Status:
COMPLETED
Safety Evaluation of SS-POR11
Lead Sponsor:
Klynical Consulting & Services
Conditions:
Acne
Eligibility:
All Genders
18-40 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04905368
Start Date
May 12 2021
End Date
August 18 2021
Last Update
September 16 2021
Active Locations (1)
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1
Klynical Consulting & Services
Westmount, Quebec, Canada