NCT04248556

Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization

Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization Under Controlled and Maximised Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Herbarium Laboratorio Botanico Ltda · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This is a clinical study for health care product safety assessment. The research will be conducted with 92 subjects, aged 18 to 59 years. The product will be applied on the right and/or left back of the research participants for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 48 hours. Medical evaluation will be available throughout the study to assess possible adverse events. The objective of the study is to observe the effects of the application of the product on the skin and prove the absence of irritability and/or allergy.

Detailed description

92 subjects, aged 18 to 59 years, phototypes I to IV (according to Fitzpatrick classification). The patch test will be used to verify the absence of primary and cumulative dermal irritation reactions and sensitization allergic reactions by the investigational products. The products will be applied as they are over semi-occlusive dressings.

Conditions

• Sensitivity, Contact

Interventions

Type	Name	Description
OTHER	Health care product	Health care product (gel) - to be applied on the participant's skin

Timeline

• Start date: 2021-03-09
• Primary completion: 2021-04-17
• Completion: 2021-04-17
• First posted: 2020-01-30
• Last updated: 2021-05-10

Locations

1 site across 1 country: Brazil