Hand EczemaNCT05471934
Satisfaction Survey - Cicaplast Mains
An observational study of Hand Eczema and Hand Dermatoses, run by Cosmetique Active International at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Eczema, Hand Dermatoses
- How many people
- 380 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2014to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population corresponds to hairdressing professionals who are in permanent contact with irritating products (e.g. shampoos, hair colorants, oxidants, ...).
Who may be able to join
- 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
Who cannot join
- professionals that do not meet the inclusion criteria
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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.
- Conditions
- Hand Eczema, Hand Dermatoses
- Medical subject headings
- Hand Dermatoses
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction rate
satisfaction questionnaire with a 5-point scale
Measured: 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)
Measured: from baseline to Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Delphine Kerob, Study director, Cosmetique Active International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471934
- Sponsor's protocol ID
- LRP14011-CICAPLAST BAUME B5
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction Survey - Cicaplast Mains
- ClinicalTrials.gov ID
- NCT05471934
- Acronym / sponsor ID
- LRP14011-CICAPLAST BAUME B5
- Conditions
- Hand Eczema, Hand Dermatoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- Feb 2014 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population corresponds to hairdressing professionals who are in permanent contact with irritating products (e.g. shampoos, hair colorants, oxidants, ...).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- professionals that do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
satisfaction rate
Time frame: from baseline to Day28
satisfaction questionnaire with a 5-point scale
1 secondary outcome
evaluation of hands problems (dryness, redness, irritations, cracks, fissures)
Time frame: from baseline to Day28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delphine Kerob study director
Cosmetique Active International
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Eczema and Hand Dermatoses, run by Cosmetique Active International at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Poland, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satisfaction rate (time frame: from baseline to Day28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.