Sculptra to Aid in Treatment of Arm Laxity (NCT05445661) | Clinical Trial Compass
UnknownNot Applicable
Sculptra to Aid in Treatment of Arm Laxity
20 participantsStarted 2022-07-20
Plain-language 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).
Who can participate
Age range
40 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Upper Inner Arm Visual Skin Crepiness/Laxity Grading Scale by blinded investigator will be done to assess change.
Timeframe: Baseline, Day 90, Day 150, Day 240, Day 330
2
Point of Maximal Upper Arm Skin Laxity and Circumference Measurements by blinded investigator done to assess change.
Timeframe: Baseline, Day 90, Day 150, Day 240, Day 330
3
Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator
Timeframe: Day 90, Day 150, Day 240, Day 330
4
Blinded Identification of Correct Treatment Area Photographic Assessment by blinded investigator