Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

Oral Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858297
• Other study ID #: FDASU-RECD 1214403
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2016
• Last updated: August 3, 2016
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

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
• triamcinolone acetonide
Topical corticosteroid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VAS	Patients ranked the severity of pain on 100-mm visual analog scale	change from Baseline at 12 weeks	Yes
Other	TUA	Surface area of ulcer in marker lesion in mm2	change from Baseline at 12 weeks	Yes
Other	TAA	Surface area of atrophied red area in marker lesion in mm2	change from Baseline at 12 weeks	Yes
Other	IL-8	Mean area fraction of immunopositive IL-8 in section	change from baseline at 8 weeks	Yes
Primary	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	Yes
Secondary	IKK-alpha	Inhibitor kappa kinase alpha immunopositive cells count in immunostained section	change from baseline at 8 weeks	Yes