Smith D.A.et al.2828 Smith DA, Tofte SJ, Hanifin JM. Repigmentation of vitiligo with topical tacrolimus. Dermatology. 2002;205:301-3., 2002 Case report |
1 (M) 45 years old |
Face and scalp |
Topical tacrolimus ointment twice daily 18 months |
|
After 2 months of treatment, areas of repigmentation were noted in the patches of vitiligo on his face and scalp. Progressive improvement was noted at each subsequent follow-up visit, with over 90% repigmentation of these areas after 18 months of therapy. |
Grimes P.E et al.77 Grimes PE, Soriano T, Dytoc MT. Topical tacrolimus for repigmentation of vitiligo. J J Am Acad Dermatol. 2002;47:789-91., 2002 Non-controlled, non-blinded series |
6 (2 F, 4 M) Mean age 16 (range 7-38) |
All patients had generalized vitiligo affecting less than 20% of the cutaneous surface. |
4 patients (<16years old) were treated with 0.03% tacrolimus ointment and 2 patients (>16 y.o.) were treated with 0.1% tacrolimus ointment. The medication was applied to all the lesions twice daily. 1-5 months |
In general, side effects were mild in all patients. Burning and stinging sensations occurred at the treated sites, which resolved after 1 to 2 weeks. One of our patients developed localized tinea corporis in an area adjacent to vitiligo patches treated with tacrolimus ointment. |
Repigmentation of vitiligo lesions was graded as none, minimal (1%-25%), mild (25%-50%), moderate (50%-75%), and excellent (75%-100%). 4 patients treated with tacrolimus 0.03% ointment: 3 moderate and 1 mild. 2 patients treated with tacrolimus 0.1%: excellent and moderate. |
Lepe V.et al.1818 Lepe V, Moncada B, Castanedo-Cazares JP, Torres-Alvarez MB, Ortiz CA, Torres-Rubalcava AB. A double-blind randomized trial of 0.1% tacrolimus vs 0.05% clobetasol for the treatment of childhood vitiligo. Arch Dermatol. 2003;139:581-5., 2003 Double-blind randomized trial |
20 (16F,4M) Mean age 9.5 (range 4-17) |
Hands, Face, Legs, Elbows, Abdomen, Thorax, Axillae |
0.1% tacrolimus ointment,twice a day 2 months |
Burning sensation (2 patients) |
Repigmentation was 41.3% 5 patients: 75% repigmentation 2 patients: no change of pigmentation. |
Travis L.B.et al.2929 Travis LB, Weinberg JM, Silverberg NB. Successful treatment of vitiligo with 0.1% tacrolimus ointment. Arch Dermatol. 2003;139:571-4., 2003 Case series |
1(F, 23 years old) 1(M, 24 years old) 1(M, 10 years old) |
Affecting 75% of her face, including complete depigmentation of the eyelids, chin, cheeks, and perioral skin. depigmentation of 60% of his body surface area, including the eyelids, chin, axillae, elbows, hips, knees, and back. Depigmentation of the forehead, forearms, chest, back, and calves. |
0.1% tacrolimus ointment twice daily 0.1% tacrolimus ointment twice daily 0.1% tacrolimus ointment twice daily |
|
Complete repigmentation in 4 months. Completely repigmented after 2 months Complete repigmentation after 2 months. |
Tanghetti E.A.et al.3030 Tanghetti EA. Tacrolimus ointment 0.1% produces repigmentation in patients with vitiligo: results of a prospective patient series. Cutis. 2003;71:158-62. ,2003 prospective patient series |
15 (5M,10F) Mean age 32 years (4-61) |
Face, neck, forehead,left knee,ankle,hands,elbows,chest |
Tacrolimus ointment 0.1% 9 months |
|
13 patients (87%) experienced at least partial improvement with tacrolimus ointment 0.1%: 3 had greater than 75% repigmentation, 1 had 50% to 75% repigmentation, and 9 had greater than 0% to 25% repig-mentation. Two of the patients had no response to treatment. |
Kanwar A.J.et al.88 Kanwar AJ, Dogra S, Parsad D. Topical tacrolimus for treatment of childhood vitiligo in Asians. Clin Exp Dermatol. 2004;29:589-92.,2004 Open-label prospective |
22 children (9 boys and 13 girls) Mean age 7.2 |
|
topical 0.03% tacrolimus ointment applied twice daily 12 weeks (3 months |
Side effects were minimal, including pruritus and burning, noted in only three patients. |
Response was noted as marked to complete (> 75% repigmentation), moderate (50–75% repigmentation) and mild (< 50% repigmentation). Nineteen (86.4%) children showed some repigmentation at the end of 3 months and another three had no response. Of these 19 children, repigmentation was marked to complete in 11 (57.9%), moderate in five (26.3%) and mild in three (15.7%) children. |
Grimes P.E.et al.1919 Grimes PE, Morris R, Avaniss-Aghajani E, Soriano T, Meraz M, Metzger A. Topical tacrolimus therapy for vitiligo: therapeutic responses and skin messenger RNA expression of proinflammatory cytokines. J Am Acad Dermatol. 2004;51:52-61.,2004 Open-label prospective |
19 (8M,11F) Mean age 39 At least 15 years old |
Anatomic sites included face, neck, trunk, upper extremities, and lower extremities. |
All patients applied tacrolimus 0.1% ointment twice daily for 24 weeks. |
Signs and symptoms of irritation were minimal. |
At 24 weeks, 17 of 19 patients (89%) achieved varying levels of repigmentation. |
Silverberg N.B.et al.99 Silverberg NB, Lin P, Travis L, Farley-Li J, Mancini AJ, Wagner AM, et al. Tacrolimus ointment promotes repigmentation of vitiligo in children: a review of 57 cases. J Am Acad Dermatol. 2004;51:760-6.,2004 Review of cases |
57 (32F,25M) Mean age 9.2 (range 4-16) |
|
Patients were treated with tacrolimus 0.03% or 0.1% ointment for at least 3 months. 26 children were treated with the 0.03% ointment and 31 with the 0.1% ointment |
Burning |
Overall, 84% of the children responded at least partially to therapy. Of the 48 children placed on twice daily application regimens, 41 responded (85%). In contrast, only 55% of the 9 patients who used the medication once daily responded. |
Prats Caelles I.et al.3131 Prats Caelles I, Herranz Pinto P, de Ayala Casado EL, de Lucas Laguna R. Focal hypertrichosis during topical tacrolimus therapy for childhood vitiligo. Pediatr Dermatol. 2005;22:86-7.,2005 Case report |
1 (F) 8 years old |
Symmetrically involving the extensor surfaces of her arms, thighs, and knees. |
Tacrolimus 0.1% ointment Two months |
Two months after starting therapy and without previous injuries, the patient noticed hair growth over her right knee (focal hypertrichosis). |
Slow but evident focal repigmentation in all locations . Areas of vitiligo showed frank repigmentation with no other secondary findings. |
Almeida P.et al.2424 Almeida P, Borrego L, Rodríguez-López J, Luján D, Cameselle D, Hernández B. Vitiligo. Treatment of 12 cases with topical tacrolimus. Actas Dermosifiliogr. 2005;96:159-63., 2005 Open-label prospective |
12 (9M , 3F) Mean age 22 (range 4-66) |
Face, hands, arms, legs, foot, trunk, genitals. |
Topical tacrolimus 0.1 % twice a day |
Pruritus in the eyelid area in two patients during the first week of treatment (2 patients). |
50 % of the patients treated showed repigmentation with good (50 %-75 %) or excellent (> 75 %) improvement after 6 months |
Bakos L.et al.1414 Bakos L, Bakos RM. Focal acne during topical tacrolimus therapy for vitiligo. Arch Dermatol. 2007;143:1223-4., 2007 Case report |
1 (F) 18 years old |
Left side of her chin and neck and on both sides of the dorsum |
Topical 0.1% tacrolimus once daily 3 months |
At the end of 3 months, the cervical and chin spots showed an extensive eruption of inflammatory and noninflammatory lesions of acne, with papules, pustules, and closed comedones. |
Repigmentation of nearly 90% of the chin and cervical lesions and 50% of the dorsal spots. |
Hartmann A. et al.2020 Hartmann A, Bröcker EB, Hamm H. Occlusive treatment enhances efficacy of tacrolimus 0.1% ointment in adult patients with vitiligo: results of a placebo-controlled 12-month prospective study. Acta Derm Venereol. 2008;88:474-9.,2008 Prospective placebo controlled right-left comparison study |
30 (23F,7M) Mean age 43.7 (Range 19–65) |
Depigmented lesions of the face and neck (21 out of 31 patients) as well as of the right upper and lower extremity (31 patients). In 20 patients with widespread depigmentation on the right arm and leg, tacrolimus ointment was combined with overnight occlusive dressings in previously defined areas. |
Tacrolimus 0.1% ointment twice daily 12 months (3 months) |
Side-effects were documented in 80% of the patients. Transient facial flushing (n = 16), enhanced heat intolerance (n = 9), especially when drinking alcohol, burning (n = 4), mild pruritus (n = 2), and mild perioral folliculitis (n = 2). |
After 6 months, 23 of 30 patients (77%) was used as occlusive dressing (mean repigmentation 50%). After 12 months, 17 out of 21 patients (81%) with vitiligo lesions on the face showed repigmentation. Overall repigmentation was 60.5 % in the responding patients. |
Lotti et al.1313 Lotti T, Buggiani G, Troiano M, Assad GB, Delescluse J, De Giorgi V, et al. Targeted and combination treatments for vitiligo. Comparative evaluation of different current modalities in 458 subjects. Dermatol Ther. 2008;21:S20-6., 2008 Open-label study |
22 (range 18–72) |
|
Tacrolimus 0.1% twice daily 6 months |
|
Percentage of repigmentation: Excellent (> 75%) 61% Marked (50–75%) 16.1% Moderate (25–50%) 18.4% Minimal (< 25%) 4.5% |
De. D. et al.1010 De D, Kanwar AJ. Tacrolimus-induced hyperpigmentation in a patch of vitiligo. Skinmed. 2008;7:93-4., 2008 Case report |
1 (M) 10 years old |
Infraorbital area, arms, thighs, and around the knees and ankles |
Tacrolimus ointment 0.03% 2 months |
Brownish hyperpigmentation in the previous patch of vitiligo in infraorbital area (hyperpigmentation). |
After 2 months of therapy, all the lesions repigmented completely with excellent color matching except those in the infraorbital area. |
Choi C.W.3232 Choi CW, Chang SE, Bak H, Choi JH, Park HS, Huh CH, et al. Topical immunomodulators are effective for treatment of vitiligo. J Dermatol. 2008;35:503-7., 2008 Retrospective review |
51 |
Face, hand, foot |
Tacrolimus ointment 0.1% 6 months |
|
>60% responders |
Xu A.E.2121 Xu AE, Zhang DM, Wei XD, Huang B, Lu LJ. Efficacy and safety of tarcrolimus cream 0.1% in the treatment of vitiligo. Int J Dermatol. 2009;48:86-90., 2009 Prospective study |
30 (9M, 21F) Mean age 22.3 (range 7–40) |
In all, 40 target lesions were treated. Among them, 10 lesions were on the cheek, 7 lesions were on the forehead, 2 lesions were on the eyebrow, 5 lesions were on the eyelid, 3 lesions were on the prenarse, 3 lesions were perioral, 5 lesions were on the neck, 4 lesions were on the trunk, and 1 lesion was on the back of the hand. |
0.1% tacrolimus ointment twice a day 4 months |
Burning (4 patients) |
Twenty-five (83.3%) patients showed some repigmentation at the end of 4 months and the other five patents had no response. |
Z.A. Taher Z.A. et al.3333 Taher ZA, Lauzon G, Maguiness S, Dytoc MT. Analysis of interleukin-10 levels in lesions of vitiligo following treatment with topical tacrolimus. Br J Dermatol. 2009;161:654-9., 2009 Open-label prospective |
20 (10 M, 10 F) Mean age 40.45 All above the age of 18 years |
Right thigh,Left thigh, Left arm, Right cheek,Right axilla, Left neck, Right thigh, Right abdomen, right postauricular,Left axilla,Left flank, Left forearm, Left chest, Right hip, Posterior neck. |
Tacrolimus (0.1%) ointment, twice daily 3 months |
|
Qualitatively, all patients completing the study demonstrated improvements in lesion size following treatment, with follicular repigmentation in all cases. |
Radakovic S.et al.3434 Radakovic S, Breier-Maly J, Konschitzky R, Kittler H, Sator P, Hoenigsmann H, et al. Response of vitiligo to once- vs. twice-daily topical tacrolimus: a controlled prospective, randomized, observer-blinded trial. J Eur Acad Dermatol Venereol. 2009;23:951-3., 2009 Controlled prospective, randomized, observer blinded trial |
15 (10 F, 5 M) Mean age 32 (range 10-61) |
|
Once or twice-daily application of 0.1% tacrolimus 6 months |
|
Twice-daily treatment for 6 months induced some repigmentation in 10 out of 15 (67%) lesions. Once-daily application of tacrolimus resulted in some repigmentation in 7 out of 15 (46%) lesions. |
Stinco G. et al.1515 Stinco G, Piccirillo F, Forcione M, Valent F, Patrone P. An open randomized study to compare narrow band UVB, topical pimecrolimus and topical tacrolimus in the treatment of vitiligo. Eur J Dermatol. 2009;19:588-93., 2009 Open randomized |
12 ( 2 M, 10 F) Mean age 43.2 (range 30-61) |
Face Neck Upper limbs Hands/Wrists Trunk Lower limbs Feet/Ankles |
Tacrolimus 0.1% ointment twice daily 24 weeks (6 months) |
Nine patients, 7 female and 2 male, described a heat sensation on the face during the first days of application; in one case the application of the ointment was reduced to once a day for two weeks, leading to disappearance of the symptoms. One female patient related soreness; 1 female patient reported pruritus on the eyelids associated with formication of the lips, and 1 female patient presented erythema of the bulbar conjunctiva. Five patients described the appearance of redflushing on their face after consuming a small amount of alcohol (a glass of beer or wine). All side effects resolved within 2-3 weeks. |
