Degree of Adherence of Symptomatic OLP Patients to Their MedicationsNCT07879300
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
A study testing standard verbal instructions, Explanatory leaflets and text msgs in people with Degree of Adherence of Symptomatic OLP Patients to Their Medications, run by Cairo University at 1 site in Egypt.
Trial summary
This trial will assess the effect of adjunctive use of explanatory leaflet or daily text message reminder compared to standard instructions alone in degree of adherence of symptomatic OLP patients to their medications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degree of Adherence of Symptomatic OLP Patients to Their Medications
- What is being tested?
- standard verbal instructions, Explanatory leaflets and text msgs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2026to 15 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suffering from symptomatic OLP.
- Patients who agree to take the medications.
- Patients able to provide written informed consent.
- Patients who possess a mobile phone.
Who cannot join
- Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks prior to the study.
- Treatment with any oral topical medications for at least four weeks prior to the study.
- Pregnant and lactating mothers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yasmine Nasir El-Alami, Master's degree student contact
Egypt1 site
Cairo University-Faculty of Oral and Dental Medicine
Cairo
Shereen Hassan, PhD, +20 2 23634965, Shereen.ali@dentistry.cu.edu.eg
About this study
This trial will assess the effect of adjunctive use of explanatory leaflet or daily text message reminder compared to standard instructions alone in degree of adherence of symptomatic OLP patients to their medications.
Read the detailed description
Symptomatic OLP poses therapeutic challenges due to its chronicity; repeated medication application, prolonged contact time, and sustained use of topical and systemic therapies over weeks or months. Poor adherence is a barrier to symptom control. Adherence is affected by regimen complexity, concerns about corticosteroid use, inconvenience, and patient frustration with recurrence .The aim of the present study is to assess the effect of adjunctive use of explanatory leaflet or daily text message reminder compared to standard instructions alone in degree of adherence of symptomatic oral lichen planus (OLP) patients to their medications.
- Being tested
- standard verbal instructions, Explanatory leaflets, text msgs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard verbal instructionsBehavioural
this will be applied to all three groups
Explanatory leafletsBehavioural
Explanatory leaflet; the instructions augmented with patient education regarding the nature of the disease, objectives of the treatment, form of the medication and expected adverse effects during the first visit
text msgsBehavioural
daily text message reminder to apply the medicine
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1: Explanatory leaflet + Standard instructions | Experimental | One group will receive standard instructions augmented with patient education regarding the nature of the disease, objectives of the treatment, form of the medication and expected adverse effects during the first visit. Topical Corticosteroid will be prescribed four times daily or Systemic Corticosteroid will be prescribed once daily according to condition Receives: Behavioral: standard verbal instructions; Behavioral: Explanatory leaflets |
| Intervention 2 : Daily text message reminder + Standard instructions | Experimental | The second group will receive standard instructions augmented with daily text message reminder. Topical Corticosteroid will be prescribed four times daily and Systemic Corticosteroid will be prescribed once daily according to condition. Receives: Behavioral: standard verbal instructions; Behavioral: text msgs |
| Comparison [C]: Standard instructions | Active comparator | The third group will receive standard instructions. Topical Corticosteroid will be prescribed four times daily and Systemic Corticosteroid will be prescribed once daily according to the condition. Receives: Behavioral: standard verbal instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of adherence [objective assessment] will be assessed by weighing tubes or counting pills.
Objective adherence assessments by weighing tubes or counting pills provide a reliable and accurate measure of patient behavior.
Measured: from enrollment to the end of treatment at 4 weeks
Secondary outcomes (3)
Degree of adherence [subjective assessment] will be reported by patients using Morisky Medication Adherence Scale
Degree of adherence will be reported by patients using Morisky Medication Adherence Scale at baseline, weekly for 4 weeks or till healing. Morisky Medication Adherence Scale captures medication-taking behaviors and identify common barriers to adherence.
Measured: At baseline, weekly for 4 weeks or till healing. (From enrollment to the end of treatment at 4 weeks)
Pain intensity will be measured using Visual analogue scale (VAS).
Pain intensity will be measured using Visual analogue scale (VAS), VAS is a self-reported pain score ranging from 0 to 10 at baseline, daily for the first week, then weekly for the remaining 3 weeks or till healing.
Measured: At baseline, daily for the first week, then weekly for the remaining 3 weeks or till healing (From enrollment to the end of treatment at 4 weeks).
Clinical improvement will be measured using Thongprasom et al. scoring system.
Clinical improvement will be measured using Thongprasom et al. scoring system at baseline, and weekly for 4 weeks or till healing. Thongprasom et al. scale scores lesions 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.
