Acne VulgarisNCT04698239
Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions.
A study testing LASER MILESMAN 445 NM in people with Acne Vulgaris and LASER, run by Gaias Salud at 1 site in Spain.
Trial summary
Acne treatment by laser or other light devices is a currently accepted procedure. It allows faster resolution of injuries, with fewer side effects and greater patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris, LASER
- What is being tested?
- LASER MILESMAN 445 NM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 24 Sep 2020to 15 Feb 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between 18 and 50 years old
- Diagnosis of mild to moderate acne on the face
- They must have 10 - 50 inflammatory lesions (papules and pustules) on the face
- In general good health
Who cannot join
- Allergies or light sensitivities.
- Severe acne or pre-existing dermatological facial condition
- Presence of cysts on the face
- More than one nodule on the face
- Having an uncontrolled disease or an immunodeficient disorder.
- Being pregnant or lactating
Show all 14Show fewer
- Oral and / or topical antibiotic treatment in the last 2 weeks.
- Current treatment with hormonal contraceptives.
- Impossibility of avoiding excessive sun exposure and any light treatment or any similar pro-fessional or aesthetic procedure during the 15 days before and 15 days after treatment.
- Previous history of poorly healed wounds, keloid formation, or bleeding disorders
- Process of active or historical infection of herpes simplex.
- Extreme sensitivity to hydroquinone or other bleaching agents.
- Personal or family history of melanoma.
- Dysplastic nevus.
Trial locations and contacts
1 site in 1 country.
Spain1 site
GAIAS RESEARCH,C/PINTOR XAIME QUESADA Nº3
Santiago de Compostela, La Coruña, 15702
About this study
Acne treatment by laser or other light devices is a currently accepted procedure. It allows faster resolution of injuries, with fewer side effects and greater patient satisfaction.
The mechanism of action of the Milesman Blauman laser is based on diode laser technology that produces pulses of blue light with a wavelength of 445 nanometers, in the blue and visible spectrum. It combines the precision of laser technology by focusing energy on diseased areas.
Read the detailed description
Introduction / Justification Acne vulgaris (AV) is a polygenic multifactorial disease of the pilosebaceous units, which leads to the formation of both non-inflammatory lesions (comedones) and inflammatory lesions (papules, pustules, nodules and cysts), which affects approximately 85% of the population .
Acne treatment by laser or other light devices is a currently accepted procedure. It allows faster resolution of injuries, with fewer side effects and greater patient satisfaction.
The mechanism of action of the Milesman Blauman laser is based on diode laser technology that produces pulses of blue light with a wavelength of 445 nanometers, in the blue and visible spectrum. It combines the precision of laser technology by focusing energy on diseased areas.
The MILESMAN Laser has been on the market for over two years and has been used for cosmetic purposes and has proven to be safe during that time on the market.
MAIN GOAL The main objective of this study is to describe the efficacy and safety of the device (Milesman Laser) as a treatment for inflammatory acne lesions (papules and pustules). To do this, we will measure the evolution of the number of injuries of this type on the patient, before and after the application of the laser.
EXPLORATORY OBJECTIVES
Additionally, the study will have the following objectives:
- Exploratory assessment of the change in acne classification on the EGAE scale (grade 1 - 4) after laser application.
- Evaluate the adverse effects derived after the laser application.
- Evaluate the degree of patient satisfaction after the laser application. STUDY DESIGN Open, prospective, interventional, single-arm, quasi-experimental analytical study of before and after.
This type of design is based on the measurement and comparison of the response variable before and after the subject's exposure to the experimental intervention. It is a national, single-center study.
SAMPLE SIZE According to the objective of the study, we plan to get at least 25 patients. In this study we define sample as the entire area to be treated on the face, that is, we will obtain 25 samples.
STUDY PERIOD The duration of the study will be 3 months from the inclusion of the first patient. The duration of the patient in the study is 14 days.
DESCRIPTION OF THE INTERVENTION The Milesman laser has a handpiece, which allows each injury to be targeted via an indicator light and the person handling it will trigger the shot via a foot pedal. A maximum of 10 shots will be made on each acne injury, depending on the size and type of injury. Finally, 2-3 shots will be taken to photocoagulate the follicle walls and thus prevent the lesion from recurring or becoming infected again.
The laser will be applied to all inflammatory facial injuries in a single session, it is estimated that the duration of the session is about 20 minutes, depending on the number of injuries
- Conditions
- Acne Vulgaris, LASER
- Being tested
- LASER MILESMAN 445 NM
- Keywords
- LASER, ACNÉ, MILESMAN
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASER MILESMAN 445 NMDevice
Laser application
| Study group | Role | What they receive |
|---|---|---|
| Laser application ( BEFORE/AFTER) | Experimental | All patients will receive a maximum of 13 laser pulses in each lesion. We are going to make a comparison of the before and after the treatment, it is the patient himself who checks himself.
The number of lesions will be counted before treatment and after treatment(72-hour and 1-week ) . Adverse reactions will be collected at several visits as well, during the 2 weeks that the patient is included in the study. Receives: Device: LASER MILESMAN 445 NM |
What is being measured
The primary outcome is the main question the study is designed to answer.
How many lesions treated have disappeared
Number of lesions before laser vs. number of lesions after laser(72 h and 1 week ).
Measured: 1 week
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by MedRA
The number of related adverse reactions is collected and cataloged.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start24 Sep 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaias Salud
- Sponsor type
- Research network
- Collaborators
- Gaias Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698239
- Sponsor's protocol ID
- MILESMAN-ACNE
- Status last verified
- Mar 2021
- First submitted
- 6 Oct 2020
- Last updated
- 15 Mar 2021
- 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 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions.
- ClinicalTrials.gov ID
- NCT04698239
- Acronym / sponsor ID
- MILESMAN-ACNE
- Conditions
- Acne Vulgaris, LASER
- Keywords
- LASER, ACNÉ, MILESMAN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gaias SaludResearch network
- Collaborators
- Gaias Research
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 6 Jan 2021 (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.
Acne treatment by laser or other light devices is a currently accepted procedure. It allows faster resolution of injuries, with fewer side effects and greater patient satisfaction.
The mechanism of action of the Milesman Blauman laser is based on diode laser technology that produces pulses of blue light with a wavelength of 445 nanometers, in the blue and visible spectrum. It combines the precision of laser technology by focusing energy on diseased areas.
Detailed description
Introduction / Justification Acne vulgaris (AV) is a polygenic multifactorial disease of the pilosebaceous units, which leads to the formation of both non-inflammatory lesions (comedones) and inflammatory lesions (papules, pustules, nodules and cysts), which affects approximately 85% of the population .
Acne treatment by laser or other light devices is a currently accepted procedure. It allows faster resolution of injuries, with fewer side effects and greater patient satisfaction.
The mechanism of action of the Milesman Blauman laser is based on diode laser technology that produces pulses of blue light with a wavelength of 445 nanometers, in the blue and visible spectrum. It combines the precision of laser technology by focusing energy on diseased areas.
The MILESMAN Laser has been on the market for over two years and has been used for cosmetic purposes and has proven to be safe during that time on the market.
MAIN GOAL The main objective of this study is to describe the efficacy and safety of the device (Milesman Laser) as a treatment for inflammatory acne lesions (papules and pustules). To do this, we will measure the evolution of the number of injuries of this type on the patient, before and after the application of the laser.
EXPLORATORY OBJECTIVES
Additionally, the study will have the following objectives:
- Exploratory assessment of the change in acne classification on the EGAE scale (grade 1 - 4) after laser application.
- Evaluate the adverse effects derived after the laser application.
- Evaluate the degree of patient satisfaction after the laser application. STUDY DESIGN Open, prospective, interventional, single-arm, quasi-experimental analytical study of before and after.
This type of design is based on the measurement and comparison of the response variable before and after the subject's exposure to the experimental intervention. It is a national, single-center study.
SAMPLE SIZE According to the objective of the study, we plan to get at least 25 patients. In this study we define sample as the entire area to be treated on the face, that is, we will obtain 25 samples.
STUDY PERIOD The duration of the study will be 3 months from the inclusion of the first patient. The duration of the patient in the study is 14 days.
DESCRIPTION OF THE INTERVENTION The Milesman laser has a handpiece, which allows each injury to be targeted via an indicator light and the person handling it will trigger the shot via a foot pedal. A maximum of 10 shots will be made on each acne injury, depending on the size and type of injury. Finally, 2-3 shots will be taken to photocoagulate the follicle walls and thus prevent the lesion from recurring or becoming infected again.
The laser will be applied to all inflammatory facial injuries in a single session, it is estimated that the duration of the session is about 20 minutes, depending on the number of injuries
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser application ( BEFORE/AFTER) | Experimental | Device: LASER MILESMAN 445 NMAll patients will receive a maximum of 13 laser pulses in each lesion. We are going to make a comparison of the before and after the treatment, it is the patient himself who checks himself. The number of lesions will be counted before treatment and after treatment(72-hour and 1-week ) . Adverse reactions will be collected at several visits as well, during the 2 weeks that the patient is included in the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults between 18 and 50 years old
- Diagnosis of mild to moderate acne on the face
- They must have 10 - 50 inflammatory lesions (papules and pustules) on the face
- In general good health
Key exclusion criteria (14 listed)
- Allergies or light sensitivities.
- Severe acne or pre-existing dermatological facial condition
- Presence of cysts on the face
- More than one nodule on the face
- Having an uncontrolled disease or an immunodeficient disorder.
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 |
|---|---|---|
| LASER MILESMAN 445 NMLaser application | Device | Laser application ( BEFORE/AFTER) |
Primary outcome
How many lesions treated have disappeared
Time frame: 1 week
Number of lesions before laser vs. number of lesions after laser(72 h and 1 week ).
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by MedRA
Time frame: 2 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 15 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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 LASER MILESMAN 445 NM in people with Acne Vulgaris and LASER, run by Gaias Salud at 1 site in Spain.
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 14 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 15 Mar 2021. 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 Spain. 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?
How many lesions treated have disappeared (time frame: 1 week). 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 15 Mar 2021.