Efficacy of Fractional Carbon Dioxide Laser Combined With Platelet-rich Plasma

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Efficacy of Ablative Fractional Carbon Dioxide Laser Combined With Autologous Platelet-rich Plasma Versus Ablative Fractional Carbon Dioxide Laser and Placebo in the Treatment of Striae Gravidarum: a Randomized Clinical Trial

Conditions
-----------------
Striae Gravidarum

Intervention / Treatment
-----------------
* Procedure: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma
* Device: CO2 laser with PRP
* Device: CO2 laser with placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postpartum patients with ages 18 to 45 years Fitzpatrick skin type III-V having bilateral symmetrical SG of red, white or a combination of both types. Exclusion Criteria: pregnancy breastfeeding heavy consumption of alcoholic beverages dermatological conditions such as psoriasis, systemic lupus erythematosus and atopic dermatitis uncontrolled hypertension, diabetes mellitus, heart disease, acute and chronic liver/kidney impairment/disease; elevated liver function tests (SGPT, SGOT), and serum creatinine; intake of any medications that may influence the outcome of the study; intake of any vitamins/minerals or any supplements in the past 6 months; and application of any topical agents (e.g., whitening, anti-aging) in the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO2 laser with PRP<br>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. | Procedure: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma<br>* 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.<br>Device: CO2 laser with PRP<br>* CO2 laser with PRP<br>|
| Placebo Comparator: CO2 laser with placebo<br>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. | Procedure: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma<br>* 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.<br>Device: CO2 laser with placebo<br>* CO2 laser with placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Striae Gravidarum, carbon dioxide laser, platelet-rich plasma