Measured: At baseline, and weekly for 4 weeks or till healing. (From enrollment to the end of treatment at 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degree of Adherence of Symptomatic OLP Patients to Their MedicationsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized clinical trial (RCT) parallel groups, three arms, equivalence framework with 1:1:1 allocation ratio
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine El Alami, Cairo University
- Investigators
- Shereen A Hassan, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879300
- Sponsor's protocol ID
- OMED 3-7-1
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07879300
- Acronym / sponsor ID
- OMED 3-7-1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 16 Oct 2026 (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.
This trial will assess the effect of adjunctive use of explanatory leaflet or daily text message reminder compared to standard instructions alone in degree of adherence of symptomatic OLP patients to their medications.
Detailed description
Symptomatic OLP poses therapeutic challenges due to its chronicity; repeated medication application, prolonged contact time, and sustained use of topical and systemic therapies over weeks or months. Poor adherence is a barrier to symptom control. Adherence is affected by regimen complexity, concerns about corticosteroid use, inconvenience, and patient frustration with recurrence .The aim of the present study is to assess the effect of adjunctive use of explanatory leaflet or daily text message reminder compared to standard instructions alone in degree of adherence of symptomatic oral lichen planus (OLP) patients to their medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized clinical trial (RCT) parallel groups, three arms, equivalence framework with 1:1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Intervention 1: Explanatory leaflet + Standard instructions | Experimental | Behavioral: standard verbal instructions, Behavioral: Explanatory leafletsOne group will receive standard instructions augmented with patient education regarding the nature of the disease, objectives of the treatment, form of the medication and expected adverse effects during the first visit. Topical Corticosteroid will be prescribed four times daily or Systemic Corticosteroid will be prescribed once daily according to condition |
| Intervention 2 : Daily text message reminder + Standard instructions | Experimental | Behavioral: standard verbal instructions, Behavioral: text msgsThe second group will receive standard instructions augmented with daily text message reminder. Topical Corticosteroid will be prescribed four times daily and Systemic Corticosteroid will be prescribed once daily according to condition. |
| Comparison [C]: Standard instructions | Active comparator | Behavioral: standard verbal instructionsThe third group will receive standard instructions. Topical Corticosteroid will be prescribed four times daily and Systemic Corticosteroid will be prescribed once daily according to the condition. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suffering from symptomatic OLP.
- Patients who agree to take the medications.
- Patients able to provide written informed consent.
- Patients who possess a mobile phone.
Key exclusion criteria (3 listed)
- Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks prior to the study.
- Treatment with any oral topical medications for at least four weeks prior to the study.
- Pregnant and lactating mothers.
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 |
|---|---|---|
| standard verbal instructionsthis will be applied to all three groups | Behavioural | Comparison [C]: Standard instructions, Intervention 1: Explanatory leaflet + Standard instructions, Intervention 2 : Daily text message reminder + Standard instructions |
| Explanatory leafletsExplanatory leaflet; the instructions augmented with patient education regarding the nature of the disease, objectives of the treatment, form of the medication and expected adverse effects during the first visit | Behavioural | Intervention 1: Explanatory leaflet + Standard instructions |
| text msgsdaily text message reminder to apply the medicine | Behavioural | Intervention 2 : Daily text message reminder + Standard instructions |
Primary outcome
Degree of adherence [objective assessment] will be assessed by weighing tubes or counting pills.
Time frame: from enrollment to the end of treatment at 4 weeks
Objective adherence assessments by weighing tubes or counting pills provide a reliable and accurate measure of patient behavior.
3 secondary outcomes
Degree of adherence [subjective assessment] will be reported by patients using Morisky Medication Adherence Scale
Time frame: At baseline, weekly for 4 weeks or till healing. (From enrollment to the end of treatment at 4 weeks)
Pain intensity will be measured using Visual analogue scale (VAS).
Time frame: At baseline, daily for the first week, then weekly for the remaining 3 weeks or till healing (From enrollment to the end of treatment at 4 weeks).
Clinical improvement will be measured using Thongprasom et al. scoring system.
Time frame: At baseline, and weekly for 4 weeks or till healing. (From enrollment to the end of treatment at 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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.
Yasmine Nasir El-Alami, Master's degree student contact
Shereen A Hassan, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard verbal instructions, Explanatory leaflets and text msgs in people with Degree of Adherence of Symptomatic OLP Patients to Their Medications, run by Cairo University 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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmine Nasir El-Alami, Master's degree student (00201080892469, yasmine.elalami@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of adherence [objective assessment] will be assessed by weighing tubes or counting pills. (time frame: from enrollment to the end of treatment at 4 weeks). 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 16 Oct 2026.