Effects Of Topical Clobetasol Versus Coconut Oil Cream In The Treatment Of Oral Lichen Planus

Detailed Description of the Clinical Trial

Study Title

Effects of Topical Clobetasol Versus Coconut Oil Cream in the Treatment of Oral Lichen Planus

1. What is the purpose of this study?

   The purpose of this clinical trial is to compare two topical treatments for oral lichen planus (OLP): clobetasol ointment and a specially prepared coconut oil cream.

   Oral lichen planus is a chronic inflammatory condition that affects the tissues inside the mouth. It can appear as white lines, patches, or other types of lesions. Some people may have no symptoms, while others may experience burning, pain, difficulty eating, or difficulty speaking.

   The main purpose of this study is to find out whether coconut oil cream can reduce the size of oral lichen planus lesions and the burning sensation experienced by patients, and to compare its effects with topical clobetasol.

   Clobetasol is a topical corticosteroid and is commonly used in the management of oral lichen planus. However, prolonged use of topical corticosteroids can be associated with adverse effects such as thinning of the oral lining, oral fungal infection (candidiasis), hypersensitivity reactions, and reduced compliance with treatment.

   Coconut oil has been considered as a possible alternative treatment because of its reported bactericidal, anti-inflammatory, and antioxidant properties. Previous studies cited in the study protocol have reported beneficial effects of coconut-containing preparations in oral lichen planus. This study will therefore evaluate coconut oil cream in comparison with clobetasol in the local patient population.

2. What is oral lichen planus?

   Oral lichen planus is a chronic inflammatory disorder affecting the oral mucosa. The condition is associated with immune-system mechanisms involving T cells and other inflammatory processes. The exact cause of oral lichen planus is not completely understood.

   OLP can occur in several clinical forms, including:

   * Reticular

   * Erosive

   • Plaque-like
   • Atrophic
   • Ulcerative
   • Bullous

   The appearance and severity of OLP can vary from person to person. Some patients may have lesions without significant symptoms, whereas others may have painful or irritated areas associated with burning, difficulty eating, or difficulty speaking.

   In the study protocol, oral lichen planus is clinically defined by the presence of white papules that may enlarge and join together to form a reticular, annular, or plaque-like pattern within the oral cavity.

3. Why is this study being conducted?

   The main goal of treatment for oral lichen planus is to reduce symptoms such as pain and burning, maintain good oral hygiene, and avoid factors that may make the condition worse.

   Several treatments have been used for OLP, including corticosteroids and other therapies. According to the study protocol, topical corticosteroids remain the main treatment approach.

   Clobetasol is one of the topical corticosteroids used for OLP. Although it can be useful, prolonged corticosteroid treatment can be associated with adverse effects. Therefore, researchers are interested in evaluating other possible topical treatment options.

   Coconut oil is being studied because it has properties that may potentially be useful in managing inflammation and irritation. The study protocol also refers to previous research that has reported comparable effects of some coconut-based preparations and corticosteroid treatments in reducing lesion size and pain.

   However, this study is being conducted to evaluate these treatments directly in the planned study population rather than assuming that one treatment is better than the other.

4. What are the main questions of the study?

The study is designed to compare the effects of topical clobetasol and coconut oil cream.

The main outcomes being assessed are:

1. Change in the size of the oral lichen planus lesion. 2. Change in the patient's burning sensation.

The size of the lesion will be assessed using photographs taken with a mobile camera. The photographs will be used to assess lesion size in square centimetres.

The patient's burning sensation will be assessed using a numeric pain-rating scale.

The study will compare the measurements before treatment with measurements obtained during and after treatment, with the final assessment taking place at the end of 14 weeks.

5. What type of study is this?

This is a single-blinded randomized controlled trial.

The study will be conducted in the Department of Oral and Maxillofacial Surgery at Abbasi Shaheed Hospital, Karachi.

A total of 116 patients are planned to participate. Participants will be divided into two groups, with 58 participants in each group.

Participants will be assigned to the treatment groups using a computer-generated random sequence. Allocation will be concealed using sealed opaque envelopes.

Random allocation means that participants are assigned to one of the two treatment groups by chance rather than by the participant or researcher choosing the treatment group.

