Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04698239 |
| Other study ID # |
MILESMAN-ACNE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 24, 2020 |
| Est. completion date |
February 15, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Gaias Salud |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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
