A Phase 2 interventional study of dexamethasone 0.5mg/5ml solution and dexamethasone 0.5mg/5ml solution in Mucolox™ in Oral Lichen Planus, Mucous Membrane Pemphigoid and Pemphigus Vulgaris, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Dexamethasone solution (0.5mg/5ml) in Mucolox™ three times a day (TID) swish and spit for 4 weeks
Drug: dexamethasone 0.5mg/5ml solution in Mucolox™
Dexamethasone solution (0.5mg/5ml) TID swish and spit for 4 weeks
Drug: 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
Also known as: dexamethasone
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
Also known as: dexamethasone solution in Mucolox™
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
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
| Milestone | Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Dexamethasone 0.5mg/5ml Solution (Arm B) |
|---|---|---|
| Started | 15 | 14 |
| Completed | 14 | 14 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
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.
| score on a scale | Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Dexamethasone 0.5mg/5ml Solution (Arm B) |
|---|---|---|
| Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks | 6.3 ± 2.4 | 4.4 ± 3.3 |
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
| score on a scale | Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Dexamethasone 0.5mg/5ml Solution (Arm B) |
|---|---|---|
| Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks | 2.5 ± 3.1 | 3.2 ± 1.7 |
Collected over 1 month (study period). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Dexamethasone 0.5mg/5ml Solution (Arm B) | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Dexamethasone 0.5mg/5ml Solution (Arm B) | Total |
|---|---|---|---|
| Median | 58 (30 to 79) | 67 (18 to 78) | 58 (18 to 79) |
| Sex: Female, Male(Participants) | Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Dexamethasone 0.5mg/5ml Solution (Arm B) | Total |
|---|---|---|---|
| Female | 10 | 12 | 22 |
| Male | 5 | 2 | 7 |
| Race and Ethnicity Not Collected(Participants) | Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Dexamethasone 0.5mg/5ml Solution (Arm B) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | Dexamethasone 0.5mg/5ml Solution (Arm B) | Total |
|---|---|---|---|
| United States | 15 | 14 | 29 |
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Plan to share: No — Final results will be submitted for publication on a peer reviewed journal
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University of California, San Francisco