Sculptra Aesthetic Post-Approval Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/19/2018 |
| Start Date: | May 2015 |
| End Date: | June 2021 |
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 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.
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.
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.
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