Evaluation of Cicaplast in Subjects With Skin Irritation

Completed

• Conditions: Skin Diseases

• Registration Number: NCT05767333
• Lead Sponsor: Cosmetique Active International

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.

Study Timeline

• Study Start: 2021-10-11
• Primary Completion: 2022-06-06
• Study Completion: 2022-06-06
• Status Verified: 2023-03
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study First Posted: 2023-03-14
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evaluation of the effect on the recovery of irritated skin lesions	from baseline to Day21	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)

Secondary Outcome Measures

Name	Time	Method
evaluation of the local signs of irritated area	from baseline to Day21	the investigator assesses the local signs (erythema, desquamation, pigmentation, cracks, oedema) using a 4-point scale (from absent to severe)
evaluation of the skin sensitivity	from baseline to Day21	the patient evaluates the sensitivity of irritated areas using a 4-point scale for pain and pruritus ((from 0= absent to 3= severe)
evaluation of the global tolerance by the patient	from baseline to Day21	the patient evaluates the global tolerance using a 4-point scale (from 0=null to 3= excellent)
evaluation of the anti-irritating effect	from baseline to Day21	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.
evaluation of the global tolerance by the investigator	from baseline to Day21	the investigator evaluates the global tolerance using a 4-point scale (from 0=null to 3= excellent)
evaluation of post-recovery marks	Day21	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
evaluation of the global effect by the investigator	Day21	the investigator evaluates the global effect using a 5-point scale (from -1= worsening to 3= excellent)
evaluation of the global effect by the patient	Day21	the patient evaluates the global effect using a 5-point scale (from -1= worsening to 3= excellent)

Trial Locations

Locations (4)

EUROFINS CRL, Inc.; 🇺🇸 Piscataway, New Jersey, United States

Insight Research; 🇲🇺 Quatre Bornes, Mauritius

EUROFINS CONSUMER PRODUCT TESTING Co. Ltd; 🇨🇳 Guangzhou, China

EUROFINS DERMSCAN POLAND Sp.; 🇵🇱 Gdańsk, Poland