Safety Evaluation of SS-POR11

Study Overview
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Brief Summary
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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].

Official Title
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Tolerability of a Topical Dermo-cosmetic Product in Acne-prone Subjects

Conditions
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Acne

Intervention / Treatment
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* Other: SS-POR11


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant's first language of French or English, given the written language of the ICF Participants willing to sign the ICF upon entering the study Participant must be willing and able (in the PI's opinion) to comply with all study requirements Participant must be aged 18-40 years Participant must have a screening and baseline IGA score of 1 (rare blemishes/clear skin) or 2-3 (mild to moderate facial acne vulgaris) Participant must agree to appear on all evaluation days and conform to all study-related instructions Participant must agree not to undergo any topical treatments in the areas under investigation during the study period Exclusion Criteria: Participants under the age of 18 years or over the age of 40 Refusal to sign the ICF Participants has any injuries or tumors in the areas under investigation Participant has a recent (i.e., 3 months) surgery or invasive treatment in the areas under investigation Use of oral antibiotics within 4 weeks prior to start of study Use of oral or topical probiotic products within one month prior to start of study Prior (3 months) or planned use of chemical peels, microdermabrasion, microneedling, or exfoliants during the course of the study Participant is using or has used within 3 months drugs such as corticosteroids, immunosuppressants, or others collagen-production inhibitors Participant is pregnant or lactating or wishes to get pregnant within the next 3 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential) Participant has active herpes simplex in the investigated areas or a history of herpes labialis with four or more outbreaks in the 12 months prior to baseline Participant has immunocompromising diseases; any known allergy or hypersensitivity to any of the ingredients of the investigational product Participants possessing any of the contraindications for use of SS-POR11 Participant has tattoos, piercings, excessive scarring (e.g., hypertrophic or keloid scars) in the areas under investigation Current or prior (3 months) change in the use of retinoids; Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months; and any other criteria that at the discretion of the Investigator, could interfere with study assessments or expose the subject to undue risk by study participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: SS-POR11|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |