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Evaluate the potential of Primary Dermal Irritability, Accumulated Dermal Irritability, Dermal Sensitization, Photoallergy and Photosensitization, of health products through the application of Patch Test, proving the safety of the product for topical use. The study will be conducted with a Brazilian sample in which 55 research participants will be included. Depending on the results, the present study may support the claim: dermatologically tested, non-irritating, non-sensitizing, non-photoirritating and non-photosensitizing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Scar gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scar gel | Device | Scar gel (medical device - topical application) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence | Absence of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization under normal conditions and when exposed to sunlight. | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for the Phototest:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medcin Instituto da Pele Ltda | Osasco | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D010787 | Photosensitivity Disorders |
| D017484 | Dermatitis, Phototoxic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D017453 | Dermatitis, Irritant |
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