Tacrolimus ointment helps restore pigment in facial vitiligo

Applying topical tacrolimus 0.1% twice daily for 6 months proves effective in the treatment of adult patients with facial vitiligo, as shown in a study.

As much as 65 percent of tacrolimus-treated patients achieved ≥75-percent repigmentation of the target lesion at week 24, as compared with 0 percent of vehicle-treated patients (p<0.0001), according to the investigators. More importantly, successful repigmentation with the study drug occurred rapidly—within just 12 weeks in 50 percent of the patients (p=0.0001). [J Invest Dermatol 2021;doi:10.1016/j.jid.2020.12.028]

“This study was specifically designed for patients with facial vitiligo because the head and neck are known to respond better to topical calcineurin inhibitors. Besides, these body locations are easily exposed to natural UV-light,” they pointed out.

All 42 patients enrolled in the trial were advised to expose themselves progressively to natural light throughout the treatment period, beginning with 5 to 10 minutes of sun exposure without sunscreen. In the absence of a light pink colour, exposure time had to be increased by 10 percent the next day. The maximum recommended sun exposure was 45 minutes per day.

“The importance of combined natural UV-light therapy with topical calcineurin inhibitors has been highlighted by previous studies. Indeed, this combined therapy, through melanocyte regeneration and immunomodulatory effects, seems critical in achieving successful repigmentation in facial vitiligo,” the investigators noted. [JAMA Dermatol 2019;155:929-938]

“In addition, natural sunlight exposure is a cost- and time-effective concomitant therapeutic option for patients with facial vitiligo. Experts have reported agreement with the low-risk nature of this combined treatment,” they continued. [Br J Dermatol 2013;168:5-19]

In the trial, 20 patients received tacrolimus 0.1% ointment, while 22 were given the vehicle treatment. All of them had recent facial vitiligo target lesions (<2 years) without changes in pigmentation or size over the previous 3 months.

At week 24, the mean depigmented area of the target lesion decreased from 21.9 to 5.5 cm² in the tacrolimus group (p=0.0003), while the size remained stable in the vehicle group (p=0.65). Overall, repigmentation occurred in 82.9 percent and 0.7 percent of patients in the respective groups.

Patients’ satisfaction scores and the physicians’ global assessment scores were markedly higher with tacrolimus versus the vehicle (p=0.03 and p<0.0001, respectively). However, scores on the Dermatology Quality of Life Index (DLQI) and Vitiligo Impact Patient (VIP) scale did not significantly differ between the two groups.

“Indeed, although patients achieved successful repigmentation of facial lesions, most still exhibited other visible vitiligo lesions that continued to impact their quality of life,” the investigators explained.

They also highlighted the potential role of maintenance intermittent treatment, as 10 patients on tacrolimus exhibited loss of pigment in >25-percent of the repigmented area during the 24-week post-treatment follow-up phase. “We presume that tacrolimus may limit tissue-resident memory T-cell activation, thus preventing vitiligo relapses. Markers linked to long-term response to tacrolimus topical treatment have not yet been assessed, but we propose that they include short disease duration, lower tissue-resident memory T-cell perilesional skin infiltration, and higher repigmentation rate at week 24.”

Side effects were minimal and consistent with more than 20 years of data regarding overall tacrolimus treatment. The most common side effects were mild and included transient erythema, as well as stinging and burning sensations that did not require treatment suspension.

Finally, the investigators acknowledged the limited generalizability of the findings, saying “our cohort may not have represented a wide array of ethnicities because this study was performed in a single country and no ethnicity data are available for the overall French population.”