Evaluation of Cicaplast in Subjects With Skin Irritation

NCT ID: NCT05767333

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2022-06-06

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.

Conditions

Skin Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cosmetique Active International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Le Floc'h

Role: STUDY_DIRECTOR

Cosmetique Active International

Locations

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

Countries

United States; China; Mauritius; Poland

Other Identifiers

LRP21005-CICAPLAST BAUME B5

Identifier Type: -

Identifier Source: org_study_id