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OpenTrials
Completed

NCT Number: NCT05471934

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.

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Key information

Conditions

Hand Eczema Hand Dermatoses Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dermatology practices, Roma, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. satisfaction rate

    Time frame: from baseline to Day28

    satisfaction questionnaire with a 5-point scale

Secondary outcomes

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

    Time frame: from baseline to Day28

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

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 25, 2022
Registry last updated
Jul 25, 2022

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.

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