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Sculptra Aesthetic for the Treatment of Upper Knee Skin Laxity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487172
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Galderma R&D
Information provided by (Responsible Party):
Goldman, Butterwick, Fitzpatrick and Groff

Study Description
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Brief Summary:
All subjects will receive three, single-sided injections of PLLA, performed 1 month apart.

Condition or disease Intervention/treatment Phase
Lax Skin Knee Device: poly-L-lactic acid to right knee Device: poly-L-lactic acid to left knee Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Upper Knee Skin Laxity
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : April 17, 2019
Actual Study Completion Date : April 17, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Right Side Treated
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
Subjects will receive PLLA injections to the right knee and bacteriostatic water to the left.
Other Name: Sculptra Aesthetic
Left Side Treated
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
Subjects will receive PLLA injections to the left knee and bacteriostatic water to the right.
Other Name: Sculptra Aesthetic


Outcome Measures
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Primary Outcome Measures :
  1. Investigator Assessed Improvement [ Time Frame: Baseline to 6 Months post final treatment ]
    Blinded Investigator Grading


Secondary Outcome Measures :
  1. Subject Assessed Improvement [ Time Frame: Baseline to 6 Months post final treatment ]
    Subject Global Aesthetic Improvement Scale (SGIAS)

  2. Subject Assessed Satisfaction [ Time Frame: Baseline to 6 Months post final treatment ]
    Subject Satisfaction Questionnaire


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487172


Locations
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United States, California
West Dermatology Research Center
San Diego, California, United States, 92121
Sponsors and Collaborators
Goldman, Butterwick, Fitzpatrick and Groff
Galderma R&D
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Goldman, Butterwick, Fitzpatrick and Groff
ClinicalTrials.gov Identifier: NCT03487172    
Other Study ID Numbers: Sculptra Knees
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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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
Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases
 Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs