Safety Evaluation of SS-POR11

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905368
• Other study ID #: SS-POR11
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: August 18, 2021

Study information

• Verified date: September 2021
• Source: Klynical Consulting & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 18, 2021
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne

Intervention

Other:
• SS-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.

Locations

Country	Name	City	State
Canada	Klynical Consulting & Services	Westmount	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Klynical Consulting & Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11	Frequency of AEs and SAEs	Baseline
Primary	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
Primary	Subject sensitivity to SS-POR11	Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test.	Baseline
Primary	Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11	Frequency of AEs and SAEs	Week 2
Primary	Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11	Frequency of AEs and SAEs	Week 4
Primary	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	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
Secondary	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