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

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Brief Title

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

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

      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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

Volume correction and longevity of correction

Secondary Outcome

 Safety in non-HIV positive subjects

Condition

Lipodystrophy

Intervention

Sculptra Injection


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

15


Completion Date

December 2008


Eligibility Criteria

        Inclusion Criteria:

          1. Bilateral lipoatrophy corresponding to a visual grade 2 or above in the attached
             lipoatrophy scale.

          2. Available and willing to attend all follow-up visits.

          3. Age > 18 years.

          4. Able and willing to give informed consent.

        Exclusion Criteria:

          1. Known allergy or sensitivity to Sculptra™, suture material or any material that in the
             investigator's opinion may cause an allergic reaction.

          2. The subject has received a soft tissue augmentation to the area to be treated within
             the last 6 months.

          3. Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of
             the study.

          4. The subject has received autologous fat transfer in the last 6 months.

          5. Subject is suffering from facial Kaposi's sarcoma.

          6. The subject has active skin diseases or inflammation on or near the area of injection,
             such as psoriasis, herpes zoster, infection, or discoid lupus.

          7. History of sensitivity to lidocaine.

          8. 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.)

          9. Subject has ever received an injection or implant of silicone in the area to be
             treated.

         10. Subject is currently on any metabolic augmentation medications such as anabolic
             steroids.

         11. Current use of anticoagulant therapy or has a history of hemorrhagic disorders.

         12. History of connective tissue disease or other related disorder that in the
             investigator's opinion excludes the subject from the study.

         13. Subject is involved in any other research study involving an investigational product,
             or has concluded a study less than 30 days ago.

         14. 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mitchel P. Goldman, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00360139

Organization ID

SCLA-SCULP-0305



Study Sponsor

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

Collaborators

 Sanofi

Study Sponsor

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


Verification Date

August 2007