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| ID | Type | Description | Link |
|---|---|---|---|
| 76823524.3.1001.5327 | Other Identifier | Hospital de Clinicas de Porto Alegre |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.08% tacrolimus nanoencapsulated aqueous solution spray | Experimental | tacrolimus modified-release |
|
| 0.1% free tacrolimus commercial ointment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus modified-release | Drug | 0.08% tacrolimus nanoencapsulated aqueous solution spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15-90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernanda Visioli, DDS, PhD | Contact | +55 51 3308-5011 | fvisioli@hcpa.edu.br | |
| Erick S Pedraça, DDS, MsC | Contact | erickspedraca@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fernanda Visioli, DDS, PhD | Hospital de Clínicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
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| tacrolimus ointment 0.1% | Drug | 0.1% free tacrolimus commercial ointment |
|
| 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. |
| 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. | 30-90 days |
| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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