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

Phase 3

Completed

• Conditions: Striae Gravidarum

• Registration Number: NCT04956367
• Lead Sponsor: Jose R. Reyes Memorial Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-11-30
• Status Verified: 2021-06
• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Study First Posted: 2021-07-09
• Last Update Posted: 2021-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical improvement	16 weeks	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

Name	Time	Method
Patient satisfaction rate	16 weeks	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.

Trial Locations

Locations (1)

Jose R Reyes Memorial Medical Center; 🇵🇭 Manila, NCR, Philippines