Back to resultsFractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae (FADeS)
Primary Purpose
Striae Distensae
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Poly-L Lactic Acid
Fractional laser treatment
Sponsored by
About this trial
This is an interventional treatment trial for Striae Distensae focused on measuring Stretch marks, Fractional laser therapy, Poly-L lactic acid, Sculptra
Eligibility Criteria
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
Sites / Locations
- Henry Ford Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fractional laser treatment & Poly-L Lactic Acid (Sculptra)
Fractional laser treatment
Arm Description
One Fractional laser treatment on half of the body with Sciton Laser and Scluptra
One Fractional laser treatment on half of the body with Sciton Laser
Outcomes
Primary Outcome Measures
Change in Stretch Mark Size
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
Treatments Superiority Assessment
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
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
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
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.
Full Information
NCT ID
NCT03858543
First Posted
February 18, 2019
Last Updated
August 24, 2021
Sponsor
Henry Ford Health System
Collaborators
Galderma R&D
1. Study Identification
Unique Protocol Identification Number
NCT03858543
Brief Title
Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae
Acronym
FADeS
Official Title
Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
Galderma R&D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Striae Distensae
Keywords
Stretch marks, Fractional laser therapy, Poly-L lactic acid, Sculptra
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fractional laser treatment & Poly-L Lactic Acid (Sculptra)
Arm Type
Experimental
Arm Description
One Fractional laser treatment on half of the body with Sciton Laser and Scluptra
Arm Title
Fractional laser treatment
Arm Type
Active Comparator
Arm Description
One Fractional laser treatment on half of the body with Sciton Laser
Intervention Type
Drug
Intervention Name(s)
Poly-L Lactic Acid
Other Intervention Name(s)
Sculptra
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Fractional laser treatment
Other Intervention Name(s)
Sciton Laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Stretch Mark Size
Description
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.
Time Frame
Baseline (Pre-treatment) vs. 3 Months, 4 Months, 5 Months, 6 Months
Secondary Outcome Measure Information:
Title
Treatments Superiority Assessment
Description
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.
Time Frame
3 Months
Title
Treatments Superiority Assessment
Description
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.
Time Frame
4 Months
Title
Treatments Superiority Assessment
Description
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.
Time Frame
5 Months
Title
Treatments Superiority Assessment
Description
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.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae
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