Evaluation of Cicaplast in Subjects With Skin Irritation
Study Details
Study Description
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).
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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:
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Number of values
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Mean
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Median
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Standard deviation (SD)
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Minimum value
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Maximum value.
Are summarized in frequency (N) and percentage (%) by time point:
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the Investigator's Global Assessment (IGA) score assessed by the investigator using a 6-point scale
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the soothing effect assessed by the subject using a 4-point scale for the parameters pain and pruritus
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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 investigator [from baseline to Day21]
the investigator evaluates the global tolerance using a 4-point scale (from 0=null to 3= excellent)
- 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 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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), ...
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localization of irritation lesions: face, limbs, trunk, feet, fold, hands, ...
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subjects having a feeling of discomfort at the site of the lesion.
Exclusion Criteria:
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cutaneous pathology on the studied zone (other than the required irritations)
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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);
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subject with healing disorder (keloid, hypertrophic)
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subject with Type 1 diabetic
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subject under chemotherapy and radiotherapy
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subject with a skin disease on evaluation site: psoriasis and atopic dermatitis active lesions and hand dermatitis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | EUROFINS CRL, Inc. | Piscataway | New Jersey | United States | 08854 |
| 2 | EUROFINS CONSUMER PRODUCT TESTING Co. Ltd | Guangzhou | China | ||
| 3 | Insight Research | Quatre Bornes | Mauritius | ||
| 4 | EUROFINS DERMSCAN POLAND Sp. | Gdańsk | Poland |
Sponsors and Collaborators
- Cosmetique Active International
Investigators
- Study Director: Caroline Le Floc'h, Cosmetique Active International
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LRP21005-CICAPLAST BAUME B5