Phase 4 N=28 Randomized Quadruple-blind Treatment

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

Oral Lichen Planus

Bottom Line

View on ClinicalTrials.gov: NCT02587117 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2016

Primary outcome: Primary: Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score — 2.15; 0.73 Scores on a scale — p=0.004

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: lycopene (Drug); Prednisolone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: B.P. Koirala Institute of Health Sciences
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score	2.15; 0.73	0.004 sig
SECONDARY Burning Sensation or Pain by Using NRS (Numerical Rating Scale)	0.23; 0.07	0.224

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02587117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.