Status:
COMPLETED
Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid
Lead Sponsor:
Canadian Immunodeficiency Research Collaborative
Collaborating Sponsors:
Pur Medical Corporation
Conditions:
Human Immunodeficiency Virus
Facial Lipoatrophy
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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 re...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00333684
Start Date
December 1 2004
End Date
May 1 2010
Last Update
June 5 2012
Active Locations (1)
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1
Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5B 1L6