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Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae (FADeS)

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ClinicalTrials.gov Identifier: NCT03858543
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Galderma
Information provided by (Responsible Party):
aamir siddiqui, Henry Ford Health System

Study Description
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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).

Condition or disease Intervention/treatment Phase
Striae Distensae Drug: Poly-L Lactic Acid Device: Fractional laser treatment Early Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : May 11, 2020
Estimated Study Completion Date : May 11, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fractional laser treatment & Poly-L Lactic Acid (Sculptra)
One Fractional laser treatment on half of the body with Sciton Laser and Scluptra
 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.
Other Name: Sculptra

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.
Other Name: Sciton Laser
Active Comparator: Fractional laser treatment
One Fractional laser treatment on half of the body with Sciton Laser
 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.
Other Name: Sciton Laser


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858543


Contacts
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Contact: Aamir Siddiqui, M.D. 313-916-2683 ASIDDIQ1@hfhs.org

Locations
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United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Aamir Siddiqui, M.D.    313-916-2683    ASIDDIQ1@hfhs.org   
Principal Investigator: Aamir Siddiqui, M.D.         
Sponsors and Collaborators
Henry Ford Health System
Galderma
More Information
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Responsible Party: aamir siddiqui, Division Head - Plastic & Reconstruction Surgery, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03858543    
Other Study ID Numbers: 11951
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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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
Keywords provided by aamir siddiqui, Henry Ford Health System:
Stretch marks
Fractional laser therapy
Poly-L lactic acid
Sculptra
Additional relevant MeSH terms:
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Striae Distensae
Skin Manifestations