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

NCT04956367 | Completed Phase 3 FDA Device

• 1 other identifier: 2019-054
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Striae Gravidarum

Keywords

Striae Gravidarum; carbon dioxide laser; platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction rate

  16 weeks

Study Arms (2)

CO2 laser with PRP

EXPERIMENTAL

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; Device: CO2 laser with PRP

CO2 laser with placebo

PLACEBO COMPARATOR

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; Device: CO2 laser with placebo

Interventions

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

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 PRP; CO2 laser with placebo

CO2 laser with PRP DEVICE

CO2 laser with PRP

CO2 laser with PRP

CO2 laser with placebo DEVICE

CO2 laser with placebo

CO2 laser with placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jose R. Reyes Memorial Medical Center: lead

Study Sites (1)

Jose R Reyes Memorial Medical Center

Manila, NCR, 1014, Philippines

Location

Related Publications (1)

• 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.

  PMID: 26924405 RESULT

MeSH Terms

Conditions

Striae Distensae

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Ivan Arni C Preclaro, MD

  Jose R. Reyes Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Used a computer-generated software to randomize the area to be treated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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 Record Dates

• First Submitted: June 22, 2021
• First Posted: July 9, 2021
• Study Start: July 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: November 30, 2019
• Last Updated: July 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)