NCT03007498

Unknown

Dermatological Evaluation of Topical Compatibility, Primary ...

Kley Hertz S/A Source

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Other study identifiers

Sponsor study identifier

Kley Hertz 005

Study Type

observational

Estimated enrollment

55

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 2017

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2017

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

Not reported

Date not reported

Brief Summary

Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 55 participants
Study completion date: Not reported
Date not reported
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 29, 2016
Actual (reported)
Study Start
January 2017
Date type not reported
This date has not been verified as actual or estimated.
First Posted
January 2, 2017
Actual (reported)
Primary Completion
February 2017
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: January 2, 2017
Status Verified: December 2016
Last Update Submitted: December 29, 2016

Conditions

Skin Irritability

Outcome Measures

Primary Outcomes (1)

Evaluation of adverse effects in maximized conditions
60 days

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with age from 18 to 70 years old, with skin color varying between clear caucasian to dark.

You may qualify if:

Age between 18 to 70 years old;

Sponsors & Collaborators

Kley Hertz S/A
Industrylead

Study Design

Study Type: observational
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 2, 2017

Study Start

January 2017

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2017

Estimated (date passed)

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

You may not qualify if:

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;
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;

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

January 2, 2017

Record last verified: 2016-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03007498
Data provider: ClinicalTrials.gov
Source updated: 2017-01-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:58 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Design

Study Record Dates

You may not qualify if:

Source record