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Completed

NCT Number: NCT04905368

Safety Evaluation of SS-POR11

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].

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klynical Consulting & Services

Westmount, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11

    Time frame: Baseline

    Frequency of AEs and SAEs

  2. Signs of intolerance associated with the topical use of SS-POR11

    Time frame: Week 2

    Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test

  3. Subject sensitivity to SS-POR11

    Time frame: Baseline

    Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test.

  4. Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11

    Time frame: Week 2

    Frequency of AEs and SAEs

  5. Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11

    Time frame: Week 4

    Frequency of AEs and SAEs

  6. Signs of intolerance associated with the topical use of SS-POR11

    Time frame: Week 4

    Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test

Secondary outcomes

  1. Porphyrin distribution

    Time frame: 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

  2. Investigator Global Assessment (IGA)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Klynical Consulting & Services

Network

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 27, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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