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

Striae Gravidarum Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04956367
• Other study ID #: 2019-054
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: June 2021
• Source: Jose R. Reyes Memorial Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 30, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Striae Distensae
• Striae Gravidarum

Intervention

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
• CO2 laser with placebo
CO2 laser with placebo

Locations

Country	Name	City	State
Philippines	Jose R Reyes Memorial Medical Center	Manila	NCR

Sponsors (1)

Lead Sponsor	Collaborator
Jose R. Reyes Memorial Medical Center

Country where clinical trial is conducted

Philippines, 

References & 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 cli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	16 weeks