Safety Evaluation of SS-POR11

Tolerability of a Topical Dermo-cosmetic Product in Acne-prone Subjects

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].

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Other: SS-POR11

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Westmount, Quebec, Canada
      • Klynical Consulting & Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11	Frequency of AEs and SAEs	Baseline
Signs of intolerance associated with the topical use of SS-POR11	Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test	Week 2
Subject sensitivity to SS-POR11	Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test.	Baseline
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11	Frequency of AEs and SAEs	Week 2
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11	Frequency of AEs and SAEs	Week 4
Signs of intolerance associated with the topical use of SS-POR11	Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Porphyrin distribution	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	Week 2, Week 4
Investigator Global Assessment (IGA)	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).	Week 2, Week 4

Collaborators and Investigators

• Sponsor: Klynical Consulting & Services
• Investigators: Study Director: Kaitlyn Enright, Klynical Consulting & Services

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 12, 2021
• Primary Completion (ACTUAL): August 18, 2021
• Study Completion (ACTUAL): August 18, 2021

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (ACTUAL): May 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SS-POR11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No