NCT02419248

Completed

Dermatological Evaluation of Topical Compatibility, Primary ...

Kley Hertz S/A Source

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Other study identifiers

Sponsor study identifier

KLEY HERTZ-001

Study Type

observational

Actual enrollment (reported)

55

Locations

0 countries

Sites

N/A

Timeline

Study Start

June 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2015

Actual (reported)

Study Completion

July 2015

Actual (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: completed
Actual enrollment (reported): 55 participants
Study completion date: July 2015
Actual (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
April 14, 2015
Actual (reported)
First Posted
April 17, 2015
Actual (reported)
Study Start
June 2015
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)
Study Completion
July 2015
Actual (reported)

Last Updated: November 10, 2015
Status Verified: November 2015
Last Update Submitted: November 9, 2015

Conditions

Skin Irritability

Outcome Measures

Primary Outcomes (1)

Evaluation of adverse effects in maximized conditions
40 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

Enrollment

55 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 17, 2015

Study Start

June 2015

Date type not reported

This date has not been verified as actual or estimated.

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.

Primary Completion

June 2015

Actual (reported)

Study Completion

July 2015

Actual (reported)

Last Updated

November 10, 2015

Record last verified: 2015-11

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: NCT02419248
Data provider: ClinicalTrials.gov
Source updated: 2015-11-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:08 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record