Skin LaxityNCT05445661
Sculptra to Aid in Treatment of Arm Laxity
A study testing injectable poly-L-lactic acid and Normal Saline in people with Skin Laxity, run by Goldman, Butterwick, Fitzpatrick and Groff.
Trial summary
To assess the safety, efficacy, and patient satisfaction associated with the treatment of upper inner arm crepiness/laxity with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX). Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- injectable poly-L-lactic acid and Normal Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2022to 20 Sep 2023
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult females aged 40 to 70 years
- Subjects in good general health based on investigator's judgment and medical history
- Upper inner arm crepiness/laxity that improves when the skin of the upper inner arm is stretched or lifted superiorly
- Moderate to severe upper inner arm skin crepiness/laxity based on the Upper Inner Arm Visual Crepiness/Laxity Grading Scale (Appendix B)
- Must be willing to give and sign an informed consent form and photographic release form
- Must have a stable body weight for at least six (6) months prior to study entry
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- Must be willing to maintain usual sun exposure, diet, and exercise routines for the duration of the study
- Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study
- Negative urine pregnancy test result 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.
- 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 vasectomy 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
- Liposuction to bilateral upper arms during the 12-month period prior to study treatment or any time during the course of the study
- Mesotherapy; dermal fillers, biostimulatory injectables; radiofrequency device treatments; microfocused ultrasound device treatments; laser and light-based device treatments; microneedling; cryolipolysis; high intensity focused electromagnetic energy device treatment; or surgery (i.e., brachyplasty) during the 12-month period before study treatment
- Any investigational treatment of skin crepiness/laxity of the upper arms during the 12-month period before the study treatment
- Massage therapy during the 3-month period before study treatment.
- Creams/cosmeceuticals and/or home therapies to prevent or treat skin laxity during the four-week period before study treatment
- Subjects with scarring in the treatment areas
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- History of thrombosis, post-thrombosis syndrome, or any vascular disorder of the bilateral upper extremities
- Any history of bleeding or coagulation disorders
- Subjects with tattoos or permanent implants in the treatment areas
- Subjects 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
- Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
- Subjects with an active bacterial, viral, or fungal infection of the treatment areas
- Subjects who spray tanned or used sunless tanners in the treatment areas four (4) weeks prior to study treatment
- History of lidocaine sensitivity deemed by the investigator to preclude the subject from enrolling into the study
- Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator
- Presence of incompletely healed wound(s) in the treatment area
- Subject who is on an immunosuppressant or has an autoimmune condition
- Female subjects who are pregnant, planning a pregnancy, or breast feeding 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
No sites are listed yet.
About this study
Official title: A Single Center, Double-Blinded, Split-Body, Randomized Clinical Trial of Injectable Poly-L-Lactic Acid for the Treatment of Upper Inner Arm Skin Crepiness/Laxity
To assess the safety, efficacy, and patient satisfaction associated with the treatment of upper inner arm crepiness/laxity with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX).
Read the detailed description
The primary objective of this clinical trial is to assess the safety, efficacy, and patient satisfaction associated with the treatment of upper inner arm crepiness/laxity with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX).
Enrolled subjects will be randomized to two (2) treatment groups: "right upper medial inner arm treated" and "left upper medial inner arm treated". All subjects will receive three (3), single-sided injections of Sculptra® Aesthetic (Galderma Laboratories; Fort Worth, TX), performed one (1) month ± 7 days apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic saline, injected in the same manner as Sculptra® Aesthetic. One (1) vial of Sculptra® Aesthetic, diluted to 16mL, will be used per treatment session.
Subjects satisfying all inclusion and no exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory digital photography with overhead lighting and VECTRA® (Canfield Scientific, Inc.; Parsippany, NJ) 3D body photography will be obtained of each subject's treatment area. In order to participate in the study, subjects must provide written informed consent to have their photographs used for research, publication, and/or commercial purposes.
- Conditions
- Skin Laxity
- Being tested
- injectable poly-L-lactic acid, Normal Saline
- Keywords
- Skin, Volume, Volume Loss, Arms, Cosmetic
- Medical subject headings
- Cutis Laxa, Rhabdomyosarcoma, Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable poly-L-lactic acidDevice
Also called PLLA, Sculptra, Sculptra Aesthetic, Galderma
Injectable biostimulant for volume loss
Normal SalineOther
Sham Comparator
| Study group | Role | What they receive |
|---|---|---|
| Injectable poly-L-lactic acid | Experimental | One of the subject's arms will be treated with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX). Receives: Device: injectable poly-L-lactic acid |
| Normal Saline | Sham comparator | One of the subject's arms will be treated with injectable normal saline Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Inner Arm Visual Skin Crepiness/Laxity Grading Scale by blinded investigator will be done to assess change.
Blinded Investigator will grade subjects arms at different time points using the following grading scale:
0 None No loose skin, toned and firm skin with smooth skin surface texture
1 Mild Mildly loose skin, somewhat toned with smooth skin surface texture
2 Moderate Moderately loose skin, no deep tone, few wrinkles, and crepiness on skin surface
3 Severe Very loose skin without underlying tone, multiple wrinkles and crepiness on skin surface, skin distinct from underlying subcutaneous tissue via palpation
4 Extreme Prominent redundancy of skin without underlying tone, severe wrinkling, and crepiness on skin surface
Measured: Baseline, Day 90, Day 150, Day 240, Day 330
Point of Maximal Upper Arm Skin Laxity and Circumference Measurements by blinded investigator done to assess change.
Blinded Investigator will take measurements of subjects arms at different time points using the following guidelines:
Blinded Investigator Measurement of Point of Maximal Upper Arm Skin Laxity and Circumference:
Length of Upper Arm from Axilla to Olecranon Process of Ulna Left Upper Arm Right Upper Arm cm cm
Horizontal Distance from Axilla of Point of Maximal Upper Arm Skin Laxity Left Upper Arm Right Upper Arm cm cm
Vertical Diameter Measured from Point of Maximal Upper Arm Laxity Left Upper Arm Right Upper Arm cm cm
Upper Arm Circumference Measured from Point of Maximal Skin Laxity Left Upper Arm Right Upper Arm cm cm
Measured: Baseline, Day 90, Day 150, Day 240, Day 330
Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator
Blinded Physician Global Aesthetic Improvement Scale Assessment (PGAIS) Rating Description
- Very Much Improved: Optimal cosmetic result in this subject.
- Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject.
- Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated.
- No Change: The appearance is essentially the same as the original condition.
- Worse: The appearance is worse than the original condition.
Scores write a number under each treated area or check Not Treated Left Upper Inner Arm Right Upper Inner Arm
Not Treated Not Treated
Measured: Day 90, Day 150, Day 240, Day 330
Blinded Identification of Correct Treatment Area Photographic Assessment by blinded investigator
The baseline (Day 0) and 9 month (Day 330) photographs will be randomly put side-by-side and labeled either (A) or (B). The blinded investigator will then fill out the following:
- Do you see an improvement in the appearance of the crepiness/laxity of the upper inner arm between the two sets of photos? (Yes / No)
- If yes to question #1:
- Which is the post-treatment photograph? (A / B)
- Which is the treatment side? (Right / Left)
Measured: Day 330
Secondary outcomes (3)
Subject Global Aesthetic Improvement Scale (SGIAS)
Subject Global Aesthetic Improvement Scale Assessment (SGAIS) How would you rate the change in appearance of your treated areas? Non-treated areas will be checked as "Not Treated" for you.
Rating Description
- Very Much Improved: Optimal cosmetic result
- Much Improved: Marked improvement in appearance form the initial condition, but not completely optimal
- Improved: Obvious improvement in appearance from initial condition
- No Change: The appearance is essentially the same as the original condition
- Worse: The appearance is worse than the original condition
Scores (write a number to rate each treated area) Left Upper Inner Arm Right Upper Inner Arm
Not Treated Not Treated
Measured: Day 90, Day 150, Day 240, Day 330
Subject Satisfaction Questionnaire
Subject Satisfaction Questionnaire How would you rate your satisfaction of each treated area? Non-treated areas will be checked as "Not Treated" for you.
