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Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae

NCT03858543 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-08-26

No results posted yet for this study

Summary

This study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-L lactic acid (Sculptra).

Conditions

  • Striae Distensae

Interventions

DRUG

Poly-L Lactic Acid

After initial treatment, reassessment will be conducted at 3 follow-up visits. Photographs will be taken for blinded evaluators to compare post-treatment to the original pre-treatment photographs. At final visit, a questionnaire will be administered to rate treatment satisfaction.

DEVICE

Fractional laser treatment

After initial treatment, reassessment will be conducted at 3 follow-up visits. Photographs will be taken for blinded evaluators to compare post-treatment to the original pre-treatment photographs. At final visit, a questionnaire will be administered to rate treatment satisfaction.

Sponsors & Collaborators

  • Galderma R&D

    collaborator INDUSTRY

  • Henry Ford Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2021-01-31
Completion
2021-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03858543 on ClinicalTrials.gov