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Not yet recruitingNCT07879300Updated Oct 16, 2026

Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial

An interventional study of standard verbal instructions and Explanatory leaflets in Degree of Adherence of Symptomatic OLP Patients to Their Medications, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Degree of Adherence of Symptomatic OLP Patients to Their Medications
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Intervention 1: Explanatory leaflet + Standard instructions

    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

    Behavioral: standard verbal instructions · Behavioral: Explanatory leaflets

  • Experimental
    Intervention 2 : Daily text message reminder + Standard instructions

    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.

    Behavioral: standard verbal instructions · Behavioral: text msgs

  • Active comparator
    Comparison [C]: Standard instructions

    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.

    Behavioral: standard verbal instructions

Interventions

  • Behavioralstandard verbal instructions

    this will be applied to all three groups

  • BehavioralExplanatory leaflets

    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

  • Behavioraltext msgs

    daily text message reminder to apply the medicine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: from enrollment to the end of treatment at 4 weeks

Secondary outcomes

  1. 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.

    Time frame: At baseline, weekly for 4 weeks or till healing. (From enrollment to the end of treatment at 4 weeks)

  2. 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.

    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).

  3. 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.

    Time frame: At baseline, and weekly for 4 weeks or till healing. (From enrollment to the end of treatment at 4 weeks)

Other outcomes

  1. Recurrence rate

    Number of attacks

    Time frame: At week 8 and week 12

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jun 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2026
First posted
Oct 16, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Oct 15, 2027
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07879300
Lead sponsor
Cairo University
Responsible party
Yasmine El Alami (Master degree student; Department of Oral Medicine and Periodontology; Faculty of Dentistry - Cairo University, Cairo University) — Principal investigator
First posted
Oct 16, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Oct 15, 2027 (estimated)
Last update
Oct 16, 2026

Study contacts

Yasmine Nasir El-Alami, Master's degree student
Contact
yasmine.elalami@dentistry.cu.edu.eg
00201080892469
Shereen A Hassan, PhD
study chair · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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