Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial
Overview
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Henry Ford Health System
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in Stretch Mark Size
Overview
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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Fractional laser treatment & Poly-L Lactic Acid (Sculptra)
One Fractional laser treatment on half of the body with Sciton Laser and Scluptra
Intervention: Poly-L Lactic Acid (Drug)
Fractional laser treatment & Poly-L Lactic Acid (Sculptra)
One Fractional laser treatment on half of the body with Sciton Laser and Scluptra
Intervention: Fractional laser treatment (Device)
Fractional laser treatment
One Fractional laser treatment on half of the body with Sciton Laser
Intervention: Fractional laser treatment (Device)
Outcomes
Primary Outcomes
Change in Stretch Mark Size
Time Frame: Baseline (Pre-treatment) vs. 3 Months, 4 Months, 5 Months, 6 Months
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.
Secondary Outcomes
- Treatments Superiority Assessment(6 Months)
Investigators
aamir siddiqui
Division Head - Plastic & Reconstruction Surgery
Henry Ford Health System