Safety Evaluation of SS-POR11
Study Details
Study Description
Brief Summary
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].
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11 [Baseline]
Frequency of AEs and SAEs
- Signs of intolerance associated with the topical use of SS-POR11 [Week 2]
Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test
- Subject sensitivity to SS-POR11 [Baseline]
Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test.
- Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11 [Week 2]
Frequency of AEs and SAEs
- Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11 [Week 4]
Frequency of AEs and SAEs
- Signs of intolerance associated with the topical use of SS-POR11 [Week 4]
Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test
Secondary Outcome Measures
- Porphyrin distribution [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
- Investigator Global Assessment (IGA) [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant's first language of French or English, given the written language of the ICF
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Participants willing to sign the ICF upon entering the study
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Participant must be willing and able (in the PI's opinion) to comply with all study requirements
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Participant must be aged 18-40 years
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Participant must have a screening and baseline IGA score of 1 (rare blemishes/clear skin) or 2-3 (mild to moderate facial acne vulgaris)
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Participant must agree to appear on all evaluation days and conform to all study-related instructions
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Participant must agree not to undergo any topical treatments in the areas under investigation during the study period
Exclusion Criteria:
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Participants under the age of 18 years or over the age of 40
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Refusal to sign the ICF
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Participants has any injuries or tumors in the areas under investigation
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Participant has a recent (i.e., 3 months) surgery or invasive treatment in the areas under investigation
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Use of oral antibiotics within 4 weeks prior to start of study
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Use of oral or topical "probiotic" products within one month prior to start of study
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Prior (3 months) or planned use of chemical peels, microdermabrasion, microneedling, or exfoliants during the course of the study
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Participant is using or has used within 3 months drugs such as corticosteroids, immunosuppressants, or others collagen-production inhibitors
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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)
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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
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Participant has immunocompromising diseases; any known allergy or hypersensitivity to any of the ingredients of the investigational product
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Participants possessing any of the contraindications for use of SS-POR11
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Participant has tattoos, piercings, excessive scarring (e.g., hypertrophic or keloid scars) in the areas under investigation
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klynical Consulting & Services | Westmount | Quebec | Canada |
Sponsors and Collaborators
- Klynical Consulting & Services
Investigators
- Study Director: Kaitlyn Enright, Klynical Consulting & Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SS-POR11