Evaluation of Cicaplast in Subjects With Skin Irritation

Skin Diseases Clinical Trial

Official title:

Evaluation of Cicaplast in Subjects With Skin Irritation for 21 Days

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05767333
• Other study ID #: LRP21005-CICAPLAST BAUME B5
• Status: Completed
• Start date: October 11, 2021
• Est. completion date: June 6, 2022

Study information

• Verified date: March 2023
• Source: Cosmetique Active International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Diseases

Locations

Country	Name	City	State
China	EUROFINS CONSUMER PRODUCT TESTING Co. Ltd	Guangzhou
Mauritius	Insight Research	Quatre Bornes
Poland	EUROFINS DERMSCAN POLAND Sp.	Gdansk
United States	EUROFINS CRL, Inc.	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Countries where clinical trial is conducted

United States,  China,  Mauritius,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	from baseline to Day21
Secondary	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.	from baseline to Day21
Secondary	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)	from baseline to Day21
Secondary	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)	from baseline to Day21
Secondary	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)	from baseline to Day21
Secondary	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	Day21
Secondary	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)	Day21
Secondary	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)	Day21