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

NCT04698239 | Completed

• 1 other identifier: MILESMAN-ACNE
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne Vulgaris; LASER

Keywords

LASER; ACNÉ; MILESMAN

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by MedRA

  2 weeks

Study Arms (1)

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.

Device: LASER MILESMAN 445 NM

Interventions

LASER MILESMAN 445 NM DEVICE

Laser application

Laser application ( BEFORE/AFTER)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaias Salud: lead
• Gaias Research: collaborator

Study Sites (1)

GAIAS RESEARCH,C/PINTOR XAIME QUESADA Nº3

Santiago de Compostela, La Coruña, 15702, Spain

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: January 6, 2021
• Study Start: September 24, 2020
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)