Safety Evaluation of SS-POR11

Klynical Consulting & Services

Status

Completed

Conditions

Acne

Treatments

Other: SS-POR11

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT04905368

SS-POR11

Details and patient eligibility

About

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].

Enrollment

20 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.