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

Skin Sensitisation Clinical Trial

— SAF DER ASSESS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03015103
• Other study ID #: Kley Hertz 006
• Status: Not yet recruiting
• Phase: N/A
• First received: December 29, 2016
• Last updated: January 5, 2017
• 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: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Skin Irritability
• Skin Sensitisation

Intervention

Device:
• 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.

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	Photoirritation as measured through the use of dressings containing tested product and placebo	The photoirritation will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and radiated with UVA. That procedure occurs during the period of five days.	5 days	Yes
Primary	Photosensitization as measured through the use of dressings containing tested product and placebo	The photosensitization will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and radiated with UVA. That procedure occurs during the period of 32 days.	32 days	Yes