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

• Sponsor: Jose R. Reyes Memorial Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04956367
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Striae Gravidarum	Procedure: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma; Device: CO2 laser with PRP; Device: CO2 laser with placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Used a computer-generated software to randomize the area to be treated.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Nov 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical improvement [16 weeks]

   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)

Secondary Outcome Measures

1. Patient satisfaction rate [16 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jose R Reyes Memorial Medical Center	Manila	NCR	Philippines	1014

Sponsors and Collaborators

• Jose R. Reyes Memorial Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ivan Arni Preclaro, 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, Jose R. Reyes Memorial Medical Center
• ClinicalTrials.gov Identifier: NCT04956367
• Other Study ID Numbers: 2019-054
• First Posted: Jul 9, 2021
• Last Update Posted: Jul 9, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Ivan Arni Preclaro, 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, Jose R. Reyes Memorial Medical Center: Striae Gravidarum; carbon dioxide laser; platelet-rich plasma
• Additional relevant MeSH terms: Striae Distensae

Study Results

No Results Posted as of Jul 9, 2021