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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03007498
Other study ID # Kley Hertz 005
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 29, 2016
Last updated December 29, 2016
Start date January 2017

Study information

Verified date December 2016
Source Kley Hertz S/A
Contact n/a
Is FDA regulated No
Health authority Brazil: Brasilian Health Surveillance Agency
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 55
Est. completion date
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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;

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kley Hertz S/A

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of adverse effects in maximized conditions 60 days Yes
See also
  Status Clinical Trial Phase
Completed NCT02419248 - Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation N/A
Completed NCT02441608 - Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity N/A
Not yet recruiting NCT03015103 - Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity N/A