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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Injectable biostimulant for volume loss
Sham Comparator
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
Time frame: 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
Time frame: 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 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
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Time frame: 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: 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)
Time frame: Day 330
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 1. Very Much Improved: Optimal cosmetic result 2. Much Improved: Marked improvement in appearance form the initial condition, but not completely optimal 3. Improved: Obvious improvement in appearance from initial condition 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 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
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 1. Somewhat satisfied 2. Satisfied 3. Very satisfied 4. 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
Evaluation of side effects and adverse effects will be completed by the investigators.
Treating Investigator Evaluation of Side Effects Rating Description 0 NONE: Normal 1. TRACE: Barely visible and localized 2. MILD: Somewhat visible and diffuse 3. MODERATE: Visible and diffuse 4. 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