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Sculptra Aesthetic Post-Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02425943
Recruitment Status : Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Brief Summary:

Study is designed to

  1. to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of wrinkle assessment score (WAS) 2 to 4 nasolabial fold (NLF) contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.
  2. to evaluate the time to onset, duration, severity, relationship to Sculptra Aesthetic and/or injection procedure, and outcome of all adverse events during the course of the study, by Fitzpatrick skin type.
  3. to evaluate the change in the WAS from baseline to post-treatment follow-up time points at Months 6, 13, and Years 2, 3, 4, and 5 in NLFs and other facial wrinkles.
  4. to evaluate Investigator/subject global assessments at Months 6, 13, and Years 2, 3, 4, and 5.

Condition or disease Intervention/treatment Phase
Nasolabial Fold Contour Deficiencies Wrinkles Device: injectable poly-L-lactic acid Sculptra Aesthetic Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 863 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label, Multicenter Study to Evaluate the Long-Term Safety of Sculptra®Aesthetic in Immuno-Competent Subjects Stratified by Fitzpatrick Skin Type I-VI)
Study Start Date : May 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Sculptra Aesthetic Device: injectable poly-L-lactic acid Sculptra Aesthetic
Other Name: Sculptra Aesthetic




Primary Outcome Measures :
  1. Incidence rate of subjects with any injection site nodule and/or papule [ Time Frame: 5 years ]
    Incidence rate of subjects with any injection site nodule and/or papule

  2. Incidence rate of subjects with injection site adverse events of interest [ Time Frame: 5 years ]
    Incidence rate of subjects with injection site adverse events of interest (other than injection site nodule and/or papule)


Secondary Outcome Measures :
  1. Incidence rate of subjects with any injection site nodule and/or papule [ Time Frame: 2 years ]
    Incidence rate of subjects with any injection site nodule and/or papule

  2. Incidence rate of subjects with injection site adverse events of interest [ Time Frame: 2 years ]
    Incidence rate of subjects with injection site adverse events of interest (other than injection site nodule and/or papule)

  3. Change from baseline to post-treatment follow-up time points in the Wrinkle Assessment Score (WAS) [ Time Frame: up to 5 years ]
    Change from baseline to post-treatment follow-up time points in the WAS at Month 6, Month 13, and Years 2, 3, 4, and 5

  4. Global Assessment Score [ Time Frame: up to 5 years ]
    Investigator/Subject Global Assessments Scores at Month 6, Month 13, and Years 2, 3, 4, and 5.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects seeking correction of shallow to deep NLF contour deficiencies. Subjects must have a score of ≥2 and ≤4 on the photo-numeric wrinkle assessment scale of both the right and left NLFs at entry.

    - Subjects may also have other facial wrinkles (ie, cheek lines, marionette lines, and chin crease/chin fold) using the Assessment Scale for Other Facial Wrinkles for which deep dermal grid pattern (cross-hatch) injection technique is appropriate.

  2. Subjects must sign a statement of informed consent; initial and date "A Patient's Guide to Treatment with Sculptra® Aesthetic"; and sign and date the "Health Insurance Portability and Accountability Act (HIPAA) Authorization".

Exclusion Criteria:

  1. Subjects seeking, at entry into the study, correction of other facial wrinkles with Sculptra Aesthetic in the following anatomical sites/lines: horizontal forehead lines, glabellar frown lines, periorbital lines, periauricular lines, upper lip lines, lower lip lines, corner of the mouth lines and/or horizontal neck folds.
  2. Subjects that are less than 18 or greater than 75 years of age.
  3. Subjects with a score of 0, 1, or 5 on the photo-numeric wrinkle assessment scale of either the right or left NLFs.
  4. Personal history of allergic/anaphylactic reactions including hypersensitivity to local anesthetics (eg, lidocaine, etc), latex, or any of the Sculptra Aesthetic constituents.
  5. History of facial skin cancer or recurrence of facial skin cancer other than basal cell carcinoma within 5 years.
  6. Known history of keloids or bleeding/coagulation disorder.
  7. History of human immunodeficiency virus, diabetes, connective tissue disorders (eg, lupus, scleroderma), or other serious systemic disease (eg, sarcoidosis).
  8. Presence of surgical or non-surgical scars in the area to be treated.
  9. Active inflammatory process or infection in the area to be treated (skin eruptions such as cysts, pimples, rashes, herpes simplex, herpes zoster, cancerous/precancerous lesions), or any other active or serious skin disease (eg, eczema, psoriasis of the face, severe rosacea, severe acne, etc.).
  10. Subjects with an American Society of Anesthesiologists' Physical Status Classification System Score of ≥P3 (P3 = a subject with severe systemic disease).
  11. Subjects with medical conditions that might require the use of immunosuppressive (except for oral steroids that can be used for less than 1 month over the duration of the study) or anti-inflammatory medications during the trial (eg, severe asthma, rheumatoid arthritis, etc).
  12. Viral, chemical, or any active hepatitis within the past year.
  13. Planned surgical procedures with incisions and suturing in the area to be treated during the course of the study.
  14. Planned major facial aesthetic procedure/plastic surgery (eg, rhinoplasty [with or without implant], facelift, congenital defect repair, etc) during the course of the study.
  15. Subjects who have or plan to use exclusionary treatments/medications/ devices, as described in the protocol.
  16. Women who are pregnant, nursing or intend to become pregnant over the duration of the study or women who are of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
  17. Subjects who are unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the clinical trial protocol.
  18. Subjects who have received any experimental drug or device within the previous 3 months prior to first treatment.
  19. Subjects who are known alcohol or drug abusers.
  20. Subjects who are suffering from any psychological condition, or are under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s) may constitute an unwarranted risk or which may affect the subjects' compliance or adherence to study procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425943


Locations
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United States, Florida
Rendon Center
Boca Raton, Florida, United States
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
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Study Chair: Ted Wagner Galderma
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Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT02425943    
Other Study ID Numbers: GLI.04.SPR.US10321
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs