Clinical trial NCT05445661: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Laxity
Keywords: Skin
Volume
Volume Loss
Arms
Cosmetic
Lead sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2022-07-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, single-site, double-blinded, split-body, randomized controlled trial.
Primary purpose: TREATMENT

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.

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.

  1. 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.
  2. 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

Primary outcomes:
measure: 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
measure: 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
measure: Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator
timeFrame: Day 90, Day 150, Day 240, Day 330
measure: Blinded Identification of Correct Treatment Area Photographic Assessment by blinded investigator
timeFrame: Day 330
Secondary outcomes:
measure: Subject Global Aesthetic Improvement Scale (SGIAS)
timeFrame: Day 90, Day 150, Day 240, Day 330
measure: Subject Satisfaction Questionnaire
timeFrame: Day 90, Day 150, Day 240, Day 330
measure: Evaluation of side effects and adverse effects will be completed by the investigators.
timeFrame: Baseline, Day 30, Day 60, Day 90, Day 150, Day 240, Day 330
Other outcomes:
Locations:
Study officials:
References: