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

Jose R. Reyes Memorial Medical Center16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Striae Gravidarum

Interventions

Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasmaPROCEDURE

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.

CO2 laser with PRPDEVICE

CO2 laser with PRP

CO2 laser with placeboDEVICE

CO2 laser with placebo

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Jose R Reyes Memorial Medical Center

Manila, NCR, Philippines

Outcomes

Primary Outcomes

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)

Time frame: 16 weeks

Secondary Outcomes

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.

Time frame: 16 weeks

Data from ClinicalTrials.gov

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