Is Tacrolimus or Steroid the final answer?

As I have mentioned, the treatment of exfoliative cheilitis is not easy. There is still no clear research on its aetiology. Regarding to usual biopsy results of exfoliative cheilitis sufferers, they will find non-specific inflammation. Some medical practitioners have advocated the use of anti-inflammatory drugs such as topical glucocorticoids (steroids) to treat EC. Another relatively new drug called Tacrolimus, has been used with some success for managment of exfoliative cheilitis.

Tacrolimus is also an anti-inflammatory medication. It is a macrolide immunosuppressant.

There is a randomized controlled study trying to compare the clincial efficacy of using topical 0.03% Tacrolimus vs 0.1% triamcinolone acetonide cream (a topical steroid cream) for patients with EC. Recruited EC patients were randomly assigned to receive either topical Tacrolimus or topical steroid. And then asked to follow a protocol of first cleaning the scaling or crust on the lips with 0.12% chlorhexidine (a usual antiseptic solution) followed by applying a thin layer of 0.03% Tacrolimus or 0.1% triamcinolone dependant on the randomization, also asked to not eat or drink for an hour after the medication application, together with wearing a mask for UV defence. Petroleum jelly was also used to keep the lips moist.

They did the medication application at 3, 2, and 1 daily doses for 1 course, in the first, second, and third weeks. After 3 weeks of tacrolimus treatment, blood was taken to assess blood tacrolimus level.

In that study, 40 patients with EC were recruited and eligible to receive the medication after screening for other medical conditions. After 3 weeks, 18 patients showed complete healing of scaling lesions 72%, so receiving the 0.03% Tacrolimus show satistically significant improvent regarding the scaling compared to the control group (receiving steroid cream). Also, reduction in roughness and pruritis were seen more significantly compared to the control group.

However, at 3 month follow up time, 17 patients with complete healing attended the follow up, with 4 patients from Tacrolimus group and all 4 patinets from control (steroid cram) group showing relapse. For the blood Tacrolimus concentration, all undergo blood test showed normal Tacrolimus concentration.

So, this study showed Tacrolimus may be useful in the treatment of exfoliative cheilitis. One of the cons of Tacrolimus being its risk of increased odds of having cancer and adverse reactions ranging from renal toxicity to cardiovascular problems. The merit of this study is showing after 3 weeks use of Tacrolimus topically will be safe. The average level was only 0.87 ng/ml after 3 week treatment. Generally speaking, a level of lower than 5 ng/ml should be viewed as safe.


LIU, Junjiang, et al. Tacrolimus 0.03% ointment treatment in exfoliative cheilitis: A randomised controlled clinical trial and monitoring blood concentration. Journal of Oral Pathology & Medicine, 2021, 50.2: 251-259.

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