NCT03858543

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

February 18, 2019

Last Update Submit

August 24, 2021

Conditions

Striae Distensae

Keywords

Stretch marksFractional laser therapyPoly-L lactic acidSculptra

Outcome Measures

Primary Outcomes (1)

  • Change in Stretch Mark Size

    Modified Manchester Scar Scale was used to assess stretch mark reduction compared to pre-treatment photographs. The range of each subscale is between 4-26. A higher value represents a worse outcome. A value of 26 is the maximum score and represents the worst outcome. A value of 4 is the minimum score and represents the best outcome. Subscales are then summed to compute a total score.

    Baseline (Pre-treatment) vs. 3 Months, 4 Months, 5 Months, 6 Months

Secondary Outcomes (4)

  • Treatments Superiority Assessment

    3 Months

  • Treatments Superiority Assessment

    4 Months

  • Treatments Superiority Assessment

    5 Months

  • Treatments Superiority Assessment

    6 Months

Study Arms (2)

Fractional laser treatment & Poly-L Lactic Acid (Sculptra)

EXPERIMENTAL

One Fractional laser treatment on half of the body with Sciton Laser and Scluptra

Drug: Poly-L Lactic AcidDevice: Fractional laser treatment

Fractional laser treatment

ACTIVE COMPARATOR

One Fractional laser treatment on half of the body with Sciton Laser

Device: Fractional laser treatment

Interventions

Poly-L Lactic AcidDRUG

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.

Also known as: Sculptra
Fractional laser treatment & Poly-L Lactic Acid (Sculptra)
Fractional laser treatmentDEVICE

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.

Also known as: Sciton Laser
Fractional laser treatmentFractional laser treatment & Poly-L Lactic Acid (Sculptra)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has bilateral striae alba
  • Subject has stable body weight for at least 6 months with Fitzpatrick skin type 1-4

You may not qualify if:

  • Subject has striae rubra
  • Pregnant
  • History of adverse effects to phototherapy
  • Subject has single sided lesions
  • Subject has immunosuppression
  • Subject has radiation therapy to the study area
  • Subject has topical or oral steroid use or chemotherapy within the last 6 months
  • History of keloids or hypertrophic scar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Striae Distensae

Interventions

New-Fill

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head - Plastic & Reconstruction Surgery

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 28, 2019

Study Start

July 15, 2019

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

US(1)