An observational study in Skin Diseases, sponsored by Cosmetique Active International. Completed at 4 sites in 4 countries. Open to participants aged 3 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-14.
Sponsored by Cosmetique Active International (part of L'Oréal) · Observational
The aim of this open, before/after, multicentric study is to assess the effect and tolerance of Cicaplast Baume B5 in patients having a skin irritation (irritative and cracked dermatitis, dry eczematids, rubbing irritation, ...) under dermatological control. Patients are asked to apply the product at least twice a day until complete recovery (maximum 21 days).
Dermscan has implemented a quality management system which has been certified by the International Standards Organization (ISO 9001: 2015). This quality assurance system includes appropriate Good Clinical Practices (GCP) and regulation requirements. The proofreader is not involved in the audited study. A certificate of quality inspection signed by the person who checked the report is enclosed in each study.
Statistical method
Regarding the descriptive analysis, the quantitative data is summarized using the following statistics by time point:
Are summarized in frequency (N) and percentage (%) by time point:
The score of anti-irritating effect (SCOre de REparation de l'EPIderme= SCOREPI) is summarized using statistics for quantitative variables at each time point.
The local signs of irritated area assessed using a 4-point scale (erythema, desquamation, pigmentation, cracks, oedema) are summarized in frequency (N) and percentage (%) and by time point and by parameter.
496 studies on the registry are indexed under Skin Diseases; 77 are open to participants now.
This study's enrollment of 109 is below the median of 165 across 101 observational studies indexed under Skin Diseases.
Browse Skin Diseases studies →Cosmetique Active International is the lead sponsor of 55 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
adults, teens and children meeting the inclusion and exclusion criteria and willing to adhere to the protocol and study procedures
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
evaluation of the effect on the recovery of irritated skin lesions
the investigator evaluates the improvement of the tested product using the IGA score on a 6-point scale (from -1: aggravation to 4: complete recovery)
Time frame: from baseline to Day21
evaluation of the local signs of irritated area
the investigator assesses the local signs (erythema, desquamation, pigmentation, cracks, oedema) using a 4-point scale (from absent to severe)
Time frame: from baseline to Day21
evaluation of the anti-irritating effect
the investigator evaluates the lesions using SCOREPI tool which takes into account the following parameters: total surface of the skin lesions, erythema, desquamation, and cracks.
Time frame: from baseline to Day21
evaluation of the skin sensitivity
the patient evaluates the sensitivity of irritated areas using a 4-point scale for pain and pruritus ((from 0= absent to 3= severe)
Time frame: from baseline to Day21
evaluation of the global tolerance by the investigator
the investigator evaluates the global tolerance using a 4-point scale (from 0=null to 3= excellent)
Time frame: from baseline to Day21
evaluation of the global tolerance by the patient
the patient evaluates the global tolerance using a 4-point scale (from 0=null to 3= excellent)
Time frame: from baseline to Day21
evaluation of post-recovery marks
the investigator assesses post-recovery marks score concerning type (redness, hyperpigmentation, hypopigmentation) and severity using a 4-point scale (from 1= almost absent to 4= severe) of an irritated area
Time frame: Day21
evaluation of the global effect by the investigator
the investigator evaluates the global effect using a 5-point scale (from -1= worsening to 3= excellent)
Time frame: Day21
evaluation of the global effect by the patient
the patient evaluates the global effect using a 5-point scale (from -1= worsening to 3= excellent)
Time frame: Day21
Ran from Oct 2021 to primary completion in Jun 2022, 7 months.
Of 54 observational studies under Skin Diseases, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 250. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Cosmetique Active International →