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
About this trial
This is an interventional treatment trial for Oral Lichen Planus focused on measuring Oral lichen planus, Glucosamine, IL-8
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
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
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
Learn more about this trial
Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus
We'll reach out to this number within 24 hrs