Lichen Penis PlanusNCT04442633
Glutamine With Topical Corticosteroids for Lichen Planus Treatment
A study testing Glutamine Cap/Tab, Miconazole Oral gel and Kenacort in orabase in people with Lichen Penis Planus, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Glutamine promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Lichen Penis Planus
- What is being tested?
- Glutamine Cap/Tab, Miconazole Oral gel and Kenacort in orabase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 1 Jan 2020
- 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 clinically and histopathologically diagnosed to be suffering from EOLP.
- Patients who had symptoms i.e. pain and/or burning sensation secondary to EOLP.
- Patients under stressful life conditions as evidenced by ISMA-UK Stress Questionnaire
- Males and Females with an age ranging from 30-60years
Who cannot join
- Patients suspected to have a lichenoid drug reaction or lichenoid contact allergy.
- Patients suffering from any systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
- Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
About this study
Official title: Clinical Evaluation of Glutamine Combined With Topical Corticosteroids in the Treatment of Erosive Oral Lichen Planus
Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Glutamine promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.
Read the detailed description
Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Recently, increased oxidative stress has been implicated in the pathogenesis of erosive oral lichen planus (EOLP). Glutamine is a source of energy for fibroblasts, immunocompetent cells, and intestinal epithelial cells involved in collagen production. It promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.
The aim of this study is to evaluate the effect of Glutamine combined with topical corticosteroid in the treatment of oral erosive LP.
Thirty patients with a confirmed clinical and histopathologic diagnosis of OLP recruited in this study and divided into 2 equal groups, each consisting of 15 subjects. Group 1 consists of patients treated with topical steroids plus antifungal (conventional therapy); Group 2 consists of patients treated with Glutamine combined with topical steroids plus antifungal.
- Conditions
- Lichen Penis Planus
- Being tested
- Glutamine Cap/Tab, Miconazole Oral gel, Kenacort in orabase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutamine Cap/TabDrug
Glutamine Capsules: One capsule three times daily on an empty stomach for one month
Miconazole Oral gelDrug
Miconazole oral gel: applied three to four times daily for three weeks
Kenacort in orabaseDrug
Kenacort in orabase: applied two to three times a day for 3 weeks followed by tapering the following 9 weeks until a maintenance dose of two to three times a week is reached
| Study group | Role | What they receive |
|---|---|---|
| conventional therapy | Active comparator | topical corticosteroid plus antifungal Receives: Drug: Miconazole Oral gel; Drug: Kenacort in orabase |
| Glutamine with a topical corticosteroid plus antifungal | Experimental | Glutamine therapy in combination with a topical corticosteroid plus antifungal Receives: Drug: Glutamine Cap/Tab; Drug: Miconazole Oral gel; Drug: Kenacort in orabase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oral lichen planus lesions severity
Mucosal lesion severity score 0: no lesion score 1: white lesion score 2:atrophy/erosion intermixed or not with white lesion score 3: ulceration intermixed or not with white lesion
Measured: at baseline, 1 months and 3 months
Secondary outcomes (1)
Change in pain level
Pain score score 0= no pain score 1= mild score 2= moderate score 3= severe
Measured: at baseline, 1 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Apr 2019
- Primary completion1 Aug 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Penis 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
- Outcomes assessor
- Enrolment
- 30 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
- NCT04442633
- Sponsor's protocol ID
- Glutamine and lichen planus
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 22 Jun 2020
- 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 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Glutamine Combined With Topical Corticosteroids in the Treatment of Erosive Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT04442633
- Acronym / sponsor ID
- Glutamine and lichen planus
- Conditions
- Lichen Penis Planus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 22 Jun 2020 (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.
Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Glutamine promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.
Detailed description
Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Recently, increased oxidative stress has been implicated in the pathogenesis of erosive oral lichen planus (EOLP). Glutamine is a source of energy for fibroblasts, immunocompetent cells, and intestinal epithelial cells involved in collagen production. It promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.
The aim of this study is to evaluate the effect of Glutamine combined with topical corticosteroid in the treatment of oral erosive LP.
Thirty patients with a confirmed clinical and histopathologic diagnosis of OLP recruited in this study and divided into 2 equal groups, each consisting of 15 subjects. Group 1 consists of patients treated with topical steroids plus antifungal (conventional therapy); Group 2 consists of patients treated with Glutamine combined with topical steroids plus antifungal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional therapy | Active comparator | Drug: Miconazole Oral gel, Drug: Kenacort in orabasetopical corticosteroid plus antifungal |
| Glutamine with a topical corticosteroid plus antifungal | Experimental | Drug: Glutamine Cap/Tab, Drug: Miconazole Oral gel, Drug: Kenacort in orabaseGlutamine therapy in combination with a topical corticosteroid plus antifungal |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients clinically and histopathologically diagnosed to be suffering from EOLP.
- Patients who had symptoms i.e. pain and/or burning sensation secondary to EOLP.
- Patients under stressful life conditions as evidenced by ISMA-UK Stress Questionnaire
- Males and Females with an age ranging from 30-60years
Key exclusion criteria (3 listed)
- Patients suspected to have a lichenoid drug reaction or lichenoid contact allergy.
- Patients suffering from any systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
- Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
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 |
|---|---|---|
| Glutamine Cap/TabGlutamine Capsules: One capsule three times daily on an empty stomach for one month | Drug | Glutamine with a topical corticosteroid plus antifungal |
| Miconazole Oral gelMiconazole oral gel: applied three to four times daily for three weeks | Drug | Glutamine with a topical corticosteroid plus antifungal, conventional therapy |
| Kenacort in orabaseKenacort in orabase: applied two to three times a day for 3 weeks followed by tapering the following 9 weeks until a maintenance dose of two to three times a week is reached | Drug | Glutamine with a topical corticosteroid plus antifungal, conventional therapy |
Primary outcome
Change in oral lichen planus lesions severity
Time frame: at baseline, 1 months and 3 months
Mucosal lesion severity score 0: no lesion score 1: white lesion score 2:atrophy/erosion intermixed or not with white lesion score 3: ulceration intermixed or not with white lesion
1 secondary outcome
Change in pain level
Time frame: at baseline, 1 months and 3 months
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 22 Jun 2020.
Related trials for 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 Glutamine Cap/Tab, Miconazole Oral gel and Kenacort in orabase in people with Lichen Penis 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 4 inclusion and 3 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 22 Jun 2020. 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 lichen planus lesions severity (time frame: at baseline, 1 months and 3 months). 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 22 Jun 2020.