Status:
WITHDRAWN
Clinical Trial to Determine the Efficacy of Sculptra™ Dermal Filler for the Correction of Contour Deformities Caused by Lipoatrophy
Lead Sponsor:
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
Collaborating Sponsors:
Sanofi
Conditions:
Lipodystrophy
Emaciation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Lipoatrophy is a condition that affects certain individuals, most commonly those who are infected with the HIV virus. Lipoatrophy however can also affect individuals who suffer from recurrent systemic...
Detailed Description
Soft tissue fillers are used to temporarily fill facial lines and wrinkles and augment contour deformities. There are a variety of soft tissue fillers available. Sculptra™ has been used to correct de...
Eligibility Criteria
Inclusion
- Bilateral lipoatrophy corresponding to a visual grade 2 or above in the attached lipoatrophy scale.
- Available and willing to attend all follow-up visits.
- Age \> 18 years.
- Able and willing to give informed consent.
Exclusion
- Known allergy or sensitivity to Sculptra™, suture material or any material that in the investigator's opinion may cause an allergic reaction.
- The subject has received a soft tissue augmentation to the area to be treated within the last 6 months.
- Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study.
- The subject has received autologous fat transfer in the last 6 months.
- Subject is suffering from facial Kaposi's sarcoma.
- The subject has active skin diseases or inflammation on or near the area of injection, such as psoriasis, herpes zoster, infection, or discoid lupus.
- History of sensitivity to lidocaine.
- Pregnant or nursing. (Premenopausal or nonsurgically sterile women must have a negative urine pregnancy test and must be using an adequate method of birth control.)
- Subject has ever received an injection or implant of silicone in the area to be treated.
- Subject is currently on any metabolic augmentation medications such as anabolic steroids.
- Current use of anticoagulant therapy or has a history of hemorrhagic disorders.
- History of connective tissue disease or other related disorder that in the investigator's opinion excludes the subject from the study.
- Subject is involved in any other research study involving an investigational product, or has concluded a study less than 30 days ago.
- The subject is suffering from any medical condition or complication that in the investigator's opinion places the subject at risk by participating in the study.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00360139
End Date
December 1 2008
Last Update
August 21 2007
Active Locations (1)
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1
Dermatology Cosmetic Laser Associates of La Jolla
La Jolla, California, United States, 92103