Skin IrritabilityDERM EV TOPICNCT02419248
Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation
An observational study of Skin Irritability, run by Kley Hertz S/A.
Trial summary
Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Irritability
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jul 2015
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with age from 18 to 70 years old, with skin color varying between clear caucasian to dark.
Who may be able to join
- Age between 18 to 70 years old;
- Skin types: I (light caucasian), II (caucasian), III (light dark) and IV (dark)
- intact skin where the product will be applied
- Agreement to comply with the test procedures and attend the clinic in the days and ixed times for medical assessments and application and reading of dressings
- Signature of informed consent form
Who cannot join
- Pregnancy and lactation
- Use of anti-inflammatory and immunosuppressive drugs from 30 days up to three months prior to selection;
- Diseases that cause immune suppression;
- Personal history of atopy;
- History of sensitisation and irritability to topical products;
- Active cutaneous pathologies (local and / or scattered) that may interfere in the study results;
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- Use of new drugs and/or cosmetics during the experiment;
- Skin reactivity;
- Previous participation in a study with the same product under test;
- Volunteers who have congenital or acquired known immunodeficiency;
- Relevant medical history or current evidence of alcohol or other drugs abuse;
- Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
- Sponsor's employees involved in the study, or close family member of an employee involved in the study;
About this study
Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.
- Conditions
- Skin Irritability
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of adverse effects in maximized conditions
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin IrritabilityStudies 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
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kley Hertz S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419248
- Sponsor's protocol ID
- KLEY HERTZ-001
- Acronym
- DERM EV TOPIC
- Status last verified
- Nov 2015
- First submitted
- 14 Apr 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation
- ClinicalTrials.gov ID
- NCT02419248
- Acronym / sponsor ID
- DERM EV TOPIC / KLEY HERTZ-001
- Conditions
- Skin Irritability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kley Hertz S/AIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Apr 2015 (estimated)
- 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.
Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with age from 18 to 70 years old, with skin color varying between clear caucasian to dark.
Key inclusion criteria (5 listed)
- Age between 18 to 70 years old;
- Skin types: I (light caucasian), II (caucasian), III (light dark) and IV (dark)
- intact skin where the product will be applied
- Agreement to comply with the test procedures and attend the clinic in the days and ixed times for medical assessments and application and reading of dressings
- Signature of informed consent form
Key exclusion criteria (13 listed)
- Pregnancy and lactation
- Use of anti-inflammatory and immunosuppressive drugs from 30 days up to three months prior to selection;
- Diseases that cause immune suppression;
- Personal history of atopy;
- History of sensitisation and irritability to topical products;
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
Evaluation of adverse effects in maximized conditions
Time frame: 40 days
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 10 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Irritability, run by Kley Hertz S/A.
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 5 inclusion and 13 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 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluation of adverse effects in maximized conditions (time frame: 40 days). 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 10 Nov 2015.