Evaluation of Cicaplast in Subjects With Skin Irritation

NCT05767333 | Completed

• 1 other identifier: LRP21005-CICAPLAST BAUME B5
• Study Type: observational
• Target: 109
• Locations: 4 countries
• Sites: 4

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).

Conditions

Skin Diseases

Keywords

skin irritation; irritative dermatitis; superficial burn

Outcome Measures

Primary Outcomes (1)

• 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)

  from baseline to Day21

Secondary Outcomes (8)

• evaluation of the local signs of irritated area

  from baseline to Day21

• evaluation of the anti-irritating effect

  from baseline to Day21

• evaluation of the skin sensitivity

  from baseline to Day21

• evaluation of the global tolerance by the investigator

  from baseline to Day21

• evaluation of the global tolerance by the patient

  from baseline to Day21

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (4)

EUROFINS CRL, Inc.

Piscataway, New Jersey, 08854, United States

Location

EUROFINS CONSUMER PRODUCT TESTING Co. Ltd

Guangzhou, China

Location

Insight Research

Quatre Bornes, Mauritius

Location

EUROFINS DERMSCAN POLAND Sp.

Gdansk, Poland

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Caroline Le Floc'h

  Cosmetique Active International

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: October 11, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

CN (1); US (1); MA (1); PL (1)