Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions.

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris; LASER
• Intervention / Treatment: Device: LASER MILESMAN 445 NM

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • La Coruña
    • Santiago de Compostela, La Coruña, Spain, 15702
      • GAIAS RESEARCH,C/PINTOR XAIME QUESADA Nº3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Laser application ( BEFORE/AFTER); 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.

Device: LASER MILESMAN 445 NM; Laser application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
How many lesions treated have disappeared	Number of lesions before laser vs. number of lesions after laser(72 h and 1 week ).	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by MedRA	The number of related adverse reactions is collected and cataloged.	2 weeks

Collaborators and Investigators

• Sponsor: Gaias Salud
• Collaborators: Gaias Research

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: LASER; ACNÉ; MILESMAN
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: MILESMAN-ACNE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No