Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT04248556
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2020-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization
Sponsor:
Herbarium Laboratorio Botanico Ltda
Organization:
Study Overview
Official Title:
Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization Under Controlled and Maximised Conditions
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: