Treatment of Inflammatory Facial Acne Vulgaris with a Solid-state Dual Wavelength 1,319 and 589 nm Laser and 2.5% Benzoyl peroxide Versus 2.5% Benzoyl peroxide alone: A Split Face, Randomized Controlled Trial

Phase 4

• Conditions: Patients who have moderate bilateral facial inflammatory acne; inflammatory acne, acne vulgaris, laser, dual wavelength laser

• Registration Number: TCTR20221003006
• Lead Sponsor: Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-03
• Study Completion: 2023-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Healthy males and females between 18 to 50 years old
2.Patients who have moderate bilateral facial inflammatory acne with the presence of at least five acne papules or pustules per each side of the face
3.Fitzpatrick skin Types III to V
4.Patients willing to follow up and comply with the study
protocol who appreciates to participate in this study by signing the consent form

Exclusion Criteria

1.Pregnant or lactating woman
2.Patients who had received oral vitamin A derivatives in the past 3 months
3.Patients who had received any other systemic or topical acne therapies, alpha hydroxy acid or glycolic acid, beta hydroxy acid or salicylic acid within 1 month
4.Patients who had received oral contraceptives for within 3 months
5.Patients receiving facial laser treatments within the past 3 months
6.Patients with history of photosensitive disease
7.Patients with any medical condition that might affect acne and wound healing process
8.Patients who withdrew from the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory acne lesion count at baseline, week 2, week 4, week 6, week 10, week 14 and week 18 The number counted

Secondary Outcome Measures

Name	Time	Method
Facial acne severity at baseline, week 2, week 4, week 6, week 10, week 14 and week 18 Investigator's Global Assessment (IGA) of acne severity,Improvement of facial post-acne erythema at baseline, week 2, week 4, week 6, week 10, week 14 and week 18 Antera 3D skin analysis camera ,Improvement of facial acne scar and/or skin texture at baseline, week 6, week 10, week 14 and week 18 Antera 3D skin analysis camera,Pain score assessment at week 0, week 2, week 4 and week 6 Visual analogue scale from 0 to 10 ,Patient satisfaction score at week 6, week 10, week 14 and week 18 Visual analogue scale from 0 to 10,Safety every visit side effects