Safety Evaluation of SS-POR11

NCT04905368 | Completed

• 1 other identifier: SS-POR11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Acne

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Porphyrin distribution

  Week 2, Week 4

• Investigator Global Assessment (IGA)

  Week 2, Week 4

Interventions

SS-POR11 OTHER

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Klynical Consulting & Services: lead

Study Sites (1)

Klynical Consulting & Services

Westmount, Quebec, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Kaitlyn Enright

  Klynical Consulting & Services

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 27, 2021
• Study Start: May 12, 2021
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)