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 range18 Years
SexALL
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Inclusion criteria
âś“. Bilateral lipoatrophy corresponding to a visual grade 2 or above in the attached lipoatrophy scale.
âś“. Available and willing to attend all follow-up visits.
âś“. Age \> 18 years.
âś“. 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.
âś•. The subject has received a soft tissue augmentation to the area to be treated within the last 6 months.
âś•. Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study.
âś•. The subject has received autologous fat transfer in the last 6 months.
âś•. Subject is suffering from facial Kaposi's sarcoma.
âś•. The subject has active skin diseases or inflammation on or near the area of injection, such as psoriasis, herpes zoster, infection, or discoid lupus.
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.
âś•. 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.)