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: * Number of values * Mean * Median * Standard deviation (SD) * Minimum value * Maximum value. Are summarized in frequency (N) and percentage (%) by time point: * the Investigator's Global Assessment (IGA) score assessed by the investigator using a 6-point scale * the soothing effect assessed by the subject using a 4-point scale for the parameters pain and pruritus * each global tolerance score assessed by the investigator and by the subject using a 4-point scale. 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.
Study Type
OBSERVATIONAL
Enrollment
109
EUROFINS CRL, Inc.
Piscataway, New Jersey, United States
EUROFINS CONSUMER PRODUCT TESTING Co. Ltd
Guangzhou, China
Insight Research
Quatre Bornes, Mauritius
EUROFINS DERMSCAN POLAND Sp.
Gdansk, Poland
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
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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