Sculptra to Aid in Treatment of Arm Laxity

NCT05445661 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-07-06

No results posted yet for this study

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

Interventions

DEVICE

injectable poly-L-lactic acid

Injectable biostimulant for volume loss

OTHER

Normal Saline

Sham Comparator

Sponsors & Collaborators

  • Galderma R&D

    collaborator INDUSTRY
  • Goldman, Butterwick, Fitzpatrick and Groff

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2023-09-20
Completion
2023-09-20
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05445661 on ClinicalTrials.gov