Sculptra Aesthetic for the Treatment of Upper Knee Skin Laxity

NCT03487172 | Completed FDA Device

• 1 other identifier: Sculptra Knees
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

All subjects will receive three, single-sided injections of PLLA, performed 1 month apart.

Conditions

Lax Skin; Knee

Outcome Measures

Primary Outcomes (1)

• Investigator Assessed Improvement

  Blinded Investigator Grading

  Baseline to 6 Months post final treatment

Secondary Outcomes (2)

• Subject Assessed Improvement

  Baseline to 6 Months post final treatment

• Subject Assessed Satisfaction

  Baseline to 6 Months post final treatment

Study Arms (2)

Right Side Treated

OTHER

Subjects will be randomized to have their right side treated with PLLA and their left side treated with normal saline.

Device: poly-L-lactic acid to right knee

Left Side Treated

OTHER

Subjects will be randomized to have their left side treated with PLLA and their right side treated with normal saline.

Device: poly-L-lactic acid to left knee

Interventions

poly-L-lactic acid to right knee DEVICE

Subjects will receive PLLA injections to the right knee and bacteriostatic water to the left.

Also known as: Sculptra Aesthetic

Right Side Treated

poly-L-lactic acid to left knee DEVICE

Subjects will receive PLLA injections to the left knee and bacteriostatic water to the right.

Also known as: Sculptra Aesthetic

Left Side Treated

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• Galderma R&D: collaborator

Study Sites (1)

West Dermatology Research Center

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. Treatments will be provided to one randomly assigned knee. The non-treatment knee will receive bacteriostatic water, injected in the same manner as PLLA. Up to one (1) syringe of PLLA, diluted at 16 mL, will be used per session

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: April 3, 2018
• Study Start: April 10, 2018
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: May 3, 2019

Record last verified: 2019-05

Locations

US (1)