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

Early Phase 1

Completed

• Conditions: Striae Distensae
• Interventions: Device: Fractional laser treatment; Drug: Poly-L Lactic Acid

• Registration Number: NCT03858543
• Lead Sponsor: Henry Ford Health System

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 Timeline

• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-02-28
• Study Start: 2019-07-15
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractional laser treatment	Fractional laser treatment	One Fractional laser treatment on half of the body with Sciton Laser
Fractional laser treatment & Poly-L Lactic Acid (Sculptra)	Poly-L Lactic Acid	One Fractional laser treatment on half of the body with Sciton Laser and Scluptra
Fractional laser treatment & Poly-L Lactic Acid (Sculptra)	Fractional laser treatment	One Fractional laser treatment on half of the body with Sciton Laser and Scluptra

Primary Outcome Measures

Name	Time	Method
Change in Stretch Mark Size	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 Outcome Measures

Name	Time	Method
Treatments Superiority Assessment	6 Months	Modified Manchester Scar Scale was used to assess and judge whether erbium-YAG fractionated laser therapy plus Sculptra is superior to laser therapy alone. 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.

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States