6. Who can participate?

The study is intended for adults with clinically confirmed oral lichen planus.

Participants must:

• Be between 18 and 60 years of age.
• Be male or female.
• Have clinically confirmed oral lichen planus.

Certain people will not be eligible to participate. These include patients:

• With other potentially malignant disorders who are receiving treatment for those conditions.
• Who are pregnant.
• Who are breastfeeding.
• Who have received some form of treatment for oral lichen planus within the previous three months.
• Who have a known allergy to any of the study preparations.
• Who have uncontrolled systemic diseases, including diabetes mellitus, hypertension, autoimmune disorders, or hepatic or renal impairment.

These criteria are intended to define the study population and ensure that participants meet the conditions specified in the research protocol.

7. What will happen before treatment?

Before entering the study, eligible patients will be informed about the purpose of the research, the procedures involved, possible risks, and potential benefits.

Written informed consent will be obtained before participation.

The investigator will collect information including:

• Age
• Gender
• Duration of symptoms
• History of diabetes mellitus

An examination of the mouth will then be performed.

A photograph of the oral lesion will be taken using a mobile camera. The same camera will be used throughout the study for oral photographs.

The photographs will be used to assess the size of the lesion.

The patient's baseline burning sensation will also be recorded using a numeric pain-rating scale ranging from 0 to 5.

8. How will participants be assigned to treatment?

After the baseline assessment, participants will be randomly assigned to one of two groups.

Group 1: Coconut oil cream

Participants in this group will receive the specially prepared coconut oil cream.

Group 2: Clobetasol

Participants in this group will receive topical clobetasol propionate 0.05% ointment.

The treatment assignment will be determined through the computer-generated randomization process described in the study protocol.

Participants will not choose which treatment group they enter.

9. What is the coconut oil cream?

The coconut oil cream used in this study is not simply ordinary coconut oil applied directly to the mouth.

According to the study protocol, 100 grams of the study cream will be prepared using:

• Virgin coconut oil - 50 g
• Beeswax - 20 g
• Honey - 15 g
• Aloe vera gel - 10 g
• Vitamin E oil - 5 g

The cream will be prepared under supervision according to the procedure described in the protocol.

The beeswax will first be melted in a double boiler. Virgin coconut oil, honey, aloe vera gel, and vitamin E oil will then be gradually mixed into the melted beeswax with continuous stirring. The mixture will then be allowed to cool slightly without becoming completely solid.

The preparation will be carried out following the study's specified protocol and under the supervision of the study supervisor.

10. How will the treatments be applied?

Participants in both treatment groups will receive instructions on how to apply their assigned treatment.

For the coconut cream group, participants will first dry the affected oral mucosa using sterile gauze. A thin layer of the coconut oil cream will then be applied directly over the lesion using either a clean finger or a cotton applicator.

The coconut oil cream will be applied twice daily.

Participants will be instructed not to eat or drink for at least 30 minutes after application. This is intended to allow adequate contact between the treatment and the oral mucosa.

Participants in the clobetasol group will receive the same general application instructions and will apply clobetasol propionate 0.05% ointment twice daily.

Treatment will continue for 14 weeks.

11. What should participants do during treatment?

Participants will be asked to maintain good oral hygiene throughout the study.

They will also be advised to avoid spicy or irritating foods during the treatment period.

Participants should follow the treatment instructions provided by the study team and attend the scheduled follow-up visits so that their response to treatment can be monitored.

The study team will assess the lesion and symptoms regularly rather than relying only on the participant's final assessment at the end of the study.

12. How long will participation last?

The treatment period is 14 weeks.

Participants will have regular follow-up assessments during this period. The study protocol specifies follow-up at weeks 2, 4, 8, 12, and 14, while the data collection section describes regular visits every two weeks for recording lesion size and burning sensation.

The final assessment will be performed at the end of the 14th week.

13. What will happen during follow-up visits?

At follow-up visits, the study team will monitor the participant's oral lichen planus.

The researchers will record:

• The size of the oral lesion.
• The participant's burning sensation.
• Any adverse effects or other problems observed during treatment.

The lesion will be photographed using the designated mobile camera, and the photographs will be used to assess lesion size.

