AcneNCT05486910
Management of Side-Effects of Anti-Acne Treatment by a Cosmetic Routine
An observational study of Acne, run by Cosmetique Active International at 1 site in Poland.
Trial summary
Retinoid-based topical acne treatment may induce local tolerance issues such as erythema, dryness, stinging and burning sensations that may reduce adherence and efficacy. The tested regimen (cream and cleanser) has been specifically developed to rebalance the skin microbiome and compensate side-effects of topical… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne
- How many people
- 44 participants
- Where
- 1 sitePoland
- Study dates
- 29 Apr 2021to 29 Jul 2021
- Phase
- Observational
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: participants with a failed anti-acne routine meeting the inclusion and exclusion criteria and agreeing to the study constraints
Who may be able to join
- Caucasian;
- phototype I to IV
- subject under EPIDUO® with a failed cosmetic routine for more than 1 month.
- subject agreeing to change their routine (introduction of the EFFACLAR routine).
- subjects with moderate skin sensitivity: composite score >2 at the inclusion (burning sensation, tightness and itching) with 4 grades: absent, slight, medium and severe
- subject under anti-acne treatment since 1 month, with an usual routine in failure
- subject who presents irritated skin due to EPIDUO® treatment
Who cannot join
- pregnant or nursing woman or woman planning a pregnancy during the study
- cutaneous pathology on the studied zone other than acne (eczema etc.)
- use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability of the study product (according to the investigator's appreciation, except the anti-acne treatment Epiduo and former cosmetic routine)
- oral treatment of retinoids during the six previous months of the study
- any change in hormonal treatment (including contraceptive) during the three previous months of the study or subject under Androcur® generic) treatments since less than six months
- professional facial care during the study or within the previous month
- subject manipulating her/ his acne lesions
- excessive exposure to sunlight or UV-rays within the previous month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Management of Side-Effects of Anti-Acne Treatment by a Cosmetic Routine Following Failure of the Usual Cosmetic Routine
Retinoid-based topical acne treatment may induce local tolerance issues such as erythema, dryness, stinging and burning sensations that may reduce adherence and efficacy.
The tested regimen (cream and cleanser) has been specifically developed to rebalance the skin microbiome and compensate side-effects of topical treatments (hydration, skin barrier repair) together with an action on skin imperfections and marks.
This open-label study was conducted in subjects aged 12 years and over with sensitive skin (>2 on a sensitivity composite score from 0-3) treated for at least one month with the fixed-dose gel combination and presenting with treatment-related skin intolerance.
Read the detailed description
The study on the evaluation of the management of side-effects of an anti-acne treatment by a cosmetic routine (cleanser and cream) following failure of the usual cosmetic routine has been conducted under dermatological control by Dermscan that is certified by the International Standards Organization (ISO) 9001-2015.
Each study report is subjected to a quality inspection by a proofreader member of Dermscan not involved in the audited study. The inspection of the study report allows to confirm that the results reflect exactly the study raw data and that the study fulfills any standard and regulatory requirements.
Regarding the statistical analysis, data obtained for each parameter, at each measurement time and on each zone are presented in raw value tables. The tables also show the descriptive statistics: means, medians, minima, maxima, standard errors of the means (SEM), confidence intervals of 95% (CI 95%) of these values as well as the variations and percentage variations. They also present the results of the statistical analysis.
Participants have the right to exit from the study at any time and for any motive in compliance with the Helsinki Declaration (1964) and its successive updates. The investigator can also interrupt the subject participation in the study prematurely in the case of a disease occurrence, a pregnancy or the occurrence of an adverse reaction.
The personnel in charge of the study collects data into individual case report forms in electronic or paper format and/or directly from measurement software. When information is collected in paper format, the double data entry is then done from these supports by the designed operator(s), without any interpretation, in specific EXCEL databases. The Project Manager or assistant checks the double data entry by comparing both databases. Then the coherence of the whole data set is checked as well as formulas used in the EXCEL tables (calculation formulas, selected data…). When all the controls are done, the database is locked.
- Conditions
- Acne
- Keywords
- acne, efficacy, tolerance, dermocosmetic, quality of life
- Medical subject headings
- Acne Vulgaris
What is being measured
The primary outcome is the main question the study is designed to answer.
change in comedogenic potential
counting of retentional and inflammatory elements on the whole face. Descriptive statistics are done in order to determine the variation significance.
Measured: from baseline to Day28
change in Global Evaluation Acne (GEA) score
The dermatologist realizes clinical score on the face using the Investigator Global Acne Severity Score : from 0 Clear. No lesions to 5 Very severe.
