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

NCT02441608 | Completed

• 1 other identifier: KLEY HERTZ-002
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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 Sensitization

Outcome Measures

Primary Outcomes (2)

• 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 irradiated with UVA. That procedure occurs during the period of five days.

  05 days

• 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 irradiated with UVA. That procedure occurs during the period of 32 days.

  32 days

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Device: KL029 Intimate Lubricant Gel

Interventions

KL029 Intimate Lubricant Gel 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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Kley Hertz S/A: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: May 12, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11