Striae Distensae Clinical Trial
— FADeSOfficial title:
Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial
Verified date | August 2021 |
Source | Henry Ford Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-L lactic acid (Sculptra).
Status | Completed |
Enrollment | 10 |
Est. completion date | January 31, 2021 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Health System | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System | Galderma R&D |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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