Klynical Consulting & Services
Westmount, Quebec, Canada
NCT Number: NCT04905368
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].
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Westmount, Quebec, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline
Frequency of AEs and SAEs
Time frame: Week 2
Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test
Time frame: Baseline
Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test.
Time frame: Week 2
Frequency of AEs and SAEs
Time frame: Week 4
Frequency of AEs and SAEs
Time frame: Week 4
Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test
Time frame: Week 2, Week 4
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
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).
Klynical Consulting & Services
Network
Tolerability of a Topical Dermo-cosmetic Product in Acne-prone Subjects
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