Back to resultsSculptra Aesthetic for the Treatment of Upper Knee Skin Laxity
Primary Purpose
Lax Skin, Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
poly-L-lactic acid to right knee
poly-L-lactic acid to left knee
Sponsored by
About this trial
This is an interventional treatment trial for Lax Skin
Eligibility Criteria
Inclusion Criteria:
- 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 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.
Sites / Locations
- West Dermatology Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Right Side Treated
Left Side Treated
Arm Description
Subjects will be randomized to have their right side treated with PLLA and their left side treated with normal saline.
Subjects will be randomized to have their left side treated with PLLA and their right side treated with normal saline.
Outcomes
Primary Outcome Measures
Investigator Assessed Improvement
Blinded Investigator Grading
Secondary Outcome Measures
Subject Assessed Improvement
Subject Global Aesthetic Improvement Scale (SGIAS)
Subject Assessed Satisfaction
Subject Satisfaction Questionnaire
Full Information
NCT ID
NCT03487172
First Posted
March 16, 2018
Last Updated
May 1, 2019
Sponsor
Goldman, Butterwick, Fitzpatrick and Groff
Collaborators
Galderma R&D
1. Study Identification
Unique Protocol Identification Number
NCT03487172
Brief Title
Sculptra Aesthetic for the Treatment of Upper Knee Skin Laxity
Official Title
A Randomized, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Upper Knee Skin Laxity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
April 17, 2019 (Actual)
Study Completion Date
April 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Goldman, Butterwick, Fitzpatrick and Groff
Collaborators
Galderma R&D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lax Skin, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Right Side Treated
Arm Type
Other
Arm Description
Subjects will be randomized to have their right side treated with PLLA and their left side treated with normal saline.
Arm Title
Left Side Treated
Arm Type
Other
Arm Description
Subjects will be randomized to have their left side treated with PLLA and their right side treated with normal saline.
Intervention Type
Device
Intervention Name(s)
poly-L-lactic acid to right knee
Other Intervention Name(s)
Sculptra Aesthetic
Intervention Description
Subjects will receive PLLA injections to the right knee and bacteriostatic water to the left.
Intervention Type
Device
Intervention Name(s)
poly-L-lactic acid to left knee
Other Intervention Name(s)
Sculptra Aesthetic
Intervention Description
Subjects will receive PLLA injections to the left knee and bacteriostatic water to the right.
Primary Outcome Measure Information:
Title
Investigator Assessed Improvement
Description
Blinded Investigator Grading
Time Frame
Baseline to 6 Months post final treatment
Secondary Outcome Measure Information:
Title
Subject Assessed Improvement
Description
Subject Global Aesthetic Improvement Scale (SGIAS)
Time Frame
Baseline to 6 Months post final treatment
Title
Subject Assessed Satisfaction
Description
Subject Satisfaction Questionnaire
Time Frame
Baseline to 6 Months post final treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 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.
Facility Information:
Facility Name
West Dermatology Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sculptra Aesthetic for the Treatment of Upper Knee Skin Laxity
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