Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae (FADeS)

Henry Ford Health

Status and phase: Completed; Early Phase 1

Conditions: Striae Distensae

Treatments: Device: Fractional laser treatment; Drug: Poly-L Lactic Acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03858543

11951

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Device: Fractional laser treatment

Drug: Poly-L Lactic Acid

Fractional laser treatment

Active Comparator group

Description:

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

Treatment:

Device: Fractional laser treatment