Clinical trial NCT04905368: Safety Evaluation of SS-POR11
Official title: Tolerability of a Topical Dermo-cosmetic Product in Acne-prone Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Lead sponsor: Klynical Consulting & Services
Sponsor class: NETWORK
First posted: 2021-05-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 \[Investigator's Global Assessment (IGA) 1-3\].


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
timeFrame: Baseline
measure: Signs of intolerance associated with the topical use of SS-POR11
timeFrame: Week 2
measure: Subject sensitivity to SS-POR11
timeFrame: Baseline
measure: Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
timeFrame: Week 2
measure: Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
timeFrame: Week 4
measure: Signs of intolerance associated with the topical use of SS-POR11
timeFrame: Week 4
Secondary outcomes:
measure: Porphyrin distribution
timeFrame: Week 2, Week 4
measure: Investigator Global Assessment (IGA)
timeFrame: Week 2, Week 4
Other outcomes:
Locations:
city: Westmount
country: Canada
facility: Klynical Consulting & Services
state: Quebec
Study officials:
affiliation: Klynical Consulting & Services
name: Kaitlyn Enright
role: STUDY_DIRECTOR
References: