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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SS-POR11 | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11 | Frequency of AEs and SAEs | Baseline |
| Signs of intolerance associated with the topical use of SS-POR11 | Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test | Week 2 |
| Subject sensitivity to SS-POR11 | Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test. | Baseline |
| Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11 | Frequency of AEs and SAEs | Week 2 |
| Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11 | Frequency of AEs and SAEs | 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 | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 2, Week 4 |
| Investigator Global Assessment (IGA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaitlyn Enright | Klynical Consulting & Services | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klynical Consulting & Services | Westmount | Quebec | Canada |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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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).
| Week 2, Week 4 |