Effect of Adjunctive Systemic Vitamin E on Clinical Parameters and Salivary Total Antioxidant Capacity in Symptomatic Oral Lichen Planus Patients: Randomized-controlled Clinical Trial

NCT04126720 | Completed Phase 1 DMC

• 1 other identifier: ED412018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available. In some oral lichen planus patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect. This trial will assess the effectiveness of vitamin E as a supplement in management of oral lichen planus.

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• Pain measure using numerical rating scale

  All patients will be asked to define their level of pain and discomfort by using a numerical rating scale ranging from 0 to 10 (11-point), with 0 indicating "no pain" and 10 indicating "pain as bad as you can imagine

  weekly for 1 month

Secondary Outcomes (2)

• Clinical improvement of the lesion

  weekly for 1 month

• salivary total anti-oxidant capacity

  Preoperative and postoperative

Study Arms (2)

vitamin E

ACTIVE COMPARATOR

topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% 5 gram adhesive paste - Dermapharm) four times daily and Vitamin E capsule (Vitamin E 400: 400 mg vitamin E capsules - Pharopharmaceuticles) daily.

Dietary Supplement: topical corticosteroids and vitamin E suplements

Placebo

PLACEBO COMPARATOR

topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% 5 gram adhesive paste - Dermapharm) four times daily and placebo capsule daily

Drug: Topical corticosteroid and placebo capsules

Interventions

topical corticosteroids and vitamin E suplements DIETARY_SUPPLEMENT

vitamin E

Topical corticosteroid and placebo capsules DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients clinically and histopathologically diagnosed as suffering from OLP (erosive and atrophic OLP patients who agreed to take supplied medications).
• Patients free from any visible oral lesions other than OLP.
• Patients who agreed to take supplied medications.
• Patients who agreed for the biopsy

You may not qualify if:

• Reticular OLP patients
• Patients suffering from any systemic disease.
• Patients Treated with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
• Treatment with any oral topical medications for at least four weeks prior to the study.
• Pregnant and lactating mothers

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Giza, 12345, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 15, 2019
• Study Start: January 22, 2016
• Primary Completion: April 25, 2017
• Study Completion: November 12, 2017
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)