The goal of the present study is to assess the safety of a topical probiotic (probiotic strain; SS-POR11) on acne prone-skin, and the impact of SS-POR11 on the distribution of porphyrins, in subjects with mild-to-moderate acne \[Investigator's Global Assessment (IGA) 1-3\].
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Topical composition containing probiotic strains derived from human skin (SS-POR11). Participants will be instructed to apply it topically to face, twice weekly for the duration of the trial.
Klynical Consulting & Services
Westmount, Quebec, Canada
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
Frequency of AEs and SAEs
Time frame: Baseline
Signs of intolerance associated with the topical use of SS-POR11
Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test
Time frame: Week 2
Subject sensitivity to SS-POR11
Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test.
Time frame: Baseline
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
Frequency of AEs and SAEs
Time frame: Week 2
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
Frequency of AEs and SAEs
Time frame: Week 4
Signs of intolerance associated with the topical use of SS-POR11
Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test
Time frame: Week 4
Porphyrin distribution
Efficacy of SS-POR11 to reduce levels of porphyrins on the skin, as assessed by the VISIA® Skin Analysis System. Average percent change in facial porphyrin distribution
Time frame: Week 2, Week 4
Investigator Global Assessment (IGA)
Frequency of subjects displaying at least a one-point improvement on the IGA, at follow up visits compared to baseline. The IGA is an ordinal scale with five grades corresponding to increasing severities of acne (e.g., 0 to 4).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 2, Week 4