Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-L lactic acid (Sculptra).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional laser treatment & Poly-L Lactic Acid (Sculptra) | Experimental | One Fractional laser treatment on half of the body with Sciton Laser and Scluptra |
|
| Fractional laser treatment | Active Comparator | One Fractional laser treatment on half of the body with Sciton Laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly-L Lactic Acid | Drug | 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. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
Not provided
| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C482305 | New-Fill |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Fractional laser treatment | Device | 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. |
|
|
| 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 |