The participant's burning sensation will be recorded using the numeric pain-rating scale.

The study also includes monitoring for possible adverse effects, including oral irritation, hypersensitivity reactions, candidiasis, and worsening of the lesions.

14. How will burning or pain be measured?

Burning sensation will be assessed using a numeric rating scale from 0 to 5.

The scale records increasing severity of the patient's symptoms, with:

* 0 - No pain

* 1 - Slight pain

• 2 - Mild pain
• 3 - Severe pain
• 4 - Very severe pain
• 5 - Extremely severe pain

The score will be recorded at baseline and during subsequent follow-up visits.

This allows the researchers to compare changes in symptoms over the course of treatment.

15. How will the size of the lesion be measured?

The study will use photographs of the oral cavity to assess the size of the lesion.

A mobile camera will be used to photograph the affected area. The same camera will be used throughout the study.

The photographs will be assessed using Adobe Photoshop to determine the size of the lesion.

The protocol specifies that the post-treatment lesion size will be assessed at the end of 14 weeks and recorded in square centimetres.

Lesion measurements are also recorded at different study time points as part of the follow-up process.

16. What happens if the coconut cream does not work?

The study includes a predefined rescue treatment protocol.

Participants receiving coconut oil cream who show no clinical improvement or whose symptoms worsen within 2-4 weeks will be transitioned to standard treatment with topical clobetasol.

This means that participants in the coconut cream group will not be expected to continue an ineffective or worsening treatment indefinitely.

The study team will monitor participants closely and provide appropriate medical management if an adverse reaction occurs.

17. What are the possible risks?

As with any treatment, participants may experience unwanted effects.

The study specifically states that participants will be monitored for:

• Mucosal irritation
• Hypersensitivity reactions
• Candidiasis, which is an oral fungal infection
• Progression or worsening of the oral lesions

The study protocol also notes that prolonged use of corticosteroids such as clobetasol can be associated with epithelial atrophy, candidiasis, hypersensitivity reactions, and reduced patient compliance.

Participants will be monitored throughout the study for these potential problems.

18. What happens if a participant develops a side effect?

If a participant experiences an adverse reaction, the study intervention will be discontinued and appropriate medical management will be provided.

The study protocol states that patients will be closely monitored and that immediate management will be provided when adverse events occur.

The consent information also states that the cost of treatment for an adverse event will be borne by the principal investigator.

19. What are the possible benefits?

The study is designed to determine how the two treatments affect oral lichen planus.

A participant may experience a reduction in lesion size or burning sensation during treatment, but the study protocol does not guarantee that an individual participant will benefit.

The information obtained from the study may help researchers and healthcare professionals understand the potential role of coconut oil cream in the treatment of oral lichen planus.

The study is specifically intended to compare the effects of coconut oil cream and clobetasol rather than assuming in advance that one treatment will be more effective.

20. Is participation voluntary?

Yes.

Participation in the study is voluntary.

Before enrollment, the study purpose, procedures, risks, and benefits will be explained to the participant, and informed consent will be obtained.

Participants have the right to leave the study at any point.

The consent form also states that participants will not receive a monetary benefit for participating in the study.

21. What happens to participant information?

Information provided by participants will be treated as confidential.

The consent form states that participant information will not be used for another study without the participant's knowledge and prior consent.

The research team will collect information required for the study, including demographic and clinical information, lesion measurements, symptom scores, and information about adverse events.

22. Who will conduct the study?

The study is being conducted in the Department of Oral and Maxillofacial Surgery, Abbasi Shaheed Hospital/Karachi Medical and Dental College, Karachi.

The study was submitted by Dr Mir Imaduddin Wasif, F.C.P.S II resident in Oral Maxillofacial Surgery, under the supervision of Dr Sufyan Ahmed, Head of the Department of Oral and Maxillofacial Surgery.

The study protocol states that approval will be obtained from the research department of the College of Physicians and Surgeons Pakistan and the Ethical Review Committee of Karachi Medical and Dental College before the study begins. It also states that a clinical trial registration number will be obtained before initiation of the study.

23. How will the researchers make sure the comparison is fair?

The study uses random allocation.

