An observational study in Acne, sponsored by Cosmetique Active International. Completed at 1 site in Poland. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-04.
Sponsored by Cosmetique Active International · Observational
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.
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.
731 studies on the registry are indexed under Acne Vulgaris; 87 are open to participants now.
This study's enrollment of 44 is below the median of 90 across 81 observational studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Cosmetique Active International is the lead sponsor of 54 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
participants with a failed anti-acne routine meeting the inclusion and exclusion criteria and agreeing to the study constraints
Exclusion Criteria:
cutaneous pathology on the studied zone other than acne (eczema etc.)
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.
Time frame: 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.
Time frame: from baseline to Day28
change in sensitivity score by the dermatologist
evaluation of the parameters erythema, dryness, desquamation on a 0-3 scale
Time frame: 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
Time frame: from baseline to Day28
change in global tolerance score by the dermatologist
evaluation of the tolerance on a 0-3 scale
Time frame: from baseline to Day28
change in global tolerance score by the participant
evaluation of the tolerance on a 0-3 scale
Time frame: from baseline to Day28
change in overall effectiveness score by the dermatologist
evaluation of the effectiveness on a 0-3 scale
Time frame: from baseline to Day28
change in overall effectiveness score by the participant
evaluation of the effectiveness on a 0-3 scale
Time frame: from baseline to Day28
change in quality of life
Cardiff Acne Disability Index (CADI) questionnaire with 5 questions
Time frame: from baseline to Day28
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Cosmetique Active International