Safety Evaluation of SS-POR11
- Conditions
- Acne
- Registration Number
- NCT04905368
- Lead Sponsor
- Klynical Consulting & Services
- 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 \[Investigator's Global Assessment (IGA) 1-3\].
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11 Week 4 Frequency of AEs and SAEs
Subject sensitivity to SS-POR11 Baseline Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test.
- Secondary Outcome Measures
Name Time Method 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 distributionInvestigator 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).
Trial Locations
- Locations (1)
Klynical Consulting & Services
🇨🇦Westmount, Quebec, Canada