Rating Description 0 Not satisfied
- Somewhat satisfied
- Satisfied
- Very satisfied
- Extremely Satisfied
Scores (write a number to rate each treated area) Left Upper Inner Arm Right Upper Inner Arm
Not Treated Not Treated
Measured: Day 90, Day 150, Day 240, Day 330
Evaluation of side effects and adverse effects will be completed by the investigators.
Treating Investigator Evaluation of Side Effects Rating Description 0 NONE: Normal
- TRACE: Barely visible and localized
- MILD: Somewhat visible and diffuse
- MODERATE: Visible and diffuse
- SEVERE: Extremely visible and dense
SCORES (write number under each treated area or check "Not Treated") Erythema Left Upper Inner Arm Right Upper Inner Arm
Not Treated Not Treated
Edema Left Upper Inner Arm Right Upper Inner Arm
Not Treated Not Treated
Contour Irregularity Left Upper Inner Arm Right Upper Inner Arm
Not Treated Not Treated
Nodules Left Upper Inner Arm Right Upper Inner Arm
Not Treated Not Treated
Measured: Baseline, Day 30, Day 60, Day 90, Day 150, Day 240, Day 330
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start20 Jul 2022 (estimated)
- Primary completion20 Sep 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies 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
- This is a prospective, single-site, double-blinded, split-body, randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
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
- NCT05445661
- Sponsor's protocol ID
- Sculptra-Arms-2022-02
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Double-Blinded, Split-Body, Randomized Clinical Trial of Injectable Poly-L-Lactic Acid for the Treatment of Upper Inner Arm Skin Crepiness/Laxity
- ClinicalTrials.gov ID
- NCT05445661
- Acronym / sponsor ID
- Sculptra-Arms-2022-02
- Conditions
- Skin Laxity
- Keywords
- Skin, Volume, Volume Loss, Arms, Cosmetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 20 Jul 2022 (estimated)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 6 Jul 2022 (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.
To assess the safety, efficacy, and patient satisfaction associated with the treatment of upper inner arm crepiness/laxity with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX).
Detailed description
The primary objective of this clinical trial is to assess the safety, efficacy, and patient satisfaction associated with the treatment of upper inner arm crepiness/laxity with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX).
Enrolled subjects will be randomized to two (2) treatment groups: "right upper medial inner arm treated" and "left upper medial inner arm treated". All subjects will receive three (3), single-sided injections of Sculptra® Aesthetic (Galderma Laboratories; Fort Worth, TX), performed one (1) month ± 7 days apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic saline, injected in the same manner as Sculptra® Aesthetic. One (1) vial of Sculptra® Aesthetic, diluted to 16mL, will be used per treatment session.
Subjects satisfying all inclusion and no exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory digital photography with overhead lighting and VECTRA® (Canfield Scientific, Inc.; Parsippany, NJ) 3D body photography will be obtained of each subject's treatment area. In order to participate in the study, subjects must provide written informed consent to have their photographs used for research, publication, and/or commercial purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, single-site, double-blinded, split-body, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Injectable poly-L-lactic acid | Experimental | Device: injectable poly-L-lactic acidOne of the subject's arms will be treated with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX). |
| Normal Saline | Sham comparator | Other: Normal SalineOne of the subject's arms will be treated with injectable normal saline |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult females aged 40 to 70 years
- Subjects in good general health based on investigator's judgment and medical history
- Upper inner arm crepiness/laxity that improves when the skin of the upper inner arm is stretched or lifted superiorly
- Moderate to severe upper inner arm skin crepiness/laxity based on the Upper Inner Arm Visual Crepiness/Laxity Grading Scale (Appendix B)
- Must be willing to give and sign an informed consent form and photographic release form
Key exclusion criteria (19 listed)
- Liposuction to bilateral upper arms during the 12-month period prior to study treatment or any time during the course of the study
- Mesotherapy; dermal fillers, biostimulatory injectables; radiofrequency device treatments; microfocused ultrasound device treatments; laser and light-based device treatments; microneedling; cryolipolysis; high intensity focused electromagnetic energy device treatment; or surgery (i.e., brachyplasty) during the 12-month period before study treatment
- Any investigational treatment of skin crepiness/laxity of the upper arms during the 12-month period before the study treatment
- Massage therapy during the 3-month period before study treatment.
