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

Overview

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

Full Title of Study: “Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 31, 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Fractional laser treatment & Poly-L Lactic Acid (Sculptra)
    • One Fractional laser treatment on half of the body with Sciton Laser and Scluptra
  • Active Comparator: Fractional laser treatment
    • One Fractional laser treatment on half of the body with Sciton Laser

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Treatments Superiority Assessment
    • Time Frame: 3 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.
  • Treatments Superiority Assessment
    • Time Frame: 4 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.
  • Treatments Superiority Assessment
    • Time Frame: 5 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.
  • Treatments Superiority Assessment
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Henry Ford Health System
  • Collaborator
    • Galderma R&D
  • Provider of Information About this Clinical Study
    • Principal Investigator: aamir siddiqui, Division Head – Plastic & Reconstruction Surgery – Henry Ford Health System

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