Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae
NCT ID: NCT03858543
Last Updated: 2021-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
10 participants
INTERVENTIONAL
2019-07-15
2021-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fractional laser treatment & Poly-L Lactic Acid (Sculptra)
One Fractional laser treatment on half of the body with Sciton Laser and Scluptra
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.
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.
Fractional laser treatment
One Fractional laser treatment on half of the body with Sciton Laser
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has stable body weight for at least 6 months with Fitzpatrick skin type 1-4
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Henry Ford Health System
OTHER
Responsible Party
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aamir siddiqui
Division Head - Plastic & Reconstruction Surgery
Locations
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Henry Ford Health System
Detroit, Michigan, United States
Countries
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Other Identifiers
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11951
Identifier Type: -
Identifier Source: org_study_id
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