Ignite Creation Date:
2025-12-24 @ 12:48 PM
Ignite Modification Date:
2025-12-27 @ 4:10 PM
Study NCT ID:
NCT05445661
Status:
UNKNOWN
Last Update Posted:
2022-07-06
First Post:
2022-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sculptra to Aid in Treatment of Arm Laxity
Sponsor:
Goldman, Butterwick, Fitzpatrick and Groff
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: