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NCT05767333 | COMPLETED | Skin Diseases

Evaluation of Cicaplast in Subjects With Skin Irritation

Active Cosmetics 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).

Condition or disease

Skin Diseases

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.

Estimated Enrollment : 109 participants
Official Title : Evaluation of Cicaplast in Subjects With Skin Irritation for 21 Days
Actual Study Start Date : 2021-10-11
Estimated Primary Completion Date : 2022-06-06
Estimated Study Completion Date : 2022-06-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 3 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

Evaluation of Cicaplast in Subjects With Skin Irritation

Location Details


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Not yet recruiting

United States, New Jersey


Piscataway, New Jersey, United States, 08854

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Guangzhou, China,

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Insight Research

Quatre Bornes, Mauritius,

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Gdańsk, Poland,