Trial Outcomes & Findings for Dexamethasone Solution and Dexamethasone in Mucolox™ (NCT NCT04540133)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

4 weeks

Results posted on

2023-12-15

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	15	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) n=15 Participants 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	Dexamethasone 0.5mg/5ml Solution (Arm B) n=14 Participants 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	Total n=29 Participants Total of all reporting groups
Age, Continuous	58 years n=15 Participants	67 years n=14 Participants	58 years n=29 Participants
Sex: Female, Male Female	10 Participants n=15 Participants	12 Participants n=14 Participants	22 Participants n=29 Participants
Sex: Female, Male Male	5 Participants n=15 Participants	2 Participants n=14 Participants	7 Participants n=29 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	15 Participants n=15 Participants	14 Participants n=14 Participants	29 Participants n=29 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) n=14 Participants 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 will be asked to rinse with dexamethasone 0.5mg/5ml solution in Mucolox™ three times a day for 4 weeks and expectorate	Dexamethasone 0.5mg/5ml Solution (Arm B) n=14 Participants 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
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	4.4 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) n=14 Participants 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 will be asked to rinse with dexamethasone 0.5mg/5ml solution in Mucolox™ three times a day for 4 weeks and expectorate	Dexamethasone 0.5mg/5ml Solution (Arm B) n=14 Participants 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
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	3.2 score on a scale Standard Deviation 1.7

Adverse Events

Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone 0.5mg/5ml Solution (Arm B)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alessandro Villa

UCSF

Phone: 415-476-2045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place