Measured: from baseline to Day28
Secondary outcomes (7)
change in sensitivity score by the dermatologist
evaluation of the parameters erythema, dryness, desquamation on a 0-3 scale
Measured: from baseline to Day28
change in sensitivity score by the participant (composite score)
evaluation of the parameters itching, tightness, burning sensation on a 0-3 scale
Measured: from baseline to Day28
change in global tolerance score by the dermatologist
evaluation of the tolerance on a 0-3 scale
Measured: from baseline to Day28
change in global tolerance score by the participant
evaluation of the tolerance on a 0-3 scale
Measured: from baseline to Day28
change in overall effectiveness score by the dermatologist
evaluation of the effectiveness on a 0-3 scale
Measured: from baseline to Day28
change in overall effectiveness score by the participant
evaluation of the effectiveness on a 0-3 scale
Measured: from baseline to Day28
change in quality of life
Cardiff Acne Disability Index (CADI) questionnaire with 5 questions
Measured: from baseline to Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start29 Apr 2021
- Primary completion29 Jul 2021
- Study completion29 Jul 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Czermanska, Study director, Eurofins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486910
- Sponsor's protocol ID
- LRP20026-EFFACLAR SENSIBIOME
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Management of Side-Effects of Anti-Acne Treatment by a Cosmetic Routine Following Failure of the Usual Cosmetic Routine
- ClinicalTrials.gov ID
- NCT05486910
- Acronym / sponsor ID
- LRP20026-EFFACLAR SENSIBIOME
- Conditions
- Acne
- Keywords
- acne, efficacy, tolerance, dermocosmetic, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 4 Aug 2022 (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.
Retinoid-based topical acne treatment may induce local tolerance issues such as erythema, dryness, stinging and burning sensations that may reduce adherence and efficacy.
The tested regimen (cream and cleanser) has been specifically developed to rebalance the skin microbiome and compensate side-effects of topical treatments (hydration, skin barrier repair) together with an action on skin imperfections and marks.
This open-label study was conducted in subjects aged 12 years and over with sensitive skin (>2 on a sensitivity composite score from 0-3) treated for at least one month with the fixed-dose gel combination and presenting with treatment-related skin intolerance.
Detailed description
The study on the evaluation of the management of side-effects of an anti-acne treatment by a cosmetic routine (cleanser and cream) following failure of the usual cosmetic routine has been conducted under dermatological control by Dermscan that is certified by the International Standards Organization (ISO) 9001-2015.
Each study report is subjected to a quality inspection by a proofreader member of Dermscan not involved in the audited study. The inspection of the study report allows to confirm that the results reflect exactly the study raw data and that the study fulfills any standard and regulatory requirements.
Regarding the statistical analysis, data obtained for each parameter, at each measurement time and on each zone are presented in raw value tables. The tables also show the descriptive statistics: means, medians, minima, maxima, standard errors of the means (SEM), confidence intervals of 95% (CI 95%) of these values as well as the variations and percentage variations. They also present the results of the statistical analysis.
Participants have the right to exit from the study at any time and for any motive in compliance with the Helsinki Declaration (1964) and its successive updates. The investigator can also interrupt the subject participation in the study prematurely in the case of a disease occurrence, a pregnancy or the occurrence of an adverse reaction.
The personnel in charge of the study collects data into individual case report forms in electronic or paper format and/or directly from measurement software. When information is collected in paper format, the double data entry is then done from these supports by the designed operator(s), without any interpretation, in specific EXCEL databases. The Project Manager or assistant checks the double data entry by comparing both databases. Then the coherence of the whole data set is checked as well as formulas used in the EXCEL tables (calculation formulas, selected data…). When all the controls are done, the database is locked.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- participants with a failed anti-acne routine meeting the inclusion and exclusion criteria and agreeing to the study constraints
Key inclusion criteria (7 listed)
- Caucasian;
- phototype I to IV
- subject under EPIDUO® with a failed cosmetic routine for more than 1 month.
- subject agreeing to change their routine (introduction of the EFFACLAR routine).
- subjects with moderate skin sensitivity: composite score >2 at the inclusion (burning sensation, tightness and itching) with 4 grades: absent, slight, medium and severe
Key exclusion criteria (8 listed)
- pregnant or nursing woman or woman planning a pregnancy during the study
- cutaneous pathology on the studied zone other than acne (eczema etc.)
- oral treatment of retinoids during the six previous months of the study
- any change in hormonal treatment (including contraceptive) during the three previous months of the study or subject under Androcur® generic) treatments since less than six months
- professional facial care during the study or within the previous month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in comedogenic potential
Time frame: from baseline to Day28
counting of retentional and inflammatory elements on the whole face. Descriptive statistics are done in order to determine the variation significance.
change in Global Evaluation Acne (GEA) score
Time frame: from baseline to Day28
The dermatologist realizes clinical score on the face using the Investigator Global Acne Severity Score : from 0 Clear. No lesions to 5 Very severe.
7 secondary outcomes
change in sensitivity score by the dermatologist
Time frame: from baseline to Day28
change in sensitivity score by the participant (composite score)
Time frame: from baseline to Day28
change in global tolerance score by the dermatologist
Time frame: from baseline to Day28
change in global tolerance score by the participant
Time frame: from baseline to Day28
change in overall effectiveness score by the dermatologist
Time frame: from baseline to Day28
change in overall effectiveness score by the participant
Time frame: from baseline to Day28
change in quality of life
Time frame: from baseline to Day28
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 4 Aug 2022.
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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.
Anna Czermanska study director
Eurofins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne, run by Cosmetique Active International at 1 site in Poland.
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 8 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 4 Aug 2022. 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 Poland. 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?
change in comedogenic potential (time frame: from baseline to Day28). The study lists 2 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 4 Aug 2022.