Chronic Graft-versus-host-disease, Mucous Membrane Pemphigoid, Oral Lichen Planus, Pemphigus Vulgaris
Conditions
Brief summary
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.
Interventions
DRUGdexamethasone 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
DRUGdexamethasone 0.5mg/5ml solution in Mucolox™
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
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years and older. * Patients with symptomatic biopsy proven Oral Inflammatory Ulcerative Diseases (worst VAS sensitivity score ≥ 7 over the last week). * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Patients already on topical or systemic steroids. * Inability to comply with study instructions. * Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements. * VAS sensitivity score \< 7. * Pregnant women. A urine pregnancy test will be performed for women of child bearing potential. * Allergy to fluconazole.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 14 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Dexamethasone 0.5mg/5ml Solution (Arm B) | Total | Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) |
|---|---|---|---|
| Age, Continuous | 67 years | 58 years | 58 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 14 Participants | 29 Participants | 15 Participants |
| Sex: Female, Male Female | 12 Participants | 22 Participants | 10 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks | 6.3 score on a scale | Standard Deviation 2.4 |
| Dexamethasone 0.5mg/5ml Solution (Arm B) | Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks | 4.4 score on a scale | Standard Deviation 3.3 |
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
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks | 2.5 score on a scale | Standard Deviation 3.1 |
| Dexamethasone 0.5mg/5ml Solution (Arm B) | Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks | 3.2 score on a scale | Standard Deviation 1.7 |