Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT05471934
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:
NCT05471934
Study Brief:
Protocol Section:
NCT05471934