Low Level Laser Versus Polarized Light in the Treatment of Acne Vulgaris

NCT ID: NCT06867276

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-12-22

Brief Summary

The present study is designed to compare clinically the therapeutic applications between low level laser therapy (excimer laser) and non-laser polarized light (Bioptron prol) in the treatment of Acne vulgaris.

Detailed Description

Traditional acne treatment often involves topical application, which can cause skin irritation and dryness, and oral antibiotic therapy, which is limited by antibiotic resistance. Newer procedures like laser and light-based therapies offer alternative treatments for patients who struggle with adherence or experience side effects or treatment failure. This study aims to compare the therapeutic application of laser and light therapies as an alternative to traditional acne treatments.

Conditions

Low Level Laser Therapy; Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Excimer laser

This group includes 25 patients; all the participants received low level laser (Excimer laser) in a series of eight treatment sessions that was performed twice per week. The radiation exposure time is 10 minutes during the procedure, a maximum dose of 0.65 J/cm², and 6 different spot sizes to avoid healthy skin. large spot size (20 cm²).

Group Type: EXPERIMENTAL

Excimer laser

Intervention Type: DEVICE

Excimer laser patients undergo ultraviolet b phototherapy treatments at a physical medicine clinic twice a week for four weeks. The device uses a 308nm beam of coherent light, with six spot sizes to avoid healthy skin. The radiation exposure time is 10 minutes, with a maximum dose of 0.65 J/cm². Personal protection standards include wearing protective eyewear for the retina and choroid, as they absorb visible light radiation, which can cause keratoconjunctivitis or cataracts. The thermal effect of the laser can cause superficial carbonization of the epidermis, phlyctens, or erythema, so non-flammable gloves are recommended.

Bioptron

This group includes 25 patients; all the participants received polarized light (Bioptron Pro l) in a series of eight treatment sessions that was performed twice per week. The radiation exposure time is 10 minutes during the procedure; a device is fixed at a distance of 10 cm from the treatment area (face), light spot size 19 cm2 average power density is 40 mille watt per cm², and a dose of 2.4 J/cm² per minute.

Group Type: ACTIVE_COMPARATOR

Bioptron Pro 1

Intervention Type: DEVICE

Patients undergone Bioptron light treatment twice weekly for four weeks at a physical medicine clinic. The treatment is administered by a physiatrist following the manufacturer's user guide. Patients sit in a comfortable chair with their hand on an armrest, holding the Bioptron light probe at a 90° angle for 10 minutes.

Interventions

Excimer laser

Excimer laser patients undergo ultraviolet b phototherapy treatments at a physical medicine clinic twice a week for four weeks. The device uses a 308nm beam of coherent light, with six spot sizes to avoid healthy skin. The radiation exposure time is 10 minutes, with a maximum dose of 0.65 J/cm². Personal protection standards include wearing protective eyewear for the retina and choroid, as they absorb visible light radiation, which can cause keratoconjunctivitis or cataracts. The thermal effect of the laser can cause superficial carbonization of the epidermis, phlyctens, or erythema, so non-flammable gloves are recommended.

Intervention Type: DEVICE

Bioptron Pro 1

Patients undergone Bioptron light treatment twice weekly for four weeks at a physical medicine clinic. The treatment is administered by a physiatrist following the manufacturer's user guide. Patients sit in a comfortable chair with their hand on an armrest, holding the Bioptron light probe at a 90° angle for 10 minutes.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Female and male patients.

2. Age range between 18 and 25 years.

3. All patients will sign their informed consent to participate in the research procedure and to publish the data.

4. Definite clinical diagnosis of mild to moderate inflammatory lesions of facial Acne vulgaris (open and closed comedones, papules, pustules, and nodules) on the face that has been going on for at least 1 month.

Exclusion Criteria

1. Patient's unwillingness to continue cooperation in the study

2. Photosensitive skin.

3. Pregnancy and breast feeding.

4. Women who use hormonal contraceptives.

5. Patients who had used oral retinoids or any other treatment for acne in the last month.

6. Patients with severe nodulocystic acne

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sohila Mamdouh Morsy Mohamed

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

out-patient clinic, faculty of physical therapy, Cairo university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Sohaila-004677

Identifier Type: -

Identifier Source: org_study_id