Status:
COMPLETED
Sculptra Aesthetic for the Treatment of Upper Knee Skin Laxity
Lead Sponsor:
Goldman, Butterwick, Fitzpatrick and Groff
Collaborating Sponsors:
Galderma R&D
Conditions:
Lax Skin
Knee
Eligibility:
FEMALE
30-65 years
Phase:
NA
Brief Summary
All subjects will receive three, single-sided injections of PLLA, performed 1 month apart.
Detailed Description
Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of PLLA, performed 1 month apart. Tre...
Eligibility Criteria
Inclusion
- Healthy women age 30 to 65 years of age.
- Must be willing to give and sign an informed consent form and photographic release form.
- Mild to Severe bilateral skin laxity above the knees (Upper Knee Laxity/Crepiness Grading Scale (Appendix B)
- Must have had a stable body weight for at least 6 months prior to study entry.
- Must be willing to maintain usual sun exposure, diet, and exercise routines for the duration of the study.
- Negative urine pregnancy test results at the time of study entry (if applicable).
- For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation.
- A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
- Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and/or vasectomies of partner with a documented second acceptable method of birth control, should the subject become sexually active.
- Must be willing to comply with study treatments and complete the entire course of the study.
Exclusion
- h. A subject with history of any other skin tightening procedures in the treatment area within the last 12 months. (Microfocused ultrasound, radiofrequency).
- i. A subject with history of bio-stimulatory products or filler injections in the treatment area j. Subjects with scarring in treatment areas. k. A subject with tattoos or permanent implants in the treatment areas. l. A subject with history of or the presence of any skin condition/disease in the treatment area that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis).
- m. A subject with an active bacterial, fungal, or viral infection in the treatment area.
- n. A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- o. A subject planning any other cosmetic procedure to the study treatment area during the study period, other than the treatment that will be performed by the investigator.
- p. Presence of incompletely healed wound in treatment area. q. Non-Ablative laser to the treatment area in the last 3 months. r. A female subject who is pregnant, nursing an infant or planning a pregnancy during the study.
- s. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03487172
Start Date
April 10 2018
End Date
April 17 2019
Last Update
May 3 2019
Active Locations (1)
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1
West Dermatology Research Center
San Diego, California, United States, 92121