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

NCT02587117 | Completed Phase 4 Results DMC

• 1 other identifier: 636/069/070
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Lichen Planus

Keywords

Antioxidant; Lycopene; Prednisolone

Outcome Measures

Primary Outcomes (1)

• Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score

  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.

  8 weeks minus baseline

Secondary Outcomes (1)

• Burning Sensation or Pain by Using NRS (Numerical Rating Scale)

  8 weeks minus baseline

Study Arms (2)

lycopene group

EXPERIMENTAL

Lycopene- 4 mg capsule by mouth single dose per day for 2 months

Drug: lycopene

Prednisolone group

ACTIVE COMPARATOR

Prednisolone- 40 mg capsule by mouth single dose per day for 2 months

Drug: Prednisolone

Interventions

lycopene DRUG

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.

Also known as: lycored

lycopene group

Prednisolone DRUG

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.

Also known as: wysolone

Prednisolone group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Lycopene; Prednisolone

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and 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.

Results Point of Contact

• Title: Dr. Ramayan Prasad Kushwaha
• Organization: B.P. Koirala Institute of Health Sciences

visitramayan007@yahoo.com

977-9842207716

Study Officials

• Ramayan Pr Kushwaha, MD

  B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 27, 2015
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 26, 2016
• Results First Posted: January 26, 2016

Record last verified: 2016-01