Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity

NCT ID: NCT03015103

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31

Brief Summary

The purpose of this study is to prove the product tested does not cause photoirritation or photosensitization reactions when exposed to sun light.

Conditions

Skin Irritability; Skin Sensitisation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

Experimental group

This study is designed as a single group assignment, because the 4 dressings (3 placebos and 1 containing the product) will be applied in all volunteers. This means that the region in which the tested product will be applied will be compared with the other placebo regions in the same volunteer.

Group Type: EXPERIMENTAL

Intimate Lubrificant Gel

Intervention Type: DEVICE

All the volunteers will receive the application of four dressings (3 placebos and 1 containing the tested product). After a certain period of time, photoirritation and photosensitization will be measured through the evaluation of tested region.

Interventions

Intimate Lubrificant Gel

All the volunteers will receive the application of four dressings (3 placebos and 1 containing the tested product). After a certain period of time, photoirritation and photosensitization will be measured through the evaluation of tested region.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age between 18 to 70 years old;
• Skin types: I (light caucasian) or III (light brown);
• Intact skin where the product will be applied;
• Agreement to comply with the test procedures and attend the clinic in the days and fixed 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 from 30 days up to three months prior to selection;
• Diseases that cause immune suppression;
• Use of photosensitizing drugs;
• History or photodermatoses activities;
• Personal or family history of photoinduced skin cancer;
• Presence of precursor lesions of skin cancer, such as melanocytic nevi and actinic keratoses;
• Intense sun exposure in the experiment area Use of new drugs and/or cosmetics during the experiment;
• Previous participation in a study with the same product under test;
• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kley Hertz S/A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Kley Hertz 006

Identifier Type: -

Identifier Source: org_study_id