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CompletedNCT05471934Updated Jul 25, 2022

Satisfaction Survey - Cicaplast Mains

An observational study in Hand Eczema and Hand Dermatoses, sponsored by Cosmetique Active International. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-25.

Sponsored by Cosmetique Active International · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
380
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hand Eczema
  • Hand Dermatoses

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03

In context

Skin Diseases

538 studies on the registry are indexed under Skin Diseases; 92 are open to participants now.

This study's enrollment of 380 is above the median of 168 across 147 observational studies indexed under Skin Diseases.

Browse Skin Diseases studies →

Lead sponsor

Cosmetique Active International is the lead sponsor of 54 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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, ...).

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

Exclusion Criteria:

  • professionals that do not meet the inclusion criteria
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
380 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. satisfaction rate

    satisfaction questionnaire with a 5-point scale

    Time frame: from baseline to Day28

Secondary outcomes

  1. evaluation of hands problems (dryness, redness, irritations, cracks, fissures)

    evaluation on a 10-point scale (0 Not at all to 10 Very strong)

    Time frame: from baseline to Day28

07

Study locations

3 sites
  • Dermatology practices
    Roma, Italy
  • Dermatology practices
    Warsaw, Poland
  • Dermatology practices
    Ljubljana, Slovenia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05471934
Lead sponsor
Cosmetique Active International
Responsible party
Sponsor
First posted
Jul 25, 2022
Start date
Feb 2014
Primary completion
May 2014
Completion
May 2014
Last update
Jul 25, 2022

Study contacts

Delphine Kerob
study director · Cosmetique Active International

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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