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

NCT00360139 | Withdrawn Phase 4

• 1 other identifier: SCLA-SCULP-0305
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipodystrophy; Emaciation

Keywords

Sculptra; lipoatrophy; emaciation; facial; dermal filler; poly-L-lactic acid; Dermik; SpaMD; Sanofi; Facial lipoatrophy; Facial emaciation

Outcome Measures

Primary Outcomes (1)

• Volume correction and longevity of correction

  at 12 and 24 months

Secondary Outcomes (1)

• Safety in non-HIV positive subjects

Interventions

Sculptra Injection DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.: lead
• Sanofi: collaborator

Study Sites (1)

Dermatology Cosmetic Laser Associates of La Jolla

La Jolla, California, 92103, United States

Location

MeSH Terms

Conditions

Lipodystrophy; Emaciation; Facies

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Thinness; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Mitchel P. Goldman, M.D.

  Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 2, 2006
• First Posted: August 3, 2006
• Study Completion: December 1, 2008
• Last Updated: August 21, 2007

Record last verified: 2007-08

Locations

US (1)