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

Background and rationale Oral lichen planus (OLP) is a chronic inflammatory disease of the oral mucosa. It is driven by a T-cell-mediated immune response in which cytotoxic T cells are activated against the oral epithelium, together with non-specific mechanisms such as mast cell degranulation and matrix metalloproteinase activation. Its presentation ranges from asymptomatic white lesions to painful erosions that cause burning, difficulty eating and impaired speech. Management aims to relieve pain and burning, maintain oral hygiene and remove local aggravating factors. Topical corticosteroids such as clobetasol are the mainstay of treatment, but prolonged use is associated with epithelial atrophy, oral candidiasis, hypersensitivity reactions and reduced patient compliance.

These limitations have increased interest in herbal and natural alternatives. Coconut oil has reported antibacterial, anti-inflammatory and antioxidant properties. Earlier trials of coconut-based preparations found efficacy comparable to corticosteroids for lesion size and pain, and a more recent trial of a coconut-containing herbal cream reported superior pain reduction. Evidence from the local population is lacking, and this trial was designed to fill that gap.

Trial design This is a single-blinded, parallel-group randomized controlled trial conducted in the Department of Oral and Maxillofacial Surgery, Abbasi Shaheed Hospital, Karachi. Patients are enrolled consecutively and allocated 1:1 to coconut oil cream or clobetasol 0.05% ointment. The allocation sequence is computer-generated, and concealment uses sealed opaque envelopes opened only after enrolment. Because patients can see which preparation they receive, blinding applies to outcome assessment, which is done by an independent evaluator who does not know the allocation.

The planned sample is 116 participants (58 per group). It was calculated with the OpenEpi calculator at 80% power and a 5% significance level, using lesion size change from baseline to week 14 reported in a previously published comparison of coconut cream and clobetasol.

Preparation of the coconut oil cream The cream is prepared in-house under supervisor oversight following a standard protocol. For each 100 g batch, the ingredients are virgin coconut oil (50 g), beeswax (20 g), honey (15 g), aloe vera gel (10 g) and vitamin E oil (5 g). The beeswax is melted in a double boiler. The other ingredients are then added gradually with constant stirring to ensure even mixing. The mixture is cooled slightly but not allowed to solidify completely before use.

Study procedures At enrolment, the principal investigator takes a history (age, gender, duration of symptoms, history of diabetes mellitus) and performs an oral examination. The lesion is photographed with a mobile camera, and the same camera is used at every visit to keep image capture consistent. Lesion area is measured from the photographs with Adobe Photoshop. Baseline burning sensation is recorded on the Numeric Pain Rating Scale. All data are entered in a standardized proforma.

Both groups follow the same application routine for 14 weeks. Participants dry the affected mucosa with sterile gauze, then apply a thin layer of the assigned preparation over the lesion twice daily with a clean finger or cotton applicator. They are asked not to eat or drink for at least 30 minutes afterwards so the preparation stays in contact with the mucosa. They are also advised to maintain oral hygiene and avoid spicy or irritant foods. Participants return to the clinic regularly, and lesion size and burning sensation are recorded at follow-up visits, with the final assessment at week 14.

Rescue treatment Participants in the coconut cream group who show no clinical improvement, or whose symptoms worsen, within 2 to 4 weeks are transitioned to topical clobetasol under a predefined rescue protocol. This protects participants from prolonged ineffective treatment.

Safety monitoring All participants are monitored throughout treatment for mucosal irritation, candidiasis, hypersensitivity reactions and progression of lesions. If an adverse reaction occurs, the study preparation is stopped and appropriate medical management is started. Treatment costs related to adverse events are borne by the principal investigator.

Statistical analysis Data are analysed in SPSS version 27. Normality is checked with the Kolmogorov-Smirnov test. Continuous variables are summarized as mean and standard deviation, or median and interquartile range if not normally distributed. Categorical variables are summarized as frequencies and percentages. The two groups are compared with the independent t-test. Potential effect modifiers (age, gender, symptom duration and diabetes) are handled by stratification, followed by post-stratification independent t-test or Mann-Whitney U test as appropriate. A p-value of 0.05 or less is considered statistically significant.

Approvals and registration The study is approved from college of physician and surgeon and ethical review board kmu.