Skin IrritabilityDERM EV TOPICNCT03007498

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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: Jan 2017to Feb 2017
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;

Show all 13Show fewer

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: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2017Feb 2017

First posted2 Jan 2017 (estimated)
Study startJan 2017
Primary completionFeb 2017 (estimated)

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 (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03007498
Sponsor's protocol ID: Kley Hertz 005
Acronym: DERM EV TOPIC
Status last verified: Dec 2016
First submitted: 29 Dec 2016
Last updated: 2 Jan 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
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Active, not recruiting
Shaving Satisfaction in Males With Skin Irritation From Shaving
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Recruiting
IBS Skin Patch Test Food Allergy Study
Irritable Bowel Syndrome
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications

All Skin Irritability trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2017. 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: NCT03007498
Acronym / sponsor ID: DERM EV TOPIC / Kley Hertz 005
Conditions: Skin Irritability
Study type: Observational
Recruitment status: Unknown status
Enrolment: 55 participants (estimated)
Lead sponsor: Kley Hertz S/AIndustry (pharma, biotech, devices)
Study start: Jan 2017
Primary completion: Feb 2017 (estimated)
First posted: 2 Jan 2017 (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: 60 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.

Related trials for Skin Irritability

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Active, not recruiting
Shaving Satisfaction in Males With Skin Irritation From Shaving
Pseudofolliculitis Barbae
Recruiting
IBS Skin Patch Test Food Allergy Study
Irritable Bowel Syndrome
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications

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: status not confirmed, as of the sponsor's last update on 2 Jan 2017. 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?

Results are not available in the source record.

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: 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03007498.

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 2 Jan 2017.