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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial

Conditions
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Striae Distensae

Intervention / Treatment
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* Drug: Poly-L Lactic Acid
* Device: Fractional laser treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractional laser treatment & Poly-L Lactic Acid (Sculptra)<br>One Fractional laser treatment on half of the body with Sciton Laser and Scluptra | Drug: Poly-L Lactic Acid<br>* 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.<br>* Other names: Sculptra;Device: Fractional laser treatment<br>* 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.<br>* Other names: Sciton Laser;|
| Active Comparator: Fractional laser treatment<br>One Fractional laser treatment on half of the body with Sciton Laser | Device: Fractional laser treatment<br>* 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.<br>* Other names: Sciton Laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Pre-treatment) vs. 3 Months, 4 Months, 5 Months, 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 Months | 
| 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. | 4 Months | 
| 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. | 5 Months | 
| 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. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stretch marks, Fractional laser therapy, Poly-L lactic acid, Sculptra