The purpose of this study is to evaluate the safety and efficacy of the KLOX Biophotonic System in patients with moderate to severe facial acne vulgaris using a split-face design (treated hemiface vs untreated hemiface).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
KLOX Biophotonic System (KLOX KLGA0105-01 photo-converter gel and KLOX THERA lamp) will be administered twice a week for 6 weeks followed by a 6-week follow up period
Attikon University General Hospital
Athens, Greece
Andreas Sygros Hospital
Athens, Greece
Papageorgiou Hospital
Thessaloniki, Greece
Proportion of patients achieving a total reduction of at least 2 grades in the Investigator's Global Assessment (IGA) scale
Time frame: 12 weeks
Reduction in inflammatory lesions
Time frame: 6 and 12 weeks
Proportion of patients achieving a reduction of at least 1 grade in the Investigator's Global Assessment (IGA) scale
Time frame: 6 and 12 weeks
Proportion of patients achieving a reduction to grade 1 or 0 in the Investigator's Global Assessment (IGA) scale
Time frame: 6 and 12 weeks
Patient satisfaction questionnaire
Time frame: 6 and 12 weeks
Pain assessment using a visual analogue scale
Time frame: 12 weeks
Safety evaluations (treatment-emergent and treatment related adverse events)
Time frame: 12 weeks
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