LipodystrophyPhase 4NCT00360139
Clinical Trial to Determine the Efficacy of Sculptra™ Dermal Filler for the Correction of Contour Deformities Caused by Lipoatrophy
A Phase 4 study testing Sculptra Injection in people with Lipodystrophy and Emaciation, run by Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipodystrophy, Emaciation
- What is being tested?
- Sculptra Injection
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Show all 14Show fewer
- 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.)
- Subject has ever received an injection or implant of silicone in the area to be treated.
- Subject is currently on any metabolic augmentation medications such as anabolic steroids.
- Current use of anticoagulant therapy or has a history of hemorrhagic disorders.
- History of connective tissue disease or other related disorder that in the investigator's opinion excludes the subject from the study.
- Subject is involved in any other research study involving an investigational product, or has concluded a study less than 30 days ago.
- The subject is suffering from any medical condition or complication that in the investigator's opinion places the subject at risk by participating in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Cosmetic Laser Associates of La Jolla
La Jolla, California, 92103
About this study
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
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.
Read more
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.
Read the 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:
Dermik's 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 0.5±0.7 mm, ranging from 0.0 to 2.1 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 2.2 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.
- Conditions
- Lipodystrophy, Emaciation
- Being tested
- Sculptra Injection
- Keywords
- Sculptra, lipoatrophy, emaciation, facial, dermal filler, poly-L-lactic acid, Dermik, SpaMD, Sanofi, Facial lipoatrophy, Facial emaciation
- Medical subject headings
- Lipodystrophy, Emaciation, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra InjectionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume correction and longevity of correction
Measured: at 12 and 24 months
Secondary outcomes (1)
Safety in non-HIV positive subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2006 (estimated)
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipodystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Mitchel P. Goldman, M.D., Principal investigator, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360139
- Sponsor's protocol ID
- SCLA-SCULP-0305
- Status last verified
- Aug 2007
- First submitted
- 2 Aug 2006
- Last updated
- 21 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00360139
- Acronym / sponsor ID
- SCLA-SCULP-0305
- Conditions
- Lipodystrophy, Emaciation
- Keywords
- Sculptra, lipoatrophy, emaciation, facial, dermal filler, poly-L-lactic acid, Dermik, SpaMD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.University, hospital or other
- Collaborators
- Sanofi
- Study completion
- Dec 2008
- First posted
- 3 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
Dermik's 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 0.5±0.7 mm, ranging from 0.0 to 2.1 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 2.2 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sculptra Injection | Device | – |
Primary outcome
Volume correction and longevity of correction
Time frame: at 12 and 24 months
1 secondary outcome
Safety in non-HIV positive subjects
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2007.
Related trials for Lipodystrophy
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Metabolic Phenotyping in vEDS
Vascular Ehlers-Danlos Syndrome, Vascular Ehlers Danlos Syndrome
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy
RecruitingPhase 3
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Generalized Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchel P. Goldman, M.D. principal investigator
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sculptra Injection in people with Lipodystrophy and Emaciation, run by Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume correction and longevity of correction (time frame: at 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2007.