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.
142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
This study's enrollment of 29 is below the median of 39 across 101 interventional studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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 biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug page: Dexamethasone
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
Drug page: 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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Final results will be submitted for publication on a peer reviewed journal
Ran from Dec 2020 to primary completion in Jan 2023, 24 months.
Results were first posted in Dec 2023, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dexamethasone
University of California, San Francisco →