Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT07085520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-25
First Post:
2025-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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:
CSEDSSDMP
Brief Summary:
The goal of this clinical trial is to evaluate the skin safety of a soluble denosumab microneedle patch in participants with osteoporosis and osteoarthritis. The main questions it aims to answer are:
* Is the soluble denosumab microneedle patch safe for use on the skin?
* What are the potential skin reactions to the patch?
Researchers will compare different doses of the microneedle patch to assess its safety.
Participants will:
* Apply the microneedle patch to four different areas around their knee
* Undergo skin assessments at various time points after application
* Be monitored for any adverse skin reactions
The study will take place at a single center and involve a small number of participants to provide preliminary data on the safety of this novel drug delivery system.
* Is the soluble denosumab microneedle patch safe for use on the skin?
* What are the potential skin reactions to the patch?
Researchers will compare different doses of the microneedle patch to assess its safety.
Participants will:
* Apply the microneedle patch to four different areas around their knee
* Undergo skin assessments at various time points after application
* Be monitored for any adverse skin reactions
The study will take place at a single center and involve a small number of participants to provide preliminary data on the safety of this novel drug delivery system.
Detailed Description:
None
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?: