome Measure Information:
Title
To evaluate Quality of Life using the slightly modified Dermatology Quality Life Survey and the MOS-HIV Survey.
Description
To evaluate Quality of Life using the slightly modified Dermatology Quality Life Survey and the MOS-HIV Survey.
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
Evaluate the safety and efficacy of Bioalcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy.
Description
valuate the safety and efficacy of Bioalcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy.
Time Frame
96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have moderate to severe levels of facial lipoatrophy determined by the three investigstors If female of child-bearing potential (not menopausal for at least 1 year nor surgically sterile), have a negative urine pregnancy test prior to any study treatments and be willing to use oral contraception or another medically acceptable form of contraception for the duration of the study Be able to understand and comply with the requirements of this study Be willing and able to provide written Informed Consent prior to any study-related procedures being performed Agree to refrain from seeking other treatment for lipoatrophy in the facial area while participating in this study Exclusion Criteria: Are pregnant, lactating, or trying to become pregnant Had prior therapy (e.g., other permanent or biodegradable injectable fillers or surgical correction such as a face-lift, etc.) within 9 months prior to entry into the study or are planning to undergo such therapy during the study Have any active inflammation, infection, or unhealed wound of the face Have any contraindicated condition described in the package insert for the product to be administered. Have a history of anaphylaxis or multiple severe allergies. Have planned relocation during the study, which would make follow-up visits impossible during the course of the study Used aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to initial or touch-up treatment or are taking concomitant anticoagulant therapy, anti-platelet therapy, or have a history of bleeding disorders Used over-the-counter wrinkle products (e.g., alpha-hydroxy acids) or prescription treatments (e.g., Renova, Retin-A, microdermabrasion, chemical peels) in the facial area within 4 weeks prior to study start. In addition, participants will be restricted from using over-the-counter wrinkle products or prescription treatments to the facial area for the duration of the study. Have received any investigational product within 30 days prior to study enrollment or are planning to receive other investigational products during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Loutfy, MD, FRCP(C)
Organizational Affiliation
Canadian Immunodeficiency Research Collaborative
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maple Leaf Medical Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1L6
Country
Canada

12. IPD Sharing Statement

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Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid

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