Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Oral Lichen Planus

Treatments: Drug: triamcinolone acetonide; Drug: Glucosamine sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT02858297

FDASU-RECD 1214403

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Glucosamine/Corticosteroid 4

Experimental group

Description:

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

Treatment:

Drug: Glucosamine sulfate

Drug: triamcinolone acetonide

Glucosamine/Corticosteroid 2

Experimental group

Description:

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

Treatment:

Drug: Glucosamine sulfate

Drug: triamcinolone acetonide

Corticosteroid

Active Comparator group

Description:

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

Treatment:

Drug: triamcinolone acetonide