AcneNCT04905368
Safety Evaluation of SS-POR11
A study testing SS-POR11 in people with Acne, run by Klynical Consulting & Services at 1 site in Canada.
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]. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- SS-POR11
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 12 May 2021to 18 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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].
- Conditions
- Acne
- Being tested
- SS-POR11
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SS-POR11Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
Frequency of AEs and SAEs
Measured: Baseline
Signs of intolerance associated with the topical use of SS-POR11
Frequency of signs of intolerance, via evaluation of the Skin Tolerability Test
Measured: Week 2
Subject sensitivity to SS-POR11
Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test.
Measured: Baseline
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
Frequency of AEs and SAEs
Measured: Week 2
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
Frequency of AEs and SAEs
Measured: 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
Measured: Week 4
Secondary outcomes (2)
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
Measured: 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).
Measured: Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start12 May 2021
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klynical Consulting & Services
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Kaitlyn Enright, Study director, Klynical Consulting & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905368
- Sponsor's protocol ID
- SS-POR11
- Status last verified
- Sep 2021
- First submitted
- 18 May 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of a Topical Dermo-cosmetic Product in Acne-prone Subjects
- ClinicalTrials.gov ID
- NCT04905368
- Acronym / sponsor ID
- SS-POR11
- Conditions
- Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Klynical Consulting & ServicesResearch network
- Study start
- 12 May 2021 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SS-POR11Topical 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. | Other | – |
Primary outcome
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
Time frame: Baseline
Frequency of AEs and SAEs
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
Subject sensitivity to SS-POR11
Time frame: Baseline
Frequency of signs of sensitivity, via evaluation of the Skin Tolerability Test.
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
Time frame: Week 2
Frequency of AEs and SAEs
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11
Time frame: Week 4
Frequency of AEs and SAEs
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
2 secondary outcomes
Porphyrin distribution
Time frame: Week 2, Week 4
Investigator Global Assessment (IGA)
Time frame: Week 2, Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaitlyn Enright study director
Klynical Consulting & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SS-POR11 in people with Acne, run by Klynical Consulting & Services at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) and Serious AEs (SAEs) associated with the topical use of SS-POR11 (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.