This study evaluates the efficiency of a probiotic as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. Half of the patients will receive the probiotic per os, while the other half will receive a placebo; all patients will continue with their regular psoriasis treatment.
The aim of this study is to evaluate the efficiency of a probiotic in capsules as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. The efficiency is measured as the reduction in the PASI score in the patients (18 to 70 years old) included in the study, with a mild to moderate plaque psoriasis treated exclusively with topic treatment in the moment of being included in the study. Apart from the PASI score reduction from the first visit to the end of the study, the ability to reduce the improvement time in those patients will be evaluated as well. Additionally, the following markers of systemic inflammation are also compared between both active and placebo branches: Tumor necrosis factor, Interferon-gamma, interleukines 1b, 12, 16 and 23.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
98
one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments)
one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments)
Centro Dermatológico Estético de Alicante
Alicante, Alicante, Spain
Number of patients with a PASI score reduction higher than 75%
Number of patients with a PASI score reduction higher than 75% from the basal value
Time frame: twelve weeks
Time to reach a reduction in the PASI score higher than 75%
time to reach a reduction in the PASI score higher than 75% in from the basal value
Time frame: twelve weeks
Average time to reach the clinical remission
Average time to reach the clinical remission, with no activity (PASI score lower than 6) from the treatment beginning
Time frame: twelve weeks
Differences among any of the inflammation markers
Time frame: twelve weeks
number of patients that remains in analytical remission
number of patients that remains in analytical remission (that is, that maintain said inflammation markers in normal values)
Time frame: twelve weeks
Number of patients with mild, moderate or severe adverse events
Number of patients with mild, moderate or severe adverse events attributable to regular treatment to psoriasis or to probiotic.
Time frame: twelve weeks
Number of patients with an improvement in the PGA score
Number of patients with an improvement in the PGA score at the end of the study with regard of basal values
Time frame: Twelve weeks
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