Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608238
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
The Purpose of This Study is to Evaluate the Safety and Efficacy of D-MNA in Adult Patients With Nodular Basal Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blinded Placebo Controlled Trial to Evaluate the Safety and Efficacy of a Doxorubicin Microneedle Array D-MNA for the Treatment of Nodular Basal Cell Carcinoma in Adults
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the study is to learn about the safety and how effective two different strengths of D-MNA compared to a placebo a look-alike substance that contains no drug in the treatment of nodular basal cell skin cancer
Detailed Description:
A double-blind randomized placebo-controlled study designed to evaluate the safety and efficacy of D-MNA which is administered as an intradermal injection in subjects with nodular Basal Cell Carcinoma nBCC
About 60 subjects will be enrolled Enrolled subjects will be randomly allocated to receive D-MNA or placebo injection on the identified target lesion once weekly for 3 weeks
After two weeks the target lesion will be excised
An Interim Analysis will be done after 26-30 subjects would have completed Visit 5 Excision Visit
About 60 subjects will be enrolled Enrolled subjects will be randomly allocated to receive D-MNA or placebo injection on the identified target lesion once weekly for 3 weeks
After two weeks the target lesion will be excised
An Interim Analysis will be done after 26-30 subjects would have completed Visit 5 Excision Visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None