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

Primary Purpose

Striae Gravidarum

Status

Completed

Phase

Phase 3

Locations

Philippines

Study Type

Interventional

Intervention

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

CO2 laser with PRP

CO2 laser with placebo

About this trial

This is an interventional treatment trial for Striae Gravidarum focused on measuring Striae Gravidarum, carbon dioxide laser, platelet-rich plasma

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Jose R Reyes Memorial Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CO2 laser with PRP

CO2 laser with placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04956367

First Posted

June 22, 2021

Last Updated

July 8, 2021

Sponsor

Jose R. Reyes Memorial Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04956367

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

October 31, 2019 (Actual)

Study Completion Date

November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jose R. Reyes Memorial Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Striae Gravidarum

Keywords

Striae Gravidarum, carbon dioxide laser, platelet-rich plasma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

Used a computer-generated software to randomize the area to be treated.

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CO2 laser with PRP

Arm Type

Experimental

Arm Description

Arm Title

CO2 laser with placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

CO2 laser with PRP

Intervention Description

CO2 laser with PRP

Intervention Type

Device

Intervention Name(s)

CO2 laser with placebo

Intervention Description

CO2 laser with placebo

Primary Outcome Measure Information:

Title

Clinical improvement

Description

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Patient satisfaction rate

Description

Time Frame

16 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ivan Arni C Preclaro, MD

Organizational Affiliation

Jose R. Reyes Memorial Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jose R Reyes Memorial Medical Center

City

Manila

State/Province

NCR

ZIP/Postal Code

1014

Country

Philippines

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26924405

Citation

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.

Results Reference

result

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

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