Skin Irritability, Skin Sensitisation
Conditions
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.
Interventions
DEVICEIntimate 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.
Sponsors
Kley Hertz S/A
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photoirritation as measured through the use of dressings containing tested product and placebo | 5 days | 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. |
| Photosensitization as measured through the use of dressings containing tested product and placebo | 32 days | 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. |
Outcome results
None listed