Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid
Human Immunodeficiency Virus, Facial Lipoatrophy
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus
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
Sites / Locations
- Maple Leaf Medical Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
receive bioalcamid at baseline
Receive bioalcamid at 24 weeks
half subjects received bioalcamid at baseline
other half of subjets received bioalcamid at 24 weeks