Satisfaction Survey - Cicaplast Mains

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.

Study Overview

• Status: Completed
• Conditions: Hand Eczema; Hand Dermatoses

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 Type: Observational
• Enrollment (Actual): 380

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Dermatology practices
• Poland
  • Warsaw, Poland
    • Dermatology practices
• Slovenia
  • Ljubljana, Slovenia
    • Dermatology practices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population corresponds to hairdressing professionals who are in permanent contact with irritating products (e.g. shampoos, hair colorants, oxidants, ...).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
satisfaction rate	satisfaction questionnaire with a 5-point scale	from baseline to Day28

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cosmetique Active International

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2014
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (ACTUAL): July 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hand Dermatoses
• Other Study ID Numbers: LRP14011-CICAPLAST BAUME B5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No