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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Striae Gravidarum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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

Intervention Type DEVICE

CO2 laser with PRP

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.

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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 placebo

Intervention Type DEVICE

CO2 laser with placebo

Interventions

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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.

Intervention Type PROCEDURE

CO2 laser with PRP

Intervention Type DEVICE

CO2 laser with placebo

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR