Occlusive Treatment Enhances Efficacy of Tacrolimus 0.1% Ointment in Adult Patients with Vitiligo: Results of a Placebo-controlled 12-month Prospective Study

Abstract

Topical tacrolimus was recently introduced as a novel therapeutic option in vitiligo. Excellent results were seen mainly on the face and neck areas. We treated 30 adult vitiligo patients with tacrolimus 0.1% ointment twice daily, and compared the results with those of placebo ointment. In 20 patients, defined areas on the right arm or leg were occluded overnight with 3 different dressings. Repigmentation was evaluated quantitatively and qualitatively. Quality of life changes were assessed with the Dermatology Life Quality Index. After 6 months, treatment was stopped in 7 of 30 patients as they did not show any repigmentation, 5 of them had no occlusive therapy. After 12 months, 17 of 21 patients (81%) with facial involvement showed repigmentation of the face. Although no or minimal repigmentation occurred on the extremities when using tacrolimus ointment alone, 80% of the patients showed repigmentation on the arms when using additional occlusive, especially hydrocolloid dressings. Hands, feet and lower legs were unresponsive. The best results were obtained in patients with long-standing vitiligo. Only minimal side-effects were noted. There was no significant elevation in tacrolimus blood levels, taking into account that occlusion was performed only on limited parts of the body. In conclusion, tacrolimus 0.1% ointment proved an effective and safe treatment option for adult patients with vitiligo. Beyond the face and neck areas, repigmentation could be achieved only by additional occlusion.

A prospective study comparing the safety and efficacy of combination of topical tacrolimus 0.1% and mometasone furoate 0.01% with topical tacrolimus 0.1% alone in vitiligo

“…The response rates vary between 63% and 89% depending on the type and location of vitiligo, with good results for face and neck lesions. [8][9][10] Topical Tacrolimus alone has been proven to be effective in treatment of vitiligo in different age groups in different studies conducted in different parts of the world. Even in patients with generalized vitiligo it has found to be effective in combination with NBUVB therapy.…”

Treatment of Generalised Vitiligo with Tacrolimus 0.1% Ointment vs. UVB Intense Pulsed Light Phototherapy: A Pilot Study

“…Our pilot study in 11 patients, although small, clearly indicated that intra-individual differences occur and that treatment response to one of the topical approaches does not generally imply response to another treatment as well. Although it is known that tacrolimus -in contrast to corticosteroids -does not penetrate through an intact skin barrier and into the circulation, the possibility and relevance of systemic effects of either of the 2 topical treatment approaches cannot be completely excluded (6,12). Importantly, for the individual patient, response to either of the 2 treatments is currently not predictable and may vary considerably between different body areas.…”

“…Targeted phototherapy was performed once weekly on the respective lesions of the left side, using a BBUVB light source with peak emission at 311 nm (RelumeMode, Lumenis). Treatment of hands and feet was spared, as these regions are known to be treatment resistant (3,(5)(6)(7).…”

“…Given twice weekly up to every second week for less than 60 sessions they allow both the reduction of number of treatments as well as the cumulative doses along with higher efficiency. Furthermore, calcineurin antagonists like tacrolimus and pimecrolimus were introduced as topical immunomodulators for vitiligo and proved to be equally effective as clobetasol (5)(6)(7)(8). Using overnight occlusive hydrocolloid dressings they proved to be effective and safe also in poorly repigmenting body areas like forearms and shins (4,5).…”

Topical Calcineurin Inhibitors in the Treatment of Vitiligo

“…al. 50 used polyurethane foil or hydrocolloid dressings for overnight occlusive treatment, and moderate to excellent repigmentation was achieved, depending on the dressing utilized. It was suggested that since hydrocolloid dressings lead to higher stratum corneum water holding capacity compared with polyurethane foil 51 , the hydrocolloid dressings may be more suitable for enhancing the transcutaneous penetration of the topically applied agent.…”