Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

NCT ID: NCT02858297

Last Updated: 2016-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-06-30

Brief Summary

Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect and was administrated orally in osteoarthritis and atopic dermatitis therapy. Given the Oral lichen planus (OLP) T-cell-mediated pathogenesis; this drug seems to be a promising therapeutic option. The investigators compared clinical effectiveness of Glucosamine combined with two topical corticosteroid regimens to that of topical corticosteroid alone in symptomatic OLP and investigated therapeutic mechanism by examining treatment effect on expression of inhibitor kappa kinase alpha (IKKα) and interleukin-8 (IL-8) in OLP lesions.

Detailed Description

Thirty patients with Erosive or Atrophic OLP were randomly assigned into Three equal groups to receive combination of topical steroid (triamcinolone acetonide 0.1 %) four times per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks (Group I), combination of topical steroid twice daily and glucosamine sulfate 500 mg orally three times per day for 8 weeks (Group II), or topical steroid alone four times per day for 8 weeks (Group III) all patients were followed up for another treatment free 4 weeks observational period. Photographs of the most severe lesion were taken (Marker lesion) in each patient and analyzed for Total Ulcerative Area (TUA), Total Atrophic Area (TAA), and Total Reticular Area (TRA), patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). Pre-treatment and post-treatment specimens were immunohistochemically stained to detect expression of IKKα and IL-8.

Conditions

Oral Lichen Planus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Glucosamine/Corticosteroid 4

Topical steroid (triamcinolone acetonide 0.1 %) four times per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks

Group Type: EXPERIMENTAL

Glucosamine sulfate

Intervention Type: DRUG

Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect

triamcinolone acetonide

Intervention Type: DRUG

Topical corticosteroid

Glucosamine/Corticosteroid 2

Topical steroid (triamcinolone acetonide 0.1 %) twice per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks

Group Type: EXPERIMENTAL

Glucosamine sulfate

Intervention Type: DRUG

Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect

triamcinolone acetonide

Intervention Type: DRUG

Topical corticosteroid

Corticosteroid

Topical steroid (triamcinolone acetonide 0.1 %) four times per day for 8 weeks

Group Type: ACTIVE_COMPARATOR

triamcinolone acetonide

Intervention Type: DRUG

Topical corticosteroid

Interventions

Glucosamine sulfate

Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect

Intervention Type: DRUG

triamcinolone acetonide

Topical corticosteroid

Intervention Type: DRUG

Other Intervention Names

Kenalog in orabase

Eligibility Criteria

Inclusion Criteria

• Clinically and Histologically proven painful Bullous/erosive or atrophic forms of OLP

Exclusion Criteria

• lichenoid lesions
• Presence of systemic conditions
• Smoking
• Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation
• Pregnancy or breast-feeding
• History of previous treatments potentially effective on OLP in last 3 months
• Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ola Mohamed Ezzatt

Lecturer of oral medicine and periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala A. Abo el ela, Professor

Role: STUDY_DIRECTOR

Faculty of dentistry- Ain shams University

Other Identifiers

FDASU-RECD 1214403

Identifier Type: -

Identifier Source: org_study_id