Knee, Lax Skin
Conditions
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. 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. Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory photography using 2D photography and Vectra will be obtained of each subject's treatment area. All photographs may be used for research and/or commercial use.
Interventions
DEVICEpoly-L-lactic acid to right knee
Subjects will receive PLLA injections to the right knee and bacteriostatic water to the left.
DEVICEpoly-L-lactic acid to left knee
Subjects will receive PLLA injections to the left knee and bacteriostatic water to the right.
Sponsors
Galderma R&D
Goldman, Butterwick, Fitzpatrick and Groff
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model 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. 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
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy women age 30 to 65 years of age. 2. Must be willing to give and sign an informed consent form and photographic release form. 3. Mild to Severe bilateral skin laxity above the knees (Upper Knee Laxity/Crepiness Grading Scale (Appendix B) 4. Must have had a stable body weight for at least 6 months prior to study entry. 5. Must be willing to maintain usual sun exposure, diet, and exercise routines for the duration of the study. 6. Negative urine pregnancy test results at the time of study entry (if applicable). 7. 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. 1. 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. 2. 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. 8. Must be willing to comply with study treatments and complete the entire course of the study.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Assessed Improvement | Baseline to 6 Months post final treatment | Blinded Investigator Grading |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Assessed Improvement | Baseline to 6 Months post final treatment | Subject Global Aesthetic Improvement Scale (SGIAS) |
| Subject Assessed Satisfaction | Baseline to 6 Months post final treatment | Subject Satisfaction Questionnaire |
Countries
United States
Outcome results
None listed