A Phase 1/2 interventional study of Tacrolimus modified-release and tacrolimus ointment 0.1% in Oral Erosive Lichen Planus, sponsored by Hospital de Clinicas de Porto Alegre. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Hospital de Clinicas de Porto Alegre · Phase 1/2, Interventional, and Treatment
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:
Researchers will compare a spray of 0.08% tacrolimus nanoencapsulated aqueous solution against a 0.1% free tacrolimus commercial ointment to determine which formulation is more effective.
Participants will:
142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
This study's planned enrollment of 46 is above the median of 39 across 101 interventional studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
tacrolimus modified-release
Drug: Tacrolimus modified-release
Drug: tacrolimus ointment 0.1%
0.08% tacrolimus nanoencapsulated aqueous solution spray
0.1% free tacrolimus commercial ointment
Oral Disease Severity Score (ODSS) - 50%
Number of patients achieving a reduction of at least 50% in ODSS score compared to baseline and the percentage and absolute reduction in ODSS score in both groups at the end of treatment (30 days). ODSS score ranges from 0 to 106, lower score mean a better outcome.
Time frame: 30 days
VAS (visual analogical score) pain score - 50%
number of patients achieving a reduction of at least 50% in VAS score of reported pain compared to baseline and the percentage and absolute reduction in VAS score in both groups at the end of treatment (30 days). VAS score ranges from 0 to 10, lower score mean a better outcome.
Time frame: 30 days
OHIP-14 quality of life score
the percentage and absolute reduction in OHIP-14 scale score in both groups at mid-treatment and end of treatment (15 and 30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2). OHIP-14 score ranges from 0 to 56, lower score mean a better outcome.
Time frame: 15-90 days
Beck scale scores (anxiety levels)
The percentage and absolute reduction in Beck scale score in both groups at mid-treatment and end of treatment (15 and 30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2). OHIP-14 score ranges from 0 to 63, lower score mean a better outcome.
Time frame: 15-90 days
hedonic scale satisfaction scores
Comparison of hedonic scale scores of satisfaction reported by the participants in regards of treatment received in both groups at the end of treatment (30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2). Hedonic scale satisfaction score ranges from 0 to 9, higher score mean a better outcome.
Time frame: 30-90 days
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Dec 2027, 39 months after the start.
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