Trial Outcomes & Findings for A Clinical Trial to Study the Effects of Two Drugs, Lycopene and Prednisolone in Patients With Oral Lichen Planus (NCT NCT02587117)

Last Updated: 2016-02-26

Results Overview

Reticular: score 0= no white striations; score 1= white striations. Erythematous: score 0= no lesion; score 1= lesion \<1 cm2; score 2: lesion 1-3 cm2; score 3= lesion \>3 cm2. Ulceration: score 0= no lesion; score 1= lesion \<1 cm2; score 2= lesion 1-3 cm2; score 3= lesion \>3 cm2. Total weighted score was derived by sum total scores of each lesion and multiplication with weighted score 1.5 \& 2.0 in total erythematous and total ulceration scores as ΣR + ΣE × 1.5 + ΣU × 2.0.Total weighted score was dependent on the number of lesions of each participant which was not the same across participants. Higher value of the total score represent worse outcome \& zero value represent no lesion.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

28 participants

Primary outcome timeframe

8 weeks minus baseline

Results posted on

2016-02-26

Participant Flow

Only symptomatic oral lichen planus patients, who were fulfill inclusion and exclusion criteria, were selected and recruited from the outpatient department of Oral Medicine and Radiology, College of dental surgery, BPKIHS on the basis of randomization list. The first patients was recruited on 21/02/2013 and the last patients was on 28/01/2014.

Before enrollment, full explanation about the study was given and written informed consent was taken. A detailed clinical history, clinical examination,baseline investigations and punch biopsy were taken. Patient was on treatment with medication for the same lesions asked to stop the treatment and a washout period of 3 weeks was given.

Participant milestones

Participant milestones
Measure	Lycopene Group Lycopene- 4 mg capsule by mouth single dose per day for 2 months	Prednisolone Group Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
Overall Study STARTED	13	15
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Trial to Study the Effects of Two Drugs, Lycopene and Prednisolone in Patients With Oral Lichen Planus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lycopene Group n=13 Participants Lycopene- 4 mg capsule by mouth single dose per day for 2 months	Prednisolone Group n=15 Participants Prednisolone- 40 mg capsule by mouth single dose per day for 2 months	Total n=28 Participants Total of all reporting groups
Age, Continuous	41.69 years STANDARD_DEVIATION 13.97 • n=5 Participants	48.07 years STANDARD_DEVIATION 12.27 • n=7 Participants	45.11 years STANDARD_DEVIATION 13.24 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Piboonniyom REU (Reticular, Erythematous and Ulceration) severity score	8.23 Scores on a scale STANDARD_DEVIATION 5.85 • n=5 Participants	8.34 Scores on a scale STANDARD_DEVIATION 7.83 • n=7 Participants	8.28 Scores on a scale STANDARD_DEVIATION 6.86 • n=5 Participants
Baseline NRS (numerical rating scale) burning sensation score	3.69 Scores on a scale STANDARD_DEVIATION 1.75 • n=5 Participants	3.60 Scores on a scale STANDARD_DEVIATION 2.03 • n=7 Participants	3.64 Scores on a scale STANDARD_DEVIATION 1.87 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks minus baseline

Outcome measures

Outcome measures
Measure	Lycopene Group n=13 Participants Lycopene- 4 mg capsule by mouth single dose per day for 2 months lycopene: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.	Prednisolone Group n=15 Participants Prednisolone- 40 mg capsule by mouth single dose per day for 2 months Prednisolone: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.
Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score	2.15 Scores on a scale Standard Deviation 1.68	0.73 Scores on a scale Standard Deviation 1.58

SECONDARY outcome

Timeframe: 8 weeks minus baseline

Standard self-response Numerical Rating Scale (NRS) of 0 (no oral discomfort) to 10 (worst imaginable oral discomfort) to represent the intensity of burning sensation or pain or discomfort. The mean of NRS burning sensation score was calculated after eight weeks of treatment and considered as 8th week NRS burning sensation score.

Outcome measures

Outcome measures
Measure	Lycopene Group n=13 Participants Lycopene- 4 mg capsule by mouth single dose per day for 2 months lycopene: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.	Prednisolone Group n=15 Participants Prednisolone- 40 mg capsule by mouth single dose per day for 2 months Prednisolone: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.
Burning Sensation or Pain by Using NRS (Numerical Rating Scale)	0.23 Scores on a scale Standard Deviation 0.44	0.07 Scores on a scale Standard Deviation 0.26

Adverse Events

Lycopene Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Prednisolone Group

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lycopene Group n=13 participants at risk Lycopene- 4 mg capsule by mouth single dose per day for 2 months	Prednisolone Group n=15 participants at risk Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
General disorders Puffiness of face	0.00% 0/13 • Daily monitoring throughout 8 weeks of treatment	86.7% 13/15 • Number of events 13 • Daily monitoring throughout 8 weeks of treatment
Nervous system disorders Headache	7.7% 1/13 • Number of events 1 • Daily monitoring throughout 8 weeks of treatment	66.7% 10/15 • Number of events 10 • Daily monitoring throughout 8 weeks of treatment
Nervous system disorders Dizziness	7.7% 1/13 • Number of events 1 • Daily monitoring throughout 8 weeks of treatment	53.3% 8/15 • Number of events 8 • Daily monitoring throughout 8 weeks of treatment
Gastrointestinal disorders Epigastric pain	0.00% 0/13 • Daily monitoring throughout 8 weeks of treatment	40.0% 6/15 • Number of events 6 • Daily monitoring throughout 8 weeks of treatment
Eye disorders Blurred vision	0.00% 0/13 • Daily monitoring throughout 8 weeks of treatment	26.7% 4/15 • Number of events 4 • Daily monitoring throughout 8 weeks of treatment
Gastrointestinal disorders Flatulency	69.2% 9/13 • Number of events 9 • Daily monitoring throughout 8 weeks of treatment	0.00% 0/15 • Daily monitoring throughout 8 weeks of treatment
Gastrointestinal disorders Nausea	30.8% 4/13 • Number of events 4 • Daily monitoring throughout 8 weeks of treatment	6.7% 1/15 • Number of events 1 • Daily monitoring throughout 8 weeks of treatment
Gastrointestinal disorders Increased appetite	23.1% 3/13 • Number of events 3 • Daily monitoring throughout 8 weeks of treatment	0.00% 0/15 • Daily monitoring throughout 8 weeks of treatment
Gastrointestinal disorders Abdominal distension	15.4% 2/13 • Number of events 2 • Daily monitoring throughout 8 weeks of treatment	0.00% 0/15 • Daily monitoring throughout 8 weeks of treatment
Gastrointestinal disorders Diarrhea	15.4% 2/13 • Number of events 2 • Daily monitoring throughout 8 weeks of treatment	0.00% 0/15 • Daily monitoring throughout 8 weeks of treatment
Nervous system disorders Insomnia	0.00% 0/13 • Daily monitoring throughout 8 weeks of treatment	20.0% 3/15 • Number of events 3 • Daily monitoring throughout 8 weeks of treatment
General disorders Fatigue	0.00% 0/13 • Daily monitoring throughout 8 weeks of treatment	6.7% 1/15 • Number of events 1 • Daily monitoring throughout 8 weeks of treatment

Additional Information

Dr. Ramayan Prasad Kushwaha

B.P. Koirala Institute of Health Sciences

Phone: 977-9842207716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place