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This study determined the efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser with placebo in the treatment of striae gravidarum of postpartum Filipino women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO2 laser with PRP | Experimental | After anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, PRP will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals. |
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| CO2 laser with placebo | Placebo Comparator | After anesthetizing the area and undergo one pass of ablative fractional CO2 laser (Smaxel, iDS, Korea) using the following settings: energy = 50 mJ; pulse duration = 2 ms; and density level = 15, pNSS will be injected through nappage technique at 1 cm intervals for three treatment sessions at four-week intervals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma | Procedure | Carbon dioxide laser (Smaxel.878.4810) was FDA-approved device used in dermatology practice. PRP was described as having growth factors to be used to promote healing. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement | Change in appearance based from clinical photos done in baseline, week 6, week 10, week 14 and week 16 . This will be assessed by quartile grading scale (poor, <25% improvement; fair, 25-50% improvement; good, 51-75% improvement; and excellent, >75% improvement) | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction rate | Self-reported by the patient using a quartile grading system with the following grades: 0 as poor; 1 as fair; 2 as satisfied; or 3 as very satisfied. The rating will be done at weeks 6, 10, 14 and 16. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Arni C Preclaro, MD | Jose R. Reyes Memorial Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jose R Reyes Memorial Medical Center | Manila | NCR | 1014 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26924405 | Result | Faghihi G, Keyvan S, Asilian A, Nouraei S, Behfar S, Nilforoushzadeh MA. Efficacy of autologous platelet-rich plasma combined with fractional ablative carbon dioxide resurfacing laser in treatment of facial atrophic acne scars: A split-face randomized clinical trial. Indian J Dermatol Venereol Leprol. 2016 Mar-Apr;82(2):162-8. doi: 10.4103/0378-6323.174378. |
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| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054020 | Lasers, Gas |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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Used a computer-generated software to randomize the area to be treated.
| CO2 laser with PRP | Device | CO2 laser with PRP |
|
| CO2 laser with placebo | Device | CO2 laser with placebo |
|