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

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

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 Overview

• Status: Completed
• 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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 3

Contacts and Locations

Study Locations

• Philippines
  • NCR
    • Manila, NCR, Philippines, 1014
      • Jose R Reyes Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CO2 laser with PRP; 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; 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.; Device: CO2 laser with PRP; CO2 laser with PRP
Placebo Comparator: CO2 laser with placebo; 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; 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.; Device: CO2 laser with placebo; CO2 laser with placebo

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

Collaborators and Investigators

• Sponsor: Jose R. Reyes Memorial Medical Center
• Investigators: Principal Investigator: Ivan Arni C Preclaro, MD, Jose R. Reyes Memorial Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Striae Gravidarum; platelet-rich plasma; carbon dioxide laser
• Additional Relevant MeSH Terms: Skin Manifestations; Striae Distensae
• Other Study ID Numbers: 2019-054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes