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Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

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ClinicalTrials.gov Identifier: NCT02858297
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Ola Mohamed Ezzatt, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: Glucosamine sulfate Drug: triamcinolone acetonide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus: A Pilot, Randomized, Clinical and Immunohistochemical Trial
Study Start Date : May 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


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 Name: 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 Name: 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 Name: Kenalog in orabase




Primary Outcome Measures :
  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 Outcome Measures :
  1. IKK-alpha [ Time Frame: change from baseline at 8 weeks ]
    Inhibitor kappa kinase alpha immunopositive cells count in immunostained section


Other Outcome Measures:
  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



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858297


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Hala A. Abo el ela, Professor Faculty of dentistry- Ain shams University

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Responsible Party: Ola Mohamed Ezzatt, Lecturer of oral medicine and periodontology, Ain Shams University
ClinicalTrials.gov Identifier: NCT02858297     History of Changes
Other Study ID Numbers: FDASU-RECD 1214403
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ola Mohamed Ezzatt, Ain Shams University:
Oral lichen planus
Glucosamine
IL-8
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action