Clinical and Biochemical Assessment of the Effect of Topical Use of Coenzyme Q10 Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Randomized Controlled Clinical Trial

NCT04091698 | Unknown Phase 1

• 1 other identifier: Q10 in oral lichen planus
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present investigation is to assess the clinical therapeutic effect of topical use of Coenzyme Q10 versus topical corticosteroid in management of symptomatic oral lichen planus and determine whether the effect, if any, was due to its antioxidant activity.

Conditions

Oral Lichen Planus

Keywords

co enzymeQ10 - Antioxidant- Corticosteroids

Outcome Measures

Primary Outcomes (2)

• pain score

  visual analogue scale scoring system

  3months

• clinical size of lesion

  Thongprasom score system

  3months

Secondary Outcomes (1)

• Salivary level of Malondialdehyde

  3months

Study Arms (2)

topical Q10 mucoadhesive tablets

ACTIVE COMPARATOR

will receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months.

Drug: Co-Enzyme Q10 mucoadhesive tablets

topical corticosteroid

PLACEBO COMPARATOR

will receive topical corticosteroid (kenacort A Orabase: triamcinolone acetonide 0.1%5gram adhesive paste - dermapharm), 4 times daily for 3months.

Drug: Co-Enzyme Q10 mucoadhesive tablets

Interventions

Co-Enzyme Q10 mucoadhesive tablets DRUG

will receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months.

Also known as: Q10 mucoadhesive tablets -ubiquinol

topical Q10 mucoadhesive tablets; topical corticosteroid

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients free from any systemic disease according to the detailed questionnaire of the modified Cornell Medical Index 34.
• Patients not receiving any medication either topical or systemic that could cause lichenoid reaction during the 3 months before the study.
• Patients diagnosed by a dermatologist and oral medicine specialist as suffering from OLP.
• Patients clinically and histopathologically diagnosed as suffering from OLP according to World Health Organization's (WHO's) clinic-pathological diagnostic criteria for LP35.
• Patients who agree for the biopsy in undiagnosed cases.
• Patients who are willing to participate in this study (will give informed consent) and have the ability to complete the study.

You may not qualify if:

• (1) Patients taking systemic drugs such as systemic steroid, other immunosuppressive therapy for at least 8 weeks prior to the study.
• (2) Patients treated with any oral topical medications for at least four weeks prior to the study.
• (3) Patients with suspected restoration-related reaction. (4) Pregnant and lactating mothers.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (6)

• Scrobota I, Mocan T, Catoi C, Bolfa P, Muresan A, Baciut G. Histopathological aspects and local implications of oxidative stress in patients with oral lichen planus. Rom J Morphol Embryol. 2011;52(4):1305-9.

  PMID: 22203938 BACKGROUND

• Sugerman PB, Savage NW, Zhou X, Walsh LJ, Bigby M. Oral lichen planus. Clin Dermatol. 2000 Sep-Oct;18(5):533-9. doi: 10.1016/s0738-081x(00)00142-5. No abstract available.

  PMID: 11134848 BACKGROUND

• Ismail SB, Kumar SK, Zain RB. Oral lichen planus and lichenoid reactions: etiopathogenesis, diagnosis, management and malignant transformation. J Oral Sci. 2007 Jun;49(2):89-106. doi: 10.2334/josnusd.49.89.

  PMID: 17634721 BACKGROUND

• Bhagavan HN, Chopra RK. Plasma coenzyme Q10 response to oral ingestion of coenzyme Q10 formulations. Mitochondrion. 2007 Jun;7 Suppl:S78-88. doi: 10.1016/j.mito.2007.03.003. Epub 2007 Mar 27.

  PMID: 17482886 BACKGROUND

• Yang LL, Liu XQ, Liu W, Cheng B, Li MT. Comparative analysis of whole saliva proteomes for the screening of biomarkers for oral lichen planus. Inflamm Res. 2006 Oct;55(10):405-7. doi: 10.1007/s00011-006-5145-8.

  PMID: 16850138 BACKGROUND

• Abdelsamie M, Zahran F, Hussine AA, Shaker O, Al-Mahallawi AM. Clinical and biochemical assessment of the effect of topical use of coenzyme Q10 versus topical corticosteroid in management of symptomatic oral lichen planus: randomized controlled clinical trial. BMC Oral Health. 2023 Jul 21;23(1):506. doi: 10.1186/s12903-023-03206-5.

  PMID: 37480004 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

ubiquinol

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

mostafa abdelsamie, demonstrator

CONTACT

01004165905; mostafa.abdelsamie@dentistry.cu.edu.eg

fatheya zahran, professor

CONTACT

fatheya.zahran@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double-blinded trial, outcome assessors and statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator

Model Details: two parallel group one take Q10 mucoadhesive tablets and other take topical corticosteroid for 3 months follow up measuring pain ,clinical size of lesion and salivary level of Malondialdehyde as oxidative biomarker

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 17, 2019

Record last verified: 2019-09