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Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

Primary Purpose

Oral Lichen Planus

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Glucosamine sulfate
triamcinolone acetonide
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring Oral lichen planus, Glucosamine, IL-8

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Glucosamine/Corticosteroid 4

    Glucosamine/Corticosteroid 2

    Corticosteroid

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    IKK-alpha
    Inhibitor kappa kinase alpha immunopositive cells count in immunostained section

    Full Information

    First Posted
    July 26, 2016
    Last Updated
    August 3, 2016
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02858297
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Lichen Planus
    Keywords
    Oral lichen planus, Glucosamine, IL-8

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glucosamine/Corticosteroid 4
    Arm Type
    Experimental
    Arm Description
    Topical steroid (triamcinolone acetonide 0.1 %) four times per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks
    Arm Title
    Glucosamine/Corticosteroid 2
    Arm Type
    Experimental
    Arm Description
    Topical steroid (triamcinolone acetonide 0.1 %) twice per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks
    Arm Title
    Corticosteroid
    Arm Type
    Active Comparator
    Arm Description
    Topical steroid (triamcinolone acetonide 0.1 %) four times per day for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Glucosamine sulfate
    Intervention Description
    Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect
    Intervention Type
    Drug
    Intervention Name(s)
    triamcinolone acetonide
    Other Intervention Name(s)
    Kenalog in orabase
    Intervention Description
    Topical corticosteroid
    Primary Outcome Measure Information:
    Title
    Clinical score
    Description
    "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
    Time Frame
    change from Baseline at 12 weeks
    Secondary Outcome Measure Information:
    Title
    IKK-alpha
    Description
    Inhibitor kappa kinase alpha immunopositive cells count in immunostained section
    Time Frame
    change from baseline at 8 weeks
    Other Pre-specified Outcome Measures:
    Title
    VAS
    Description
    Patients ranked the severity of pain on 100-mm visual analog scale
    Time Frame
    change from Baseline at 12 weeks
    Title
    TUA
    Description
    Surface area of ulcer in marker lesion in mm2
    Time Frame
    change from Baseline at 12 weeks
    Title
    TAA
    Description
    Surface area of atrophied red area in marker lesion in mm2
    Time Frame
    change from Baseline at 12 weeks
    Title
    IL-8
    Description
    Mean area fraction of immunopositive IL-8 in section
    Time Frame
    change from baseline at 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hala A. Abo el ela, Professor
    Organizational Affiliation
    Faculty of dentistry- Ain shams University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

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