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Trial record 17 of 18 for:    Atrophic Lichen Planus

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04126720
Recruitment Status : Completed
First Posted : October 15, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Engy Mahmoud Abdel Wahed Abdel dayem, Cairo University

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.


Condition or disease Intervention/treatment Phase
Oral Lichen Planus Dietary Supplement: topical corticosteroids and vitamin E suplements Drug: Topical corticosteroid and placebo capsules Phase 1

Detailed Description:

The current study is a randomized-controlled clinical trial that follows CONSORT guideline. The current trial include 30 symptomatic OLP patients in two parallel groups (intervention - topical triamcinolone acetonide adhesive paste and Vitamin E capsule, control - topical triamcinolone acetonide adhesive paste and placebo capsule), with allocation ratio 1:1. Participants were recruited from the pool of the Diagnostic center and the Out-Patient Clinic of Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University, Egypt between 2016 and 2017.

This clinical trial followed the principles of the Helsinki Declaration and was approved by the Research ethics committee of Faculty of Dentistry, Cairo University, Egypt (Code: 15733). Each participant was informed about the details of the study and signed a written consent.

Patients were diagnosed clinically and histopathologically (when required). Inclusion criteria included erosive and atrophic OLP patients who agreed to take supplied medications. Exclusion criteria included reticular OLP patients, patients receiving systemic treatment for OLP during the eight weeks prior to the study, patients receiving topical medications for OLP during the four weeks prior to the study, patients suffering from systemic disease; pregnant ladies and lactating ladies.

Interventions:

The intervention was 0.1% triamcinolone acetonide adhesive paste (Kenacort A Orabase - Dermapharm) and 400 mg Vitamin E capsule (Vitamin E 400 - Pharopharmaceuticles) for the experimental group and 0.1% triamcinolone acetonide adhesive paste (Kenacort A Orabase - Dermapharm) and identical placebo capsule for the control group.

Patients were instructed to apply triamcinolone acetonide regularly four times a day after meals and before sleeping for four weeks and to refrain eating and drinking for 30 minutes after the application. In addition, patients were asked to take one capsule (Vitamin E or placebo) once daily at morning.

Outcomes:

Pain intensity was evaluated using numerical rating scale (NRS) at baseline, daily during the first week, then weekly for four weeks. NRS ranges from 0 to 10, with 0 indicating "no pain" and 10 indicating "pain as bad as you can imagine".21 Clinical improvement of the oral lesions was scored using Thongprasom et al. scale at baseline and weekly for four weeks. In Thongprasom et al. scale, lesions are given score as follows: 0, no lesions, normal mucosa; 1, Mild white striae, no erythematous area; 2, White striae with atrophic area < 1 cm2; 3, White striae with atrophic area > 1 cm2; 4, White striae with erosive area < 1 cm2 and 5, White striae with erosive area > 1 cm2.22 Salivary level of TAC was evaluated using ELISA kit. Unstimulated whole saliva samples were used for determination of TAC using ImAnOx (TAS/TAC) Kit provided by Immun Diagnostik, Germany. Participants were asked to refrain eating, drinking or using saliva stimulators for one hour before sample collection. Participants were asked to swallow, then tilt their head forward and expectorate saliva into a centrifuge tubes for 5 minutes without swallowing. The saliva samples were frozen at -70°C, until analysis. The saliva samples were centrifuged at 4500 g for 15 minutes.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Salivary Total Oxidant Capacity in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid Supplemented With Vitamin E Versus Topical Corticosteroid Alone
Actual Study Start Date : January 22, 2016
Actual Primary Completion Date : April 25, 2017
Actual Study Completion Date : November 12, 2017


Arm Intervention/treatment
Active Comparator: vitamin E
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 Comparator: Placebo
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



Primary Outcome Measures :
  1. Pain measure using numerical rating scale [ Time Frame: weekly for 1 month ]
    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


Secondary Outcome Measures :
  1. Clinical improvement of the lesion [ Time Frame: weekly for 1 month ]
    The clinical data will be scored according to the scale used by Thongprasom et al.: 0, no lesions; 1, hyperkeratotic lesions; 2, atrophic area <1 cm2; 3, atrophic area > 1 cm2; 4, erosive area < 1 cm2; 5, erosive area >1 cm2

  2. salivary total anti-oxidant capacity [ Time Frame: Preoperative and postoperative ]
    using the ELISA



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126720


Locations
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Egypt
Faculty of Dentistry Cairo University
Giza, Egypt, 12345
Sponsors and Collaborators
Cairo University

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Responsible Party: Engy Mahmoud Abdel Wahed Abdel dayem, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT04126720     History of Changes
Other Study ID Numbers: ED412018
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents