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
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