Satisfaction Survey - Cicaplast Mains

Completed

• Conditions: Hand Dermatoses; Hand Eczema

• Registration Number: NCT05471934
• Lead Sponsor: Cosmetique Active International

Brief Summary

The participants presenting with hand problems and meeting the inclusion criteria are asked to apply the study product for one month. They are evaluated before and after treatment.

Detailed Description

The international, open, observational survey is conducted in 3 different countries.

Regarding the statistical analysis, the global satisfaction is described in 5 classes and in 2 classes "Satisfied + Very satisfied" vs. "Neither satisfied nor dissatisfied + Not so satisfied + Not at all satisfied". The 95% Confidence Interval (CI) of the percent of "Satisfied + Very satisfied" is also given.

On patients who already used cream at the inclusion, the following analyses are performed:

* Cross-tabulation between both visits,

* Test of the evolution between both visits using a special procedure for ordinal data with repeated measures,

* Description of a summary variable in 3 classes (Improved / No change / Worsened).

For the analysis of the hands problems, each sign is described at the inclusion and at the evaluation visit. The difference Evaluation-Inclusion is also given. The evolution of the sign is performed by a Wilcoxon test for matched samples.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2022-07
• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-22
• Last Update Submitted: 2022-07-22
• Study First Posted: 2022-07-25
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• professionals that work on different activities related to hair in a beauty salon
• professionals presenting with current hand problems such as dryness, redness, irritations, cracks and fissures

Exclusion Criteria

• professionals that do not meet the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
satisfaction rate	from baseline to Day28	satisfaction questionnaire with a 5-point scale

Secondary Outcome Measures

Name	Time	Method
evaluation of hands problems (dryness, redness, irritations, cracks, fissures)	from baseline to Day28	evaluation on a 10-point scale (0 Not at all to 10 Very strong)

Trial Locations

Locations (1)

Dermatology practices; 🇸🇮 Ljubljana, Slovenia