Clinical Trial to Determine the Efficacy of Sculptra™ Dermal Filler for the Correction of Contour Deformities Caused by Lipoatrophy
Public ClinicalTrials.gov record NCT00360139. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IV, Prospective, Non-Blinded, Non-Randomized, Single-Center Clinical Trial to Determine the Longevity, Duration, and Volume-Correcting Efficacy of Sculptra™ Dermal Filler for the Correction of Contour Deformities Caused by Lipoatrophy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00360139
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Nov 30, 2008
- Last update posted
- Aug 20, 2007
Ends 2008
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dermatology Cosmetic Laser Associates of La Jolla | La Jolla | California | 92103 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00360139, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2007 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00360139 live on ClinicalTrials.gov.