Lax SkinNCT03487172
Sculptra Aesthetic for the Treatment of Upper Knee Skin Laxity
A study testing poly-L-lactic acid to right knee and poly-L-lactic acid to left knee in people with Lax Skin and Knee, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
All subjects will receive three, single-sided injections of PLLA, performed 1 month apart. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- What is being tested?
- poly-L-lactic acid to right knee and poly-L-lactic acid to left knee
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2018to 17 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- A subject with history of any other skin tightening procedures in the treatment area within the last 12 months. (Microfocused ultrasound, radiofrequency).
- 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).
- A subject with an active bacterial, fungal, or viral infection in the treatment area.
- 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.
- 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.
- 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.
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Dermatology Research Center
San Diego, California, 92121
About this study
Official title: A Randomized, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Upper Knee Skin Laxity
All subjects will receive three, single-sided injections of PLLA, performed 1 month apart.
Read the 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.
- Being tested
- poly-L-lactic acid to right knee, poly-L-lactic acid to left knee
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
poly-L-lactic acid to right kneeDevice
Also called Sculptra Aesthetic
Subjects will receive PLLA injections to the right knee and bacteriostatic water to the left.
poly-L-lactic acid to left kneeDevice
Also called Sculptra Aesthetic
Subjects will receive PLLA injections to the left knee and bacteriostatic water to the right.
| Study group | Role | What they receive |
|---|---|---|
| Right Side Treated | Other | Subjects will be randomized to have their right side treated with PLLA and their left side treated with normal saline. Receives: 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. Receives: Device: poly-L-lactic acid to left knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Assessed Improvement
Blinded Investigator Grading
Measured: Baseline to 6 Months post final treatment
Secondary outcomes (2)
Subject Assessed Improvement
Subject Global Aesthetic Improvement Scale (SGIAS)
Measured: Baseline to 6 Months post final treatment
Subject Assessed Satisfaction
Subject Satisfaction Questionnaire
Measured: Baseline to 6 Months post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start10 Apr 2018
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lax SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487172
- Sponsor's protocol ID
- Sculptra Knees
- Status last verified
- May 2019
- First submitted
- 16 Mar 2018
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Upper Knee Skin Laxity
- ClinicalTrials.gov ID
- NCT03487172
- Acronym / sponsor ID
- Sculptra Knees
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Right Side Treated | Other | Device: poly-L-lactic acid to right kneeSubjects will be randomized to have their right side treated with PLLA and their left side treated with normal saline. |
| Left Side Treated | Other | Device: poly-L-lactic acid to left kneeSubjects will be randomized to have their left side treated with PLLA and their right side treated with normal saline. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- A subject with history of any other skin tightening procedures in the treatment area within the last 12 months. (Microfocused ultrasound, radiofrequency).
- 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).
- A subject with an active bacterial, fungal, or viral infection in the treatment area.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| poly-L-lactic acid to right kneeAlso: Sculptra AestheticSubjects will receive PLLA injections to the right knee and bacteriostatic water to the left. | Device | Right Side Treated |
| poly-L-lactic acid to left kneeAlso: Sculptra AestheticSubjects will receive PLLA injections to the left knee and bacteriostatic water to the right. | Device | Left Side Treated |
Primary outcome
Investigator Assessed Improvement
Time frame: Baseline to 6 Months post final treatment
Blinded Investigator Grading
2 secondary outcomes
Subject Assessed Improvement
Time frame: Baseline to 6 Months post final treatment
Subject Assessed Satisfaction
Time frame: Baseline to 6 Months post final treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing poly-L-lactic acid to right knee and poly-L-lactic acid to left knee in people with Lax Skin and Knee, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Assessed Improvement (time frame: Baseline to 6 Months post final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.