Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591884
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Evaluation of the Efficacy of 008 Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs 01 Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Efficacy of 008 Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs 01 Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus - a Randomized Clinical Trial
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 this clinical trial is to assess the efficacy of different formulations of the drug tacrolimus in treating patients with oral lichen planus The main questions it aims to answer are
Does the nanoencapsulation of tacrolimus in an aqueous solution used as a spray improve the effectiveness of treating oral lichen planus lesions compared to the commercially available tacrolimus ointment
Which tacrolimus formulation can keep participants free of lesions for longer periods
Researchers will compare a spray of 008 tacrolimus nanoencapsulated aqueous solution against a 01 free tacrolimus commercial ointment to determine which formulation is more effective
Participants will
Apply one of the proposed tacrolimus formulations twice a day for 1 month
Visit the clinic once every 2 weeks for checkups and tests with follow-ups extending up to 3 months
Does the nanoencapsulation of tacrolimus in an aqueous solution used as a spray improve the effectiveness of treating oral lichen planus lesions compared to the commercially available tacrolimus ointment
Which tacrolimus formulation can keep participants free of lesions for longer periods
Researchers will compare a spray of 008 tacrolimus nanoencapsulated aqueous solution against a 01 free tacrolimus commercial ointment to determine which formulation is more effective
Participants will
Apply one of the proposed tacrolimus formulations twice a day for 1 month
Visit the clinic once every 2 weeks for checkups and tests with follow-ups extending up to 3 months
Detailed Description:
None
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