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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04956367
Enrollment
16
Registered
2021-07-09
Start date
2019-07-01
Completion date
2019-11-30
Last updated
2021-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Striae Gravidarum

Keywords

Striae Gravidarum, carbon dioxide laser, platelet-rich plasma

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.

Interventions

PROCEDUREAblative 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.

DEVICECO2 laser with PRP

CO2 laser with PRP

DEVICECO2 laser with placebo

CO2 laser with placebo

Sponsors

Jose R. Reyes Memorial Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Clinical improvement16 weeksChange 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

MeasureTime frameDescription
Patient satisfaction rate16 weeksSelf-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.

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026