Clinical trial NCT05767333: Evaluation of Cicaplast in Subjects With Skin Irritation
Official title: Evaluation of Cicaplast in Subjects With Skin Irritation for 21 Days
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Diseases
Keywords: skin irritation
irritative dermatitis
superficial burn
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2023-03-14
Enrollment: 109
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults, teens and children meeting the inclusion and exclusion criteria and willing to adhere to the protocol and study procedures

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* subjects presenting the following skin irritations (at least 3 to 5 per irritation): irritative and cracked dermatitis, dry eczematids/dry patches, rubbing irritation in specific location (ex: thumb frictions, lichenifications), ...
* localization of irritation lesions: face, limbs, trunk, feet, fold, hands, ...
* subjects having a feeling of discomfort at the site of the lesion.

Exclusion Criteria:

* cutaneous pathology on the studied zone (other than the required irritations)
* 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);
* subject with healing disorder (keloid, hypertrophic)
* subject with Type 1 diabetic
* subject under chemotherapy and radiotherapy
* subject with a skin disease on evaluation site: psoriasis and atopic dermatitis active lesions and hand dermatitis

Primary outcomes:
measure: evaluation of the effect on the recovery of irritated skin lesions
timeFrame: from baseline to Day21
Secondary outcomes:
measure: evaluation of the local signs of irritated area
timeFrame: from baseline to Day21
measure: evaluation of the anti-irritating effect
timeFrame: from baseline to Day21
measure: evaluation of the skin sensitivity
timeFrame: from baseline to Day21
measure: evaluation of the global tolerance by the investigator
timeFrame: from baseline to Day21
measure: evaluation of the global tolerance by the patient
timeFrame: from baseline to Day21
measure: evaluation of post-recovery marks
timeFrame: Day21
measure: evaluation of the global effect by the investigator
timeFrame: Day21
measure: evaluation of the global effect by the patient
timeFrame: Day21
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: EUROFINS CRL, Inc.
state: New Jersey
city: Guangzhou
country: China
facility: EUROFINS CONSUMER PRODUCT TESTING Co. Ltd
city: Quatre Bornes
country: Mauritius
facility: Insight Research
city: Gdańsk
country: Poland
facility: EUROFINS DERMSCAN POLAND Sp.
Study officials:
affiliation: Cosmetique Active International
name: Caroline Le Floc'h
role: STUDY_DIRECTOR
References: