Skip to main content
OpenTrials
Completed

NCT Number: NCT05767333

Evaluation of Cicaplast in Subjects With Skin Irritation

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Diseases Skin and Connective Tissue Diseases

Age range

3 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

EUROFINS CONSUMER PRODUCT TESTING Co. Ltd, Guangzhou, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. evaluation of the effect on the recovery of irritated skin lesions

    Time frame: 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 outcomes

  1. evaluation of the local signs of irritated area

    Time frame: from baseline to Day21

    the investigator assesses the local signs (erythema, desquamation, pigmentation, cracks, oedema) using a 4-point scale (from absent to severe)

  2. evaluation of the anti-irritating effect

    Time frame: 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.

  3. evaluation of the skin sensitivity

    Time frame: 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)

  4. evaluation of the global tolerance by the investigator

    Time frame: from baseline to Day21

    the investigator evaluates the global tolerance using a 4-point scale (from 0=null to 3= excellent)

  5. evaluation of the global tolerance by the patient

    Time frame: from baseline to Day21

    the patient evaluates the global tolerance using a 4-point scale (from 0=null to 3= excellent)

  6. evaluation of post-recovery marks

    Time frame: 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

  7. evaluation of the global effect by the investigator

    Time frame: Day21

    the investigator evaluates the global effect using a 5-point scale (from -1= worsening to 3= excellent)

  8. evaluation of the global effect by the patient

    Time frame: Day21

    the patient evaluates the global effect using a 5-point scale (from -1= worsening to 3= excellent)

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Official study title

Evaluation of Cicaplast in Subjects With Skin Irritation for 21 Days

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2023
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.