Skin Sensitisation Clinical Trial
— SAF DER ASSESSOfficial title:
Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
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 |
The purpose of this study is to prove the product tested does not cause photoirritation or photosensitization reactions when exposed to sun light.
Status | Not yet recruiting |
Enrollment | 28 |
Est. completion date | |
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; |
Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Kley Hertz S/A |
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 |
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