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Completed

NCT Number: NCT02858297

Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

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.

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Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucosamine Sulfate

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

Drug

Topical corticosteroid

Other names: Kenalog in orabase

Primary outcomes

  1. Clinical score

    Time frame: change from Baseline at 12 weeks

    "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

Secondary outcomes

  1. IKK-alpha

    Time frame: change from baseline at 8 weeks

    Inhibitor kappa kinase alpha immunopositive cells count in immunostained section

Other outcomes

  1. VAS

    Time frame: change from Baseline at 12 weeks

    Patients ranked the severity of pain on 100-mm visual analog scale

  2. TUA

    Time frame: change from Baseline at 12 weeks

    Surface area of ulcer in marker lesion in mm2

  3. TAA

    Time frame: change from Baseline at 12 weeks

    Surface area of atrophied red area in marker lesion in mm2

  4. IL-8

    Time frame: change from baseline at 8 weeks

    Mean area fraction of immunopositive IL-8 in section

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2016
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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