Status:
COMPLETED
Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions.
Lead Sponsor:
Gaias Salud
Collaborating Sponsors:
Gaias Research
Conditions:
Acne Vulgaris
LASER
Eligibility:
All Genders
18-50 years
Phase:
NA
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 a...
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 inflamma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04698239
Start Date
September 24 2020
End Date
February 15 2021
Last Update
March 15 2021
Active Locations (1)
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1
GAIAS RESEARCH,C/PINTOR XAIME QUESADA Nº3
Santiago de Compostela, La Coruña, Spain, 15702