Clinical Trial to Determine the Efficacy of Sculptra™ Dermal Filler for the Correction of Contour… (NCT00360139) | Clinical Trial Compass
WithdrawnPhase 4
Clinical Trial to Determine the Efficacy of Sculptra™ Dermal Filler for the Correction of Contour Deformities Caused by Lipoatrophy
United States15 participants
Plain-language 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 infections, those who have a weakened immune system, or certain patients who suffer from cancer or receive chemotherapeutics. In contrast, lipoatrophy can sometimes be present in individuals who are perfectly healthy but have genetically predisposing factors that can contribute to facial emaciation or lipoatrophy.
The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume. These often elastic contour fillers (also known as soft tissue augmentation devices) can correct hollowness around the eyes, add fullness to thin lips, balance a disproportionate face or correct topographical anomalies.
This study aims to:
* Objectively measure the improvement of contour-deformities after Sculptra™ injection from baseline to study closure by utilizing the Primos™ photographic/topographical measuring system.
* Evaluate the efficacy, longevity and duration of volume-correction in subjects which are both HIV positive and HIV negative.
* Assess the safety of Scupltra™ dermal filler when used to correct volume deformities caused by lipoatrophy in subjects that are HIV negative.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Volume correction and longevity of correction
Timeframe: at 12 and 24 months
Trial details
NCT IDNCT00360139
SponsorDermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
. 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.)