Low Level Laser TherapyNCT06867276
Low Level Laser Versus Polarized Light in the Treatment of Acne Vulgaris
A study testing Excimer laser and Bioptron Pro 1 in people with Low Level Laser Therapy and Acne Vulgaris, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Low Level Laser Therapy, Acne Vulgaris
- What is being tested?
- Excimer laser and Bioptron Pro 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 22 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
out-patient clinic, faculty of physical therapy, Cairo university
Cairo
About this study
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.
Read the 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
- Being tested
- Excimer laser, Bioptron Pro 1
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excimer laserDevice
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 Pro 1Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Bioptron Pro 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and after 4 weeks
Secondary outcomes (1)
assesment of change of digital facial photographs
Digital Facial photographs, included in the photographic documentation, were taken by (Nikon Camera), before the procedure and four weeks after the end of the whole therapy.
Digital facial photographs will be taken for each patient at the base line and end of the fourth week to track the development of acne lesions and evaluate treatment effectiveness, using the same method for each patient.
Measured: At baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start15 Jan 2024
- Primary completion22 Nov 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Level Laser TherapyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohila Mamdouh Morsy Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867276
- Sponsor's protocol ID
- Sohaila-004677
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Versus Polarized Light in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06867276
- Acronym / sponsor ID
- Sohaila-004677
- Conditions
- Low Level Laser Therapy, Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excimer laser | Experimental | Device: Excimer laserThis 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). |
| Bioptron | Active comparator | Device: Bioptron Pro 1This 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excimer laserExcimer 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. | Device | Excimer laser |
| Bioptron Pro 1Patients 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. | Device | Bioptron |
Primary outcome
assessment of change of Global Assessment Scale
Time frame: At baseline and after 4 weeks
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
1 secondary outcome
assesment of change of digital facial photographs
Time frame: At baseline and after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Low Level Laser Therapy
Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Not yet recruiting
Acute Effects of High-Intensity Laser Therapy on Pain, Muscle Stiffness, and Grip Strength in Healthy Adults
Exercise-Induced Muscle Fatigue, Fatigue Recovery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excimer laser and Bioptron Pro 1 in people with Low Level Laser Therapy and Acne Vulgaris, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of change of Global Assessment Scale (time frame: At baseline and after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.