Satisfaction Survey - Cicaplast Mains

Hand Eczema Clinical Trial

Official title:

Satisfaction Survey - Cicaplast Mains

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05471934
• Other study ID #: LRP14011-CICAPLAST BAUME B5
• Status: Completed
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: July 2022
• Source: Cosmetique Active International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hand Dermatoses
• Hand Eczema
• Skin Diseases

Locations

Country	Name	City	State
Italy	Dermatology practices	Roma
Poland	Dermatology practices	Warsaw
Slovenia	Dermatology practices	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Countries where clinical trial is conducted

Italy,  Poland,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	satisfaction rate	satisfaction questionnaire with a 5-point scale	from baseline to Day28
Secondary	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