0.1% Tacrolimus Ointment for the Treatment of Intertrigo

Intertrigo is a combination of infectious, mechanical, and inflammatory changes of the skin folds that can be recurrent and chronic. Friction between skin folds and increased moisture promote an irritated cutaneous environment that increases the chance of infection. The combination of these factors leads to an inflammatory process.

Historically, medium- to mild-potency topical steroids were prescribed for quick resolution of these inflammatory changes, but continued long-term therapy is sometimes required. This is not optimal because of atrophy and striae formation, especially in the intertriginous areas, associated with long-term topical steroid use. Thus, we used a nonsteroidal topical ointment, 0.1% tacrolimus, for 6 weeks in 10 patients with intertrigo.

Ten patients provided informed consent and were enrolled via screening in a hospital-based academic dermatology clinic. 0.1% Tacrolimus ointment was applied twice daily to the affected area for 6 weeks. Patients were excluded if infection was present.

Evaluation via physician’s global assessment, patient’s global assessment, and erythema scores was recorded at 1, 3, and 6 weeks and ranked as clear, 75% clear, 50% clear, 25% clear, or no change compared with baseline. Adverse effects were recorded. If completely clear, the patient was allowed to decrease frequency to daily application.

Nine of 10 patients completed the study. Six men and 4 women were enrolled. Four patients had intertrigo of the inframammary area, and 2 each had intertrigo of the abdomen, groin, and axillae. The 1 patient who withdrew from the study complained of intolerable burning and discomfort after 2 days of application.

Ten sites of intertrigo were treated in 9 patients who completed the study. Seven (78%) of 9 patients were clear or 75% clear at week 1 by both the physician’s and patient’s global assessment. At 6 weeks, 8 (88%) of 9 were clear.

The most common adverse effect was burning at application site. Most patients reported burning at week 1, but this was decreased at week 3. Pruritus was the second most common adverse effect. No infections developed during the treatment period.

While intertrigo is not difficult to diagnose, it can be difficult to treat and cure. Moisture can be reduced, infections can be treated with antibiotics, and topical steroids will relieve the inflammatory changes; however, adverse effects limit their use.

The main advantage of 0.1% tacrolimus ointment is that it is not a steroid. It is a T-cell immunosuppressant that acts via inhibition of intranuclear phosphatase calcineurin. It is currently approved by the Food and Drug Administration for the treatment of atopic dermatitis,¹ but it has been shown to be effective for various other inflammatory skin conditions, including seborrheic dermatitis² and inverse psoriasis.³

In this small study, 0.1% tacrolimus ointment proved to be rapidly effective, as most patients were clear or 75% clear after 1 week of twice daily application. Only 1 of 9 patients failed to clear after 6 weeks of treatment. Burning at the application site was the most common adverse effect, but it was usually transient and tolerable. Tacrolimus seems to be a safe, effective treatment for intertrigo and avoids the potential adverse effects of topical steroids.

Correspondence: Dr Chapman, Section of Dermatology, 1 Medical Center Dr, Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756 (M.Shane.Chapman@Hitchcock.org).

Financial Disclosure: Dr Chapman is a consultant and has performed clinical trials for Fujisawa Healthcare Inc. Mr Linowski is a scientific affairs manager for Fujisawa Healthcare Inc.

Funding/Support: This study was designed by Dr Chapman and supported by a grant from Fujisawa Healthcare Inc.