Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus: A Pilot, Randomized, Clinical and Immunohistochemical Trial

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.

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Glucosamine sulfate; Drug: triamcinolone acetonide

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: 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; Drug: triamcinolone acetonide; Topical corticosteroid; Other Names: Kenalog in orabase
EXPERIMENTAL: 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	Drug: 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; Drug: triamcinolone acetonide; Topical corticosteroid; Other Names: Kenalog in orabase
ACTIVE_COMPARATOR: Corticosteroid; Topical steroid (triamcinolone acetonide 0.1 %) four times per day for 8 weeks	Drug: triamcinolone acetonide; Topical corticosteroid; Other Names: Kenalog in orabase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical score	"0" represented no lesion/normal mucosa; "1" mild white striae/no erythematous area, "2"white striae with atrophic area less than 1 cm², "3" white striae with atrophic area more than 1 cm², "4" white striae with erosive area less than 1 cm², and "5" white striae with erosive area more than 1 cm²	change from Baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IKK-alpha	Inhibitor kappa kinase alpha immunopositive cells count in immunostained section	change from baseline at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	Patients ranked the severity of pain on 100-mm visual analog scale	change from Baseline at 12 weeks
TUA	Surface area of ulcer in marker lesion in mm2	change from Baseline at 12 weeks
TAA	Surface area of atrophied red area in marker lesion in mm2	change from Baseline at 12 weeks
IL-8	Mean area fraction of immunopositive IL-8 in section	change from baseline at 8 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Hala A. Abo el ela, professor, Faculty of Dentistry- Ain Shams University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (ESTIMATE): August 8, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 8, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: IL-8; Glucosamine; Oral lichen planus
• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: FDASU-RECD 1214403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED