Oral Lichen Planus
Conditions
Keywords
Oral lichen planus, Glucosamine, IL-8
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.
Interventions
Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect
DRUGtriamcinolone acetonide
Topical corticosteroid
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical score | change from Baseline at 12 weeks | 0 represented no lesion/normal mucosa; 1 mild white striae/no erythematous area, 2white 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IKK-alpha | change from baseline at 8 weeks | Inhibitor kappa kinase alpha immunopositive cells count in immunostained section |
Other
| Measure | Time frame | Description |
|---|---|---|
| VAS | change from Baseline at 12 weeks | Patients ranked the severity of pain on 100-mm visual analog scale |
| TUA | change from Baseline at 12 weeks | Surface area of ulcer in marker lesion in mm2 |
| TAA | change from Baseline at 12 weeks | Surface area of atrophied red area in marker lesion in mm2 |
| IL-8 | change from baseline at 8 weeks | Mean area fraction of immunopositive IL-8 in section |
Outcome results
None listed