Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Topical steroid therapy is considered the first line of treatment for Oral Inflammatory Ulcerative Diseases with current treatment regimens requiring multiple application or rinses daily. Using Mucolox™ as a vehicle to deliver topical dexamethasone to the oral mucosa has the potential to effectively prolong contact time between the medication. The primary objective of this study is to determine the clinical efficacy and tolerability of compound dexamethasone at 0.5 mg/5 mL in Mucolox™ for the treatment of Oral Inflammatory Ulcerative Diseases as measured by a reduction in oral symptoms between patients treated with compounded dexamethasone 0.5mg/5ml solution in Mucolox™ (group A) and patients treated with topical commercial dexamethasone 0.5mg/5ml solution only (group B). and mucosa, leading to improved clinical outcomes due to the need for less frequent application.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexamethasone 0.5mg/5ml solution in Mucolox™ (group A) | Experimental | Dexamethasone solution (0.5mg/5ml) in Mucolox™ three times a day (TID) swish and spit for 4 weeks |
|
| dexamethasone 0.5mg/5ml solution (Arm B) | Active Comparator | Dexamethasone solution (0.5mg/5ml) TID swish and spit for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone 0.5mg/5ml solution | Drug | Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution three times a day for 4 weeks and expectorate |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks | Oral Pain Scores were measured on the Visual Analog Scale (VAS), the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. The pain score measured on a VAS scale will be compared between group A and group B to detect any significant differences pre and post treatment at 4 weeks. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks | Oral lesions were scored using the REU (reticulation,erythema and ulcer) system (form 0 till 49.5). Reticulations were scored from 0 to 1 (0 = no white striations, 1 = presence of white striations or keratotic papules); erythematous lesions from 0 to 3 by area of involvement (0 = no lesion, 1 = lesions less than 1 cm2, 2 = lesions from 1 to 3 cm2, 3 = lesions greater than 3 cm2); ulcers from 0 to 3 by area of involvement. The higher is the score the more severe is the disease. In order to evaluate the clinical improvement in clinician-reported outcome measures for oral lesions, REU scores within the compound dexamethasone solution in Mucolox™ group (Arm A) will be compared to that in the dexamethasone solution only group (Arm B). The REU scores will be summarized descriptively for each arm at pre-treatment, post-treatment, and pre-to-post treatment change. The pre-to-post treatment change will be compared between the arms using either student's t-test o |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Villa, DDS, PhD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sol Silverman Oral Medicine Clinic - UCSF | San Francisco | California | 94117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37549933 | Derived | Lodolo M, Thanasuwat B, Veluppillai P, Bassani G, Villa A. Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral inflammatory ulcerative diseases: A phase II randomized clinical trial. J Oral Pathol Med. 2023 Oct;52(9):860-866. doi: 10.1111/jop.13471. Epub 2023 Aug 7. |
Not provided
Not provided
Final results will be submitted for publication on a peer reviewed journal
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Dexamethasone solution (0.5mg/5ml) in Mucolox™ three times a day (TID) swish and spit for 4 weeks dexamethasone 0.5mg/5ml solution in Mucolox™: Patient with oral ulcerative conditions were asked to rinse with dexamethasone 0.5mg/5ml solution in Mucolox™ three times a day for 4 weeks and expectorate |
| FG001 | Dexamethasone 0.5mg/5ml Solution (Arm B) | Dexamethasone solution (0.5mg/5ml) TID swish and spit for 4 weeks dexamethasone 0.5mg/5ml solution: Patient with oral ulcerative conditions were asked to rinse with dexamethasone 0.5mg/5ml solution three times a day for 4 weeks and expectorate |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Dexamethasone solution (0.5mg/5ml) in Mucolox™ three times a day (TID) swish and spit for 4 weeks dexamethasone 0.5mg/5ml solution in Mucolox™: Patient with oral ulcerative conditions were asked to rinse with dexamethasone 0.5mg/5ml solution in Mucolox™ three times a day for 4 weeks and expectorate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks | Oral Pain Scores were measured on the Visual Analog Scale (VAS), the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. The pain score measured on a VAS scale will be compared between group A and group B to detect any significant differences pre and post treatment at 4 weeks. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
1 month (study period)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Dexamethasone solution (0.5mg/5ml) in Mucolox™ three times a day (TID) swish and spit for 4 weeks dexamethasone 0.5mg/5ml solution in Mucolox™: Patient with oral ulcerative conditions were asked to rinse with dexamethasone 0.5mg/5ml solution in Mucolox™ three times a day for 4 weeks and expectorate |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alessandro Villa | UCSF | 415-476-2045 | Alessandro.Villa@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2020 | Nov 28, 2023 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| D010390 | Pemphigoid, Benign Mucous Membrane |
| D010392 | Pemphigus |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| dexamethasone 0.5mg/5ml solution in Mucolox™ | Drug | Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution in Mucolox™ three times a day for 4 weeks and expectorate |
|
|
| 4 weeks |
| BG001 |
| Dexamethasone 0.5mg/5ml Solution (Arm B) |
Dexamethasone solution (0.5mg/5ml) TID swish and spit for 4 weeks dexamethasone 0.5mg/5ml solution: Patient with oral ulcerative conditions were asked to rinse with dexamethasone 0.5mg/5ml solution three times a day for 4 weeks and expectorate |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Dexamethasone 0.5mg/5ml Solution (Arm B) |
Dexamethasone solution (0.5mg/5ml) TID swish and spit for 4 weeks dexamethasone 0.5mg/5ml solution: Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution three times a day for 4 weeks and expectorate |
|
|
| Secondary | Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks | Oral lesions were scored using the REU (reticulation,erythema and ulcer) system (form 0 till 49.5). Reticulations were scored from 0 to 1 (0 = no white striations, 1 = presence of white striations or keratotic papules); erythematous lesions from 0 to 3 by area of involvement (0 = no lesion, 1 = lesions less than 1 cm2, 2 = lesions from 1 to 3 cm2, 3 = lesions greater than 3 cm2); ulcers from 0 to 3 by area of involvement. The higher is the score the more severe is the disease. In order to evaluate the clinical improvement in clinician-reported outcome measures for oral lesions, REU scores within the compound dexamethasone solution in Mucolox™ group (Arm A) will be compared to that in the dexamethasone solution only group (Arm B). The REU scores will be summarized descriptively for each arm at pre-treatment, post-treatment, and pre-to-post treatment change. The pre-to-post treatment change will be compared between the arms using either student's t-test o | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Dexamethasone 0.5mg/5ml Solution (Arm B) | Dexamethasone solution (0.5mg/5ml) TID swish and spit for 4 weeks dexamethasone 0.5mg/5ml solution: Patient with oral ulcerative conditions were asked to rinse with dexamethasone 0.5mg/5ml solution three times a day for 4 weeks and expectorate | 0 | 14 | 0 | 14 | 0 | 14 |
Not provided
Not provided
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D012872 | Skin Diseases, Vesiculobullous |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004364 | Pharmaceutical Preparations |