Participants will be allocated to the two treatment groups using a computer-generated random sequence. Allocation concealment will be performed using sealed opaque envelopes.

The study is also described as single-blinded. In addition, the final outcome assessment will be performed by an independent blinded evaluator.

These methods are included in the protocol to reduce the influence of treatment allocation and assessment on the study results.

24. What information will researchers collect?

The study will collect information necessary to compare the two treatment groups.

This includes:

• Age
• Gender
• Duration of symptoms
• History of diabetes mellitus
• Location of the lesion
• Size of the lesion
• Burning sensation/pain score
• Changes in lesion size during treatment
• Changes in burning sensation during treatment
• Adverse events

The study proforma identifies several possible lesion locations, including the buccal mucosa, tongue, lips, gingiva, palate, and floor of the mouth.

25. What happens to the study results?

The researchers will compare the results from the coconut cream group with those from the clobetasol group.

They will assess whether there are differences between the groups in terms of:

• Lesion size after treatment.
• Burning sensation after treatment.

The statistical analysis will be performed using SPSS version 27.

The researchers will assess the distribution of numerical data and calculate appropriate measures such as mean and standard deviation or median and interquartile range.

Categorical information, such as gender and history of diabetes mellitus, will be presented using frequencies and percentages.

The study protocol states that a P value of 0.05 or less will be considered statistically significant.

26. What is the expected number of participants?

The planned sample size is 116 patients with oral lichen planus.

There will be:

• 58 participants in the coconut oil cream group
• 58 participants in the clobetasol group

The sample size was calculated using the OpenEpi calculator based on the lesion-size data described in the study protocol, with 80% statistical power and a 5% significance level.

27. How will patients be recruited?

Eligible patients will be recruited consecutively from the outpatient department of Oral and Maxillofacial Surgery at Abbasi Shaheed Hospital, Karachi.

The study will begin after the required research and ethical approvals have been obtained.

Potentially eligible patients will be assessed against the inclusion and exclusion criteria. Those who meet the criteria and agree to participate will provide informed consent before being enrolled.

28. What should participants know about the treatments?

The study is comparing two topical treatments.

One group will receive the specially prepared coconut oil cream, while the other group will receive clobetasol propionate 0.05% ointment.

Neither treatment should be considered guaranteed to work for every participant. The purpose of the clinical trial is to collect measurements in a structured way and determine how the two treatments perform in the study population.

Participants should follow the application instructions and attend their scheduled assessments so that their response and safety can be evaluated properly.

29. What should participants do if their symptoms become worse?

Participants should inform the study team if their symptoms worsen or if they develop an unusual reaction during treatment.

The protocol requires monitoring for worsening lesions, mucosal irritation, hypersensitivity reactions, and candidiasis.

For participants receiving coconut cream, lack of improvement or worsening within 2-4 weeks triggers the study's rescue protocol, under which the participant will be transitioned to topical clobetasol.

If an adverse reaction occurs, the study intervention will be discontinued and appropriate medical management will be provided.

30. What are the responsibilities of the healthcare team?

The healthcare team will:

• Assess whether a patient meets the eligibility criteria.
• Explain the study to potential participants.
• Obtain informed consent.
• Record relevant medical and clinical information.
• Examine the oral lesions.
• Photograph the lesions for assessment.
• Record burning sensation using the study pain scale.
• Randomly allocate eligible participants to a treatment group.
• Provide instructions on application of the assigned treatment.
• Monitor patients during follow-up.
• Record lesion size and burning sensation.
• Monitor for adverse events.
• Provide appropriate management if an adverse reaction occurs.
• Apply the rescue protocol when required.
• Conduct the final assessment at 14 weeks.

The protocol specifies that outcome assessment will be performed by an independent blinded evaluator.

31. What are the responsibilities of participants?

Participants are expected to:

• Provide accurate information about their medical history and symptoms.
• Use the assigned treatment according to the instructions.
• Apply the treatment twice daily.
• Avoid eating or drinking for at least 30 minutes after application.
• Maintain oral hygiene.
• Avoid spicy or irritating foods during treatment.
• Attend scheduled follow-up visits.
• Inform the healthcare team about adverse effects or worsening symptoms.
• Cooperate with lesion photography and symptom assessment.

