NCT03858543

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

Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Striae Distensae

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-15
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2019-02-28
• Last updated: 2021-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study