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

• Sponsor: B.P. Koirala Institute of Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02587117
• Collaborator: (none)
• Enrollment: 28
• Arms: 2
• Duration (Months): 12.9

Study Details

Study Description

Brief Summary

Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for the treatment of oral lichen planus. Half of participants (total number of participants was twenty eight) were received lycopene and the other half were received prednisolone.

Condition or Disease	Intervention/Treatment	Phase
Oral Lichen Planus	Drug: lycopene; Drug: Prednisolone	Phase 4

Detailed Description

Prednisolone and lycopene were produced remission of lesions in oral lichen planus patients, but they do so by different mechanisms.

The main cause of oral lichen planus is still unknown. Some authors advocate the disease appears to be a result of T-cell-mediated autoimmune responses in oral epithelial tissues. But, recent study suggests that increased reactive oxygen species (ROS) and lipid peroxidation together with an imbalance in the antioxidant defense system may play a part in the generation of disease.

Lycopene exerts its antioxidant activity by physical and chemical quenching of free radicals and decreases free radicals-initiated oxidative reactions, particularly lipid peroxidation and DNA oxidative damage, thereby preventing tissue damage.

Prednisone have both anti-inflammatory and immunosuppressant effects.It suppresses the inflammatory response by limiting the recruitment of inflammatory cells and inhibiting synthesis of pro-inflammatory products such as prostaglandins (PGs), leukotrienes (LTs) and platelet activating factors (PAF) by indirectly inhibiting phospholipase A2 and negative regulating cyclooxygenase (COX-2).

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Study of the Efficacy of Lycopene Versus Prednisolone in the Management of Oral Lichen Planus: A Randomized, Double Blind Clinical Trial
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lycopene group Lycopene- 4 mg capsule by mouth single dose per day for 2 months	Drug: 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.; Other Names: lycored
Active Comparator: Prednisolone group Prednisolone- 40 mg capsule by mouth single dose per day for 2 months	Drug: 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.; Other Names: wysolone

Outcome Measures

Primary Outcome Measures

1. Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score [8 weeks minus baseline]

   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.

Secondary Outcome Measures

1. Burning Sensation or Pain by Using NRS (Numerical Rating Scale) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject had symptomatic i.e. burning sensation and/or pain secondary to oral lichen planus.

• Subject had clinically & histo-pathologically diagnosed as oral lichen planus.

• Subject had not on any treatment for the same or treatment likely to modify their oral lichen planus (e.g. systemic steroids, antifungals, immunosuppressant's, anti-oxidant).

Exclusion Criteria:

• Suffering from any systemic disease/s such as diabetes, hypertension, cardiovascular, respiratory system disease, renal dysfunction, liver disorders, malignancy, active peptic ulcer diseases, acute gastrointestinal diseases, anemia and glaucoma, etc.

• Suffering from serious or recurrent infection, immunodeficiency or HIV.

• Pregnant or breast feeding (including women who wish to be pregnant during the study period).

• Any other mucosal diseases or any other skin diseases which might be associated with oral lesions.

• On any drug therapy which might be causes lichen planus like lesions.

• Known allergy or contraindication to study medications.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• B.P. Koirala Institute of Health Sciences

Investigators

• Principal Investigator: Ramayan Pr Kushwaha, MD, B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Ramayan Prasad Kushwaha, assistant professor, B.P. Koirala Institute of Health Sciences
• ClinicalTrials.gov Identifier: NCT02587117
• Other Study ID Numbers: 636/069/070
• First Posted: Oct 27, 2015
• Last Update Posted: Feb 26, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Dr. Ramayan Prasad Kushwaha, assistant professor, B.P. Koirala Institute of Health Sciences: Antioxidant; Lycopene; Prednisolone
• Additional relevant MeSH terms: Lichen Planus, Oral; Lichen Planus; Prednisolone; Lycopene

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Lycopene Group	Prednisolone Group
Arm/Group Description	Lycopene- 4 mg capsule by mouth single dose per day for 2 months	Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
Period Title: Overall Study
STARTED	13	15
COMPLETED	13	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lycopene Group	Prednisolone Group	Total
Arm/Group Description	Lycopene- 4 mg capsule by mouth single dose per day for 2 months	Prednisolone- 40 mg capsule by mouth single dose per day for 2 months	Total of all reporting groups
Overall Participants	13	15	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.69 (13.97)	48.07 (12.27)	45.11 (13.24)
Sex: Female, Male (Count of Participants)
Female	6 46.2%	12 80%	18 64.3%
Male	7 53.8%	3 20%	10 35.7%
Piboonniyom REU (Reticular, Erythematous and Ulceration) severity score (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	8.23 (5.85)	8.34 (7.83)	8.28 (6.86)
Baseline NRS (numerical rating scale) burning sensation score (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	3.69 (1.75)	3.60 (2.03)	3.64 (1.87)

Outcome Measures

1. Primary Outcome

Title	Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score
Description	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.
Time Frame	8 weeks minus baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lycopene Group	Prednisolone Group
Arm/Group Description	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- 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.
Measure Participants	13	15
Mean (Standard Deviation) [Scores on a scale]	2.15 (1.68)	0.73 (1.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lycopene Group, Prednisolone Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mann Whitney test
	Comments

2. Secondary Outcome

Title	Burning Sensation or Pain by Using NRS (Numerical Rating Scale)
Description	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.
Time Frame	8 weeks minus baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lycopene Group	Prednisolone Group
Arm/Group Description	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- 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.
Measure Participants	13	15
Mean (Standard Deviation) [Scores on a scale]	0.23 (0.44)	0.07 (0.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lycopene Group, Prednisolone Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.224
	Comments
	Method	Mann Whitney test
	Comments

Adverse Events

Time Frame	Daily monitoring throughout 8 weeks of treatment
Arm/Group Title	Lycopene Group		Prednisolone Group
Arm/Group Description	Lycopene- 4 mg capsule by mouth single dose per day for 2 months		Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
All Cause Mortality
	Lycopene Group		Prednisolone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lycopene Group		Prednisolone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Lycopene Group		Prednisolone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/13 (76.9%)		15/15 (100%)
Eye disorders
Blurred vision	0/13 (0%)	0	4/15 (26.7%)	4
Gastrointestinal disorders
Epigastric pain	0/13 (0%)	0	6/15 (40%)	6
Flatulency	9/13 (69.2%)	9	0/15 (0%)	0
Nausea	4/13 (30.8%)	4	1/15 (6.7%)	1
Increased appetite	3/13 (23.1%)	3	0/15 (0%)	0
Abdominal distension	2/13 (15.4%)	2	0/15 (0%)	0
Diarrhea	2/13 (15.4%)	2	0/15 (0%)	0
General disorders
Puffiness of face	0/13 (0%)	0	13/15 (86.7%)	13
Fatigue	0/13 (0%)	0	1/15 (6.7%)	1
Nervous system disorders
Headache	1/13 (7.7%)	1	10/15 (66.7%)	10
Dizziness	1/13 (7.7%)	1	8/15 (53.3%)	8
Insomnia	0/13 (0%)	0	3/15 (20%)	3

Limitations/Caveats

Due to limitation of time, there were small numbers of subjects enrollment; not possible to follow-up the cases after the treatments were over and to determine the relapse rate of the patients; performed at a single medical center.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.