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

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

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

Conditions
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Skin Irritability, Skin Sensitization

Intervention / Treatment
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* Device: KL029 Intimate Lubricant Gel


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |