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

June 4, 2012 updated by: Canadian Immunodeficiency Research Collaborative

A Prospective Study Evaluating the Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid Soft Tissue Endoprosthesis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1L6
        • Maple Leaf Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: receive bioalcamid at baseline
half subjects received bioalcamid at baseline
Device: BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS
prosthetic bioalcamid was injected- amounts determined by the plastic surgeon and depended individual needs
Active Comparator: Receive bioalcamid at 24 weeks
other half of subjets received bioalcamid at 24 weeks
Device: BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS
prosthetic bioalcamid was injected- amounts determined by the plastic surgeon and depended individual needs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate Quality of Life using the slightly modified Dermatology Quality Life Survey and the MOS-HIV Survey.
Time Frame: 96 weeks
To evaluate Quality of Life using the slightly modified Dermatology Quality Life Survey and the MOS-HIV Survey.
96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate 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
valuate the safety and efficacy of Bioalcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy.
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Immunodeficiency Research Collaborative

Collaborators

Pur Medical Corporation

Investigators

  • Principal Investigator: Mona Loutfy, MD, FRCP(C), Canadian Immunodeficiency Research Collaborative

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria

June 2, 2006

First Posted (Estimate)

June 6, 2006

Study Record Updates

Last Update Posted (Estimate)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 4, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LA-BA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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