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Clinical Trial to Determine the Efficacy of Sculptra™ Dermal Filler for the Correction of Contour Deformities Caused by Lipoatrophy

NCT00360139 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2007-08-21

No results posted yet for this study

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.

Conditions

  • Lipodystrophy
  • Emaciation

Interventions

DEVICE

Sculptra Injection

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

    lead OTHER

Principal Investigators

  • Mitchel P. Goldman, M.D. · Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00360139 on ClinicalTrials.gov