Following these procedures helps the researchers collect complete and consistent information throughout the study.

32. Why are regular follow-ups important?

Regular follow-up is an important part of the study because oral lichen planus symptoms and lesions can change during treatment.

By assessing participants at multiple time points, researchers can document changes in lesion size and burning sensation rather than measuring only the beginning and end of treatment.

Regular visits also allow the study team to identify adverse effects or worsening disease and provide appropriate management when necessary.

The protocol specifies follow-up assessments throughout the treatment period, with a final assessment at week 14.

33. What happens at the end of the study?

At the end of the 14-week treatment period, participants will undergo a final assessment.

The researchers will assess:

* The final size of the oral lichen planus lesion.

• The final burning sensation score.
• Any adverse effects experienced during the study.

The final measurements will be compared with the baseline measurements and with the results from the other treatment group.

The purpose is to determine whether the two treatment approaches produced different outcomes in the study population.

34. What does this study not promise?

Participation in this study does not guarantee that oral lichen planus will disappear or that symptoms will improve.

The purpose of the study is to evaluate and compare two treatments.

The researchers cannot guarantee that an individual participant will experience a particular outcome.

Similarly, the study is not designed to establish that coconut oil cream is better than clobetasol before the results are collected. The comparison is being performed to obtain evidence regarding lesion size, burning sensation, and safety.

35. Important information for patients and families

Patients and families should understand that oral lichen planus can vary considerably between individuals. Some people may have lesions without significant symptoms, while others may experience burning, pain, difficulty eating, or difficulty speaking.

The study is designed to monitor these symptoms systematically.

Participation involves regular treatment and follow-up for 14 weeks. Participants will need to apply their assigned treatment twice each day and attend the required follow-up assessments.

Patients should communicate openly with the healthcare team about any change in symptoms, irritation, allergic reaction, oral fungal infection, or worsening of the lesions.

The study includes a rescue-treatment plan for participants in the coconut cream group who do not improve or who worsen during the first 2-4 weeks.

36. Important information for healthcare providers

Healthcare providers involved in the study should follow the study protocol consistently.

Eligible patients should be identified according to the stated inclusion and exclusion criteria. Informed consent must be obtained before participation.

Treatment allocation should follow the computer-generated randomization procedure and allocation concealment process.

The prescribed treatment should be applied according to the study protocol:

• Coconut oil cream: twice daily.
• Clobetasol propionate 0.05% ointment: twice daily.
• Treatment duration: 14 weeks.

Participants should be monitored at the specified follow-up points.

The healthcare team should document lesion size, burning sensation, and adverse events. Any adverse reaction should be managed appropriately, and the study intervention should be discontinued when required.

For participants receiving coconut cream who fail to improve or worsen within 2-4 weeks, the protocol specifies transition to topical clobetasol as rescue therapy.

37. Confidentiality and informed consent

Before entering the study, participants will receive information about the purpose of the study, the procedures, risks, and benefits.

Written informed consent will be obtained.

The consent documentation includes participant, investigator, and witness signatures.

The study consent form states that information provided by participants will be kept confidential and will not be used for another study without their knowledge and prior consent.

Participation is voluntary, and participants have the right to withdraw from the study at any time.

38. Summary

This clinical trial is designed to compare topical coconut oil cream with topical clobetasol 0.05% ointment in adults with oral lichen planus.

A total of 116 participants are planned, with 58 participants in each treatment group. Participants will be randomly assigned to one of the two groups.

Both treatments will be applied twice daily for 14 weeks. Participants will attend regular follow-up visits during the study.

Researchers will mainly evaluate:

• The size of the oral lichen planus lesion
• The patient's burning sensation

Participants will also be monitored for possible adverse effects, including oral irritation, hypersensitivity, candidiasis, and worsening of the lesions.

If a participant in the coconut cream group does not improve or becomes worse within 2-4 weeks, the study's rescue protocol allows transition to topical clobetasol.

The study is intended to provide a structured comparison of these two topical treatments and to determine their effects on oral lichen planus within the study population.

Participation is voluntary. Participants will provide informed consent, their information will be kept confidential, and they may withdraw from the study at any time.