- Creams/cosmeceuticals and/or home therapies to prevent or treat skin laxity during the four-week period before study treatment
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 |
|---|---|---|
| injectable poly-L-lactic acidAlso: PLLA, Sculptra, Sculptra Aesthetic, GaldermaInjectable biostimulant for volume loss | Device | Injectable poly-L-lactic acid |
| Normal SalineSham Comparator | Other | Normal Saline |
Primary outcome
Upper Inner Arm Visual Skin Crepiness/Laxity Grading Scale by blinded investigator will be done to assess change.
Time frame: Baseline, Day 90, Day 150, Day 240, Day 330
Blinded Investigator will grade subjects arms at different time points using the following grading scale: 0 None No loose skin, toned and firm skin with smooth skin surface texture 1 Mild Mildly loose skin, somewhat toned with smooth skin surface texture 2 Moderate Moderately loose skin, no deep tone, few wrinkles, and crepiness on skin surface 3 Severe Very loose skin without underlying tone, multiple wrinkles and crepiness on skin surface, skin distinct from underlying subcutaneous tissue via palpation 4 Extreme Prominent redundancy of skin without underlying tone, severe wrinkling, and crepiness on skin surface
Point of Maximal Upper Arm Skin Laxity and Circumference Measurements by blinded investigator done to assess change.
Time frame: Baseline, Day 90, Day 150, Day 240, Day 330
Blinded Investigator will take measurements of subjects arms at different time points using the following guidelines: Blinded Investigator Measurement of Point of Maximal Upper Arm Skin Laxity and Circumference: Length of Upper Arm from Axilla to Olecranon Process of Ulna Left Upper Arm Right Upper Arm cm cm Horizontal Distance from Axilla of Point of Maximal Upper Arm Skin Laxity Left Upper Arm Right Upper Arm cm cm Vertical Diameter Measured from Point of Maximal Upper Arm Laxity Left Upper Arm Right Upper Arm cm cm Upper Arm Circumference Measured from Point of Maximal Skin Laxity Left Upper Arm Right Upper Arm cm cm
Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator
Time frame: Day 90, Day 150, Day 240, Day 330
Blinded Physician Global Aesthetic Improvement Scale Assessment (PGAIS) Rating Description 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition. Scores write a number under each treated area or check Not Treated Left Upper Inner Arm Right Upper Inner Arm Not Treated Not Treated
Blinded Identification of Correct Treatment Area Photographic Assessment by blinded investigator
Time frame: Day 330
The baseline (Day 0) and 9 month (Day 330) photographs will be randomly put side-by-side and labeled either (A) or (B). The blinded investigator will then fill out the following: 1. Do you see an improvement in the appearance of the crepiness/laxity of the upper inner arm between the two sets of photos? (Yes / No) 2. If yes to question #1: 1. Which is the post-treatment photograph? (A / B) 2. Which is the treatment side? (Right / Left)
3 secondary outcomes
Subject Global Aesthetic Improvement Scale (SGIAS)
Time frame: Day 90, Day 150, Day 240, Day 330
Subject Satisfaction Questionnaire
Time frame: Day 90, Day 150, Day 240, Day 330
Evaluation of side effects and adverse effects will be completed by the investigators.
Time frame: Baseline, Day 30, Day 60, Day 90, Day 150, Day 240, Day 330
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing injectable poly-L-lactic acid and Normal Saline in people with Skin Laxity, run by Goldman, Butterwick, Fitzpatrick and Groff.
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 13 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pacheco (8586571004, apacheco@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Inner Arm Visual Skin Crepiness/Laxity Grading Scale by blinded investigator will be done to assess change. (time frame: Baseline, Day 90, Day 150, Day 240, Day 330). The study lists 4 primary outcomes in all. 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 6 Jul 2022.