Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360139
Status:
WITHDRAWN
Last Update Posted:
2007-08-21
First Post:
2006-08-02
Brief Title:
Clinical Trial to Determine the Efficacy of Sculptra Dermal Filler for the Correction of Contour Deformities Caused by Lipoatrophy
Sponsor:
Dermatology Cosmetic Laser Medical Associates of La Jolla Inc
Organization:
Dermatology Cosmetic Laser Medical Associates of La Jolla Inc
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 photographictopographical 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
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 photographictopographical 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
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 dermal atrophy in both the HIV and non-HIV populations Almost all clinical trials have used a visual assessment scale to grade correction as well as persistence Recently dermal ultrasound has been used to provide an objective measurement of dermal thickening but the ultrasound procedure measures only a fraction of the dermis and is subject to a high degree of variability because of the difficulty in measuring the same area Our protocol utilizes the Primos ½ face system to produce a 3-dimensional evaluation of a large area This will produce excellent reproducible results as well as outstanding photographs for patient demonstration
Sculptra is an injectable implant that contains microparticles or poly-L-lactic acid a biocompatible biodegradable synthetic polymer from the alpha-hydroxy-acid family Sculptra is reconstituted prior to use by the addition of sterile water for injection USP SWFI to form a sterile non-pyrogenic suspension
Comparison
Dermiks Vega Study - The Vega study was a 96-week open-label uncontrolled single-center study to determine the treatment effects of Sculptra on the signs of lipoatrophy of the face in 50 patients infected with human immunodeficiency virus Patients had a mean age of 45 years range 33-58 84 were Caucasian and 98 were male All patients had little or no adipose tissue in cheek area at baseline indicating severe facial lipoatrophy mean adipose thickness of 0507 mm ranging from 00 to 21 mm
Treatment injection sessions were conducted at approximately two-week intervals and the majority 86 of the patients received four to five injection sessions Generally one vial of product was injected intradermally into multiple points of each cheek at each injection session The quantity of injected product and number of injection sessions depended upon the severity of the facial depression
All patients experienced increases in skin thickness in the treatment area minimum increase of 22 mm noted at Week 8 visit Statistically significant increases above baseline values of mean skin thickness were noted at all time points Weeks 8 24 48 72 and 96 during the study Increases in mean skin thickness changes above baseline persisted for up to 2 years
This study follows the same general design as the Vega study
Sculptra has been used to correct dermal atrophy in both the HIV and non-HIV populations Almost all clinical trials have used a visual assessment scale to grade correction as well as persistence Recently dermal ultrasound has been used to provide an objective measurement of dermal thickening but the ultrasound procedure measures only a fraction of the dermis and is subject to a high degree of variability because of the difficulty in measuring the same area Our protocol utilizes the Primos ½ face system to produce a 3-dimensional evaluation of a large area This will produce excellent reproducible results as well as outstanding photographs for patient demonstration
Sculptra is an injectable implant that contains microparticles or poly-L-lactic acid a biocompatible biodegradable synthetic polymer from the alpha-hydroxy-acid family Sculptra is reconstituted prior to use by the addition of sterile water for injection USP SWFI to form a sterile non-pyrogenic suspension
Comparison
Dermiks Vega Study - The Vega study was a 96-week open-label uncontrolled single-center study to determine the treatment effects of Sculptra on the signs of lipoatrophy of the face in 50 patients infected with human immunodeficiency virus Patients had a mean age of 45 years range 33-58 84 were Caucasian and 98 were male All patients had little or no adipose tissue in cheek area at baseline indicating severe facial lipoatrophy mean adipose thickness of 0507 mm ranging from 00 to 21 mm
Treatment injection sessions were conducted at approximately two-week intervals and the majority 86 of the patients received four to five injection sessions Generally one vial of product was injected intradermally into multiple points of each cheek at each injection session The quantity of injected product and number of injection sessions depended upon the severity of the facial depression
All patients experienced increases in skin thickness in the treatment area minimum increase of 22 mm noted at Week 8 visit Statistically significant increases above baseline values of mean skin thickness were noted at all time points Weeks 8 24 48 72 and 96 during the study Increases in mean skin thickness changes above baseline persisted for up to 2 years
This study follows the same general design as the Vega study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None