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NCT Number: NCT04956367

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

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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Key information

Conditions

Striae Gravidarum Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations Striae Distensae

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Jose R Reyes Memorial Medical Center

Manila, NCR, 1014, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

CO2 laser with PRP

CO2 laser with placebo

Device

CO2 laser with placebo

Primary outcomes

  1. Clinical improvement

    Time frame: 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 outcomes

  1. Patient satisfaction rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jose R. Reyes Memorial Medical Center

Other Gov

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2021
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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