Back to resultsSculptra to Aid in Treatment of Arm Laxity
Primary Purpose
Skin Laxity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
injectable poly-L-lactic acid
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity focused on measuring Skin, Volume, Volume Loss, Arms, Cosmetic
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Injectable poly-L-lactic acid
Normal Saline
Arm Description
One of the subject's arms will be treated with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX).
One of the subject's arms will be treated with injectable normal saline
Outcomes
Primary Outcome Measures
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
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
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
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)
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT05445661
First Posted
June 10, 2022
Last Updated
June 30, 2022
Sponsor
Goldman, Butterwick, Fitzpatrick and Groff
Collaborators
Galderma R&D
1. Study Identification
Unique Protocol Identification Number
NCT05445661
Brief Title
Sculptra to Aid in Treatment of Arm Laxity
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 20, 2022 (Anticipated)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
September 20, 2023 (Anticipated)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
Keywords
Skin, Volume, Volume Loss, Arms, Cosmetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, single-site, double-blinded, split-body, randomized controlled trial.
Masking
ParticipantOutcomes Assessor
Masking Description
Subject and Outcome Assessor will be unaware of which side of the subject is treated with the study device and which is treated with saline.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Injectable poly-L-lactic acid
Arm Type
Experimental
Arm Description
One of the subject's arms will be treated with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX).
Arm Title
Normal Saline
Arm Type
Sham Comparator
Arm Description
One of the subject's arms will be treated with injectable normal saline
Intervention Type
Device
Intervention Name(s)
injectable poly-L-lactic acid
Other Intervention Name(s)
PLLA, Sculptra, Sculptra Aesthetic, Galderma
Intervention Description
Injectable biostimulant for volume loss
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
Sham Comparator
Primary Outcome Measure Information:
Title
Upper Inner Arm Visual Skin Crepiness/Laxity Grading Scale by blinded investigator will be done to assess change.
Description
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
Time Frame
Baseline, Day 90, Day 150, Day 240, Day 330
Title
Point of Maximal Upper Arm Skin Laxity and Circumference Measurements by blinded investigator done to assess change.
Description
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
Time Frame
Baseline, Day 90, Day 150, Day 240, Day 330
Title
Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator
Description
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
Time Frame
Day 90, Day 150, Day 240, Day 330
Title
Blinded Identification of Correct Treatment Area Photographic Assessment by blinded investigator
Description
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)
Time Frame
Day 330
Secondary Outcome Measure Information:
Title
Subject Global Aesthetic Improvement Scale (SGIAS)
Description
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
Time Frame
Day 90, Day 150, Day 240, Day 330
Title
Subject Satisfaction Questionnaire
Description
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
Time Frame
Day 90, Day 150, Day 240, Day 330
Title
Evaluation of side effects and adverse effects will be completed by the investigators.
Description
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
Time Frame
Baseline, Day 30, Day 60, Day 90, Day 150, Day 240, Day 330
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Pacheco
Phone
8586571004
Email
apacheco@clderm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sherif Mikhail, MD
Phone
8586571004
Email
smikhail@westderm.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Sculptra to Aid in Treatment of Arm Laxity
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