Clinical trial NCT02858297: Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus
Official title: Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus: A Pilot, Randomized, Clinical and Immunohistochemical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Lichen Planus
Keywords: Oral lichen planus
Glucosamine
IL-8
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical score
timeFrame: change from Baseline at 12 weeks
Secondary outcomes:
measure: IKK-alpha
timeFrame: change from baseline at 8 weeks
Other outcomes:
measure: VAS
timeFrame: change from Baseline at 12 weeks
measure: TUA
timeFrame: change from Baseline at 12 weeks
measure: TAA
timeFrame: change from Baseline at 12 weeks
measure: IL-8
timeFrame: change from baseline at 8 weeks
Locations:
Study officials:
affiliation: Faculty of dentistry- Ain shams University
name: Hala A. Abo el ela, Professor
role: STUDY_DIRECTOR
References: