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

NCT ID: NCT03858543

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2021-01-31

Brief Summary

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

Detailed Description

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Striae Distensae (SD) is a form of scarring that can oftentimes be quite disfiguring and emotionally distressing to individuals.

Fractional laser therapy has been used by doctors to treat stretch marks by stimulating collagen growth.

Poly-L lactic acid also promotes collagen growth in the areas injected.

The combination of laser and poly-L lactic acid might provide the optimal treatment modality for SD by decreasing the appearance of atrophic scars.

Conditions

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Striae Distensae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

Poly-L Lactic Acid

Intervention Type DRUG

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.

Fractional laser treatment

Intervention Type DEVICE

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.

Fractional laser treatment

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

Group Type ACTIVE_COMPARATOR

Fractional laser treatment

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DEVICE

Other Intervention Names

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Sculptra Sciton Laser

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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aamir siddiqui

Division Head - Plastic & Reconstruction Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Henry Ford Health System

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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11951

Identifier Type: -

Identifier Source: org_study_id

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