NCT02858297

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2015

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

1.1 years

First QC Date

July 26, 2016

Last Update Submit

August 3, 2016

Conditions

Oral Lichen Planus

Keywords

Oral lichen planusGlucosamineIL-8

Outcome Measures

Primary Outcomes (1)

  • 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

    change from Baseline at 12 weeks

Secondary Outcomes (1)

  • IKK-alpha

    change from baseline at 8 weeks

Other Outcomes (4)

  • VAS

    change from Baseline at 12 weeks

  • TUA

    change from Baseline at 12 weeks

  • TAA

    change from Baseline at 12 weeks

  • +1 more other outcomes

Study Arms (3)

Glucosamine/Corticosteroid 4

EXPERIMENTAL

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 sulfateDrug: triamcinolone acetonide

Glucosamine/Corticosteroid 2

EXPERIMENTAL

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

Drug: Glucosamine sulfateDrug: triamcinolone acetonide

Corticosteroid

ACTIVE COMPARATOR

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

Drug: triamcinolone acetonide

Interventions

Glucosamine sulfateDRUG

Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect

Glucosamine/Corticosteroid 2Glucosamine/Corticosteroid 4
triamcinolone acetonideDRUG

Topical corticosteroid

Also known as: Kenalog in orabase
CorticosteroidGlucosamine/Corticosteroid 2Glucosamine/Corticosteroid 4

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically and Histologically proven painful Bullous/erosive or atrophic forms of OLP

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

GlucosamineTriamcinolone AcetonideTriamcinolone

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

HexosaminesAmino SugarsCarbohydratesPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Hala A. Abo el ela, Professor

    Faculty of dentistry- Ain shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of oral medicine and periodontology

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 8, 2016

Study Start

May 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-08