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

Jose R. Reyes Memorial Medical Center

Status and phase: Completed; Phase 3

Conditions: Striae Gravidarum

Treatments: Device: CO2 laser with placebo; Procedure: Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma; Device: CO2 laser with PRP

Study type: Interventional

Funder types: Other

Identifiers

NCT04956367

2019-054

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

CO2 laser with PRP

Experimental group

Description:

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.

Treatment:

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

Device: CO2 laser with PRP

CO2 laser with placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: CO2 laser with placebo

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