Sculptra to Aid in Treatment of Arm Laxity

NCT05445661 | Unknown FDA Device

• 1 other identifier: Sculptra-Arms-2022-02
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Skin Laxity

Keywords

Skin; Volume; Volume Loss; Arms; Cosmetic

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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)

  Day 330

Secondary Outcomes (3)

• Subject Global Aesthetic Improvement Scale (SGIAS)

  Day 90, Day 150, Day 240, Day 330

• Subject Satisfaction Questionnaire

  Day 90, Day 150, Day 240, Day 330

• Evaluation of side effects and adverse effects will be completed by the investigators.

  Baseline, Day 30, Day 60, Day 90, Day 150, Day 240, Day 330

Study Arms (2)

Injectable poly-L-lactic acid

EXPERIMENTAL

One of the subject's arms will be treated with injectable poly-L-lactic acid (PLLA, Sculptra® Aesthetic; Galderma Laboratories; Fort Worth, TX).

Device: injectable poly-L-lactic acid

Normal Saline

SHAM COMPARATOR

One of the subject's arms will be treated with injectable normal saline

Other: Normal Saline

Interventions

injectable poly-L-lactic acid DEVICE

Injectable biostimulant for volume loss

Also known as: PLLA, Sculptra, Sculptra Aesthetic, Galderma

Injectable poly-L-lactic acid

Normal Saline OTHER

Sham Comparator

Normal Saline

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• Galderma R&D: collaborator

MeSH Terms

Conditions

Cutis Laxa; Rhabdomyosarcoma, Alveolar

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Rhabdomyosarcoma; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Andrea Pacheco

CONTACT

8586571004; apacheco@clderm.com

Sherif Mikhail, MD

CONTACT

8586571004; smikhail@westderm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-site, double-blinded, split-body, randomized controlled trial.

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: July 6, 2022
• Study Start: July 20, 2022
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-06