Acne
Conditions
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 \[Investigator's Global Assessment (IGA) 1-3\].
Interventions
OTHERSS-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.
Sponsors
Klynical Consulting & Services
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada
Outcome results
None listed