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

NCT06867276 | Completed

• 1 other identifier: Sohaila-004677
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Level Laser Therapy; Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• assessment of change of Global Assessment Scale

  For the study, we recruited males and females with mild to moderate acne according to the Investigator's Global Assessment (IGA) scale, where the severity of acne and the type of lesions was assigned to it. the scoring ranges from 0 to 4. Zero indicates clear skin with no inflammatory and non- inflammatory lesions, while 4 indicates severe lesion with Many comedones and inflammatory lesions, ≤ several nodules and cysts

  At baseline and after 4 weeks

Secondary Outcomes (1)

• assesment of change of digital facial photographs

  At baseline and after 4 weeks

Study Arms (2)

Excimer laser

EXPERIMENTAL

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).

Device: Excimer laser

Bioptron

ACTIVE COMPARATOR

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.

Device: Bioptron Pro 1

Interventions

Excimer laser 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.

Excimer laser

Bioptron Pro 1 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.

Bioptron

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female and male patients.
• Age range between 18 and 25 years.
• All patients will sign their informed consent to participate in the research procedure and to publish the data.
• 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.

You may not qualify if:

• Patient's unwillingness to continue cooperation in the study
• Photosensitive skin.
• Pregnancy and breast feeding.
• Women who use hormonal contraceptives.
• Patients who had used oral retinoids or any other treatment for acne in the last month.
• Patients with severe nodulocystic acne

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Lasers, Excimer

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 10, 2025
• Study Start: January 15, 2024
• Primary Completion: November 22, 2024
• Study Completion: December 22, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)