Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity (SAF DER ASSESS)

Kley Hertz

Status: Completed

Conditions: Skin Sensitization; Skin Irritability

Treatments: Device: KL029 Intimate Lubricant Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02441608

KLEY HERTZ-002

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 18 to 60 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;

Trial design

28 participants in 1 patient group

Experimental group

Experimental group

Description:

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.

Treatment:

Device: KL029 Intimate Lubricant Gel