Trial Outcomes & Findings for Dexamethasone Solution for the Treatment of Oral Lichen Planus (NCT NCT02850601)

NCT ID: NCT02850601

Last Updated: 2021-06-14

Results Overview

Subjects scored their worse sensitivity while eating over the past week. This score is substracted from their initial reported sensitivity at baseline. Reduction in oral symptoms of the worst sensitivity experienced in the past week on an 11 point scale (visual analogue scale 0-10). O signifies no sensitivity; 10 maximum sensitivity substracted from the same score collected at baseline before the treatment was initiated.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: 4 weeks after the start of the trial
• Results posted on: 2021-06-14

Participant Flow

Participant milestones

Measure	Dexamethasone Solution Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate	Dexamethasone Solution in Mucolox™ Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dexamethasone Solution for the Treatment of Oral Lichen Planus

Baseline characteristics by cohort

Measure	Dexamethasone Solution n=12 Participants Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate	Dexamethasone Solution in Mucolox™ n=12 Participants Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate	Total n=24 Participants Total of all reporting groups
Age, Continuous	80.2 years n=5 Participants	58.8 years n=7 Participants	69.5 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sensitivity at baseline on a 0-10 scale	8 units on a scale n=5 Participants	8 units on a scale n=7 Participants	8 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks after the start of the trial

Subjects scored their worse sensitivity while eating over the past week. This score is substracted from their initial reported sensitivity at baseline.

Reduction in oral symptoms of the worst sensitivity experienced in the past week on an 11 point scale (visual analogue scale 0-10). O signifies no sensitivity; 10 maximum sensitivity substracted from the same score collected at baseline before the treatment was initiated.

Outcome measures

Measure	Dexamethasone Rinses n=12 Participants 12 subjects A four-week supply of dexamethasone solution (0.1mg/ml) was dispensed and subjects were instructed to swish for 5 minutes and expectorate with 5 mL of solution, three times a day, and to avoid eating or drinking for 15 minutes	Dexamethasone in Mucolox Rinses n=12 Participants 12 subjects A four-week supply of dexamethasone in Mucolox at 0.1mg/ml was dispensed and subjects were instructed to swish for 5 minutes and expectorate with 5 mL of solution, three times a day, and to avoid eating or drinking for 15 minutes
Change in Oral Sensitivity	-4.5 score on a scale Standard Error 2.5	-6.0 score on a scale Standard Error 1.5

Adverse Events

Dexamethasone Solution

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone Solution in Mucolox™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexamethasone Solution n=12 participants at risk Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate	Dexamethasone Solution in Mucolox™ n=12 participants at risk Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
Gastrointestinal disorders constipation; abdomional discomfort	8.3% 1/12 • Number of events 1 • Onset of symptoms were reported 4-5 days after initiating the treatment and lasted 24h. The treatment was interrupted for 2 days and resumed thereafter with no recurrence or any other adverse event. The subject was monitored through study completion (4 weeks after baseline). Abdominal discomfort 4-5 days after initiating study drug. Study drug was discontinued and event ended 2 days later and did not recur.	0.00% 0/12 • Onset of symptoms were reported 4-5 days after initiating the treatment and lasted 24h. The treatment was interrupted for 2 days and resumed thereafter with no recurrence or any other adverse event. The subject was monitored through study completion (4 weeks after baseline). Abdominal discomfort 4-5 days after initiating study drug. Study drug was discontinued and event ended 2 days later and did not recur.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Herve Sroussi

BWH

Phone: 617 5256864

Email: hsroussi@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place