Lichen PlanusNCT05787925
Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level in Patients With Erosive Oral Lichen Planus
A study testing Topical corticosteroid and Vitamin E and Topical corticosteroid in people with Lichen Planus, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Oral lichen planus (OLP) is a chronic inflammatory disease affecting the skin, mucous membranes,s and rarely scalp and nails. It is a T-cell-mediated autoimmune disease. Traditional treatment for OLP is topical steroids commonly used to treat mild to moderately symptomatic lesions. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Lichen Planus
- What is being tested?
- Topical corticosteroid and Vitamin E and Topical corticosteroid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2022to 5 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are clinically and histopathologically confirmed of having erosive OLP according to modified WHO criteria.
- Patients with erosive OLP patients who will agree to take supplied medications.
- Ability to complete this trial.
Who cannot join
- OLP patients receiving any systemic treatment such as systemic steroids, other immunosuppressive drugs, or non-steroidal anti-inflammatory drugs on past 3 months.
- Pregnant and breast-feeding females.
- Patients suffering from systemic diseases.
- Patients with lesions showing any dysplastic changes in the biopsy specimen.
- Patients who are smoking and tobacco users in any form, will not be included.
- Patients with both lichenoid contact reaction and lichenoid drug reactions.
- Patients with cutaneous lichen planus lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level In Patients With Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)
Oral lichen planus (OLP) is a chronic inflammatory disease affecting the skin, mucous membranes,s and rarely scalp and nails. It is a T-cell-mediated autoimmune disease. Traditional treatment for OLP is topical steroids commonly used to treat mild to moderately symptomatic lesions. Recent treatment modalities for oral lichen planus include micronutrients such as antioxidants including vitamin E that modify the immune system function. The aim of this study is to evaluate the efficacy of adjunctive oral systemic vitamin E therapy on salivary nitric oxide levels in patients with erosive oral lichen planus.
- Conditions
- Lichen Planus
- Being tested
- Topical corticosteroid and Vitamin E, Topical corticosteroid
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical corticosteroid and Vitamin EDrug
26 patients who will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel "Kenacort-A Orabase" * three times daily for 8 weeks applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application. In addition to one capsule of 400 mg oral systemic vitamin E supplement* will be prescribed once daily at the morning
Topical corticosteroidDrug
26 patients will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel "Kenacort-A Orabase" three times daily for 8 week that will be applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application
| Study group | Role | What they receive |
|---|---|---|
| Topical corticosteroid and Vitamin E | Experimental | Not described Receives: Drug: Topical corticosteroid and Vitamin E |
| Topical corticosteroid | Active comparator | Not described Receives: Drug: Topical corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oral lesion
whole treatment response and the size of the oral lesions will be recorded using Thongprasom et al. scoring system, score 5 was assigned to patients having white striae with erosive areas >1 cm2, score 4 for patients with white striae and erosive areas <1 cm2, score 3 for those having white striae and atrophic areas >1 cm2, score 2 for those having white striae and atrophic areas <1 cm2, score 1 for those having only white striae, and score 0 for normal mucosa
Measured: At baseline,4th week and 8th week
Change in pain score
At baseline, 4th week and 8th week after the treatment, burning sensation using Visual Analogue Scale (VAS) will be measured on a 10-point (0 = no symptoms, 10 = severe pain)
Measured: At baseline,4th week and 8th week
Secondary outcomes (1)
Change in salivary nitric oxide
Patients will be asked to rinse their mouth with 5 ml of normal saline for 3 min then tilt their head forward and expectorate saliva into a sterile beaker without swallowing. The saliva samples will be stored at -20 ºC till the time of analysis. It depends on the addition of Griess Reagents which convert nitrite into a deep purple azo compound; photometric measurement of the absorbance due to this azo chromophore accurately determines NO2-concentration
Measured: At baseline,4th week and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start20 Oct 2022
- Primary completion5 Mar 2023
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787925
- Sponsor's protocol ID
- 0475-08
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level In Patients With Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05787925
- Acronym / sponsor ID
- 0475-08
- Conditions
- Lichen Planus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral lichen planus (OLP) is a chronic inflammatory disease affecting the skin, mucous membranes,s and rarely scalp and nails. It is a T-cell-mediated autoimmune disease. Traditional treatment for OLP is topical steroids commonly used to treat mild to moderately symptomatic lesions. Recent treatment modalities for oral lichen planus include micronutrients such as antioxidants including vitamin E that modify the immune system function. The aim of this study is to evaluate the efficacy of adjunctive oral systemic vitamin E therapy on salivary nitric oxide levels in patients with erosive oral lichen planus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical corticosteroid and Vitamin E | Experimental | Drug: Topical corticosteroid and Vitamin E |
| Topical corticosteroid | Active comparator | Drug: Topical corticosteroid |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who are clinically and histopathologically confirmed of having erosive OLP according to modified WHO criteria.
- Patients with erosive OLP patients who will agree to take supplied medications.
- Ability to complete this trial.
Key exclusion criteria (7 listed)
- OLP patients receiving any systemic treatment such as systemic steroids, other immunosuppressive drugs, or non-steroidal anti-inflammatory drugs on past 3 months.
- Pregnant and breast-feeding females.
- Patients suffering from systemic diseases.
- Patients with lesions showing any dysplastic changes in the biopsy specimen.
- Patients who are smoking and tobacco users in any form, will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical corticosteroid and Vitamin E26 patients who will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel "Kenacort-A Orabase" * three times daily for 8 weeks applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application. In addition to one capsule of 400 mg oral systemic vitamin E supplement* will be prescribed once daily at the morning | Drug | Topical corticosteroid and Vitamin E |
| Topical corticosteroid26 patients will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel "Kenacort-A Orabase" three times daily for 8 week that will be applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application | Drug | Topical corticosteroid |
Primary outcome
Change in oral lesion
Time frame: At baseline,4th week and 8th week
whole treatment response and the size of the oral lesions will be recorded using Thongprasom et al. scoring system, score 5 was assigned to patients having white striae with erosive areas >1 cm2, score 4 for patients with white striae and erosive areas <1 cm2, score 3 for those having white striae and atrophic areas >1 cm2, score 2 for those having white striae and atrophic areas <1 cm2, score 1 for those having only white striae, and score 0 for normal mucosa
Change in pain score
Time frame: At baseline,4th week and 8th week
At baseline, 4th week and 8th week after the treatment, burning sensation using Visual Analogue Scale (VAS) will be measured on a 10-point (0 = no symptoms, 10 = severe pain)
1 secondary outcome
Change in salivary nitric oxide
Time frame: At baseline,4th week and 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
Related trials for Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus
Cutaneous Lichen Planus
RecruitingPhase 2
Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study.
Lichen Penis Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical corticosteroid and Vitamin E and Topical corticosteroid in people with Lichen Planus, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in oral lesion (time frame: At baseline,4th week and 8th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.