treatment outcome was calculated for each anatomical site according to a scale ranging from 0 to 4 and classified as “absent” , “ poor” (1-25%), “moderate” (26-50%), “good” (51-75%), and “excellent” (> 75%). All treated patients with vitiligo lesions localized on the face, neck and upper limbs obtained a variable repigmentation, from poor to excellent; for the other anatomical sites (hands/wrists, trunk and upper and feet/ankles) cases of lack of repigmentation were recorded. The only patient with lesions on the feet/ankles showed no signs of repigmentation. The best results of repigmentation were obtained for the face , followed by the neck, upper limbs and trunk and lower limbs, hands/wrists. |
Lo Y. H.et al2525 Lo YH, Cheng GS, Huang CC, Chang WY, Wu CS. Efficacy and safety of topical tacrolimus for the treatment of face and neck vitiligo. J Dermatol. 2010;37:125-9., 2010 Multicenter, open-label, non -comparative |
56 (19 M, 37 F) Mean age 44.4 (11–72) Patients were at least 16 years old |
|
Tacrolimus 0.1% ointment twice daily 3 months |
15 adverse events : namely acne in one, pruritus in five, dysesthesia in six and stinging in three. |
We noted that although 28.3% of the patients showed no response at week 4, all of them showed variable degrees of repigmentation at week 12. |
Udompataikul M.et al.2323 Udompataikul M, Boonsupthip P, Siriwattanagate R. Effectiveness of 0.1% topical tacrolimus in adult and children patients with vitiligo. J Dermatol. 2011;38:536-40., 2011 Open-label prospective |
38 (13 M, 25 F) Mean age 27.8 (22 adults and 20 children) |
Head and neck=24 lesions Trunk and extremities= 22 lesions |
Topical 0.1% tacrolimus twice daily 6 months |
Adverse events were observed in 28.6% of adult patients and 15% of children. These included burning sensation and erythema. |
The overall response rate, defined as at least some repigmentation, was 76.09%. |
Ho N. et al.2727 Ho N, Pope E, Weinstein M, Greenberg S, Webster C, Krafchik BR. A double-blind, randomized, placebo-controlled trial of topical tacrolimus 0.1% vs. clobetasol propionate 0.05% in childhood vitiligo. Br J Dermatol. 2011;165:626-32., 2011 Double-blind, randomized, placebo-controlled trial |
33 (17 F, 16 M) Mean age 8.4 (range 2-16) |
Face, the periorbital area was the most commonly affected area (25%) followed by the perioral area (13%), trunk (35%),upper extremity (31%), lower extremity (36%); seven patients had periungual, four perineal and one vulval, involvement. |
Tacrolimus 0.1% ointment 6 months |
Folliculitis |
Successful response was defined as repigmentation of > 50%. Responded successfully: 58% facial 23% non-facial. |
Silverberg J.I.et al.1111 Silverberg JI, Silverberg NB. Topical tacrolimus is more effective for treatment of vitiligo in patients of skin of color. Journal of drugs in dermatology: JDD 2011;10:507-10., 2011 Retrospective cohort |
90 (35 M, 55 F) Mean age 25.6 years |
Sixty-six patients had vitiligo lesions on the body, 65 patients on the face |
Topical 0.03% tacrolimus ointment for children aged 2-15 years 0.1% ointment for children aged 16 or more At least 3 months |
|
Repigmentation was good in all patients. More than 75% repigmentation of body lesions was noted in 62.5% of subjects with Fizpatrick types 3-4, compared with only 33.3 percent of Fizpatrick 1-2 and 21.7% of Fitzpatrick 5-6. |
Bhuvana K.et al.3535 Bhuvana K, Sarala N, Singh G, Kumar TN. Effect of 0.1% tacrolimus ointment in localized vitiligo: an open uncontrolled trial. Indian J Dermatol. 2011;56:445-6., 2011 Open uncontrolled trial |
55(30F,25M) Mean age 30 (range 3 57) |
Thirty-seven patients had 1% of body surface area involved, followed by 11 patients with 2% involvement. Also, 3 and 4% of body surface area was involved in four and three patients, respectively. In 32 patients, single region was affected; 20 patients had lesions on the face, especially the lips, eyelids, and ears. |
Tacrolimus ointment 0.1% twice daily 3 months |
|
Of the 55 patients, 36 showed response to treatment and 19 showed no response after 3 months. |
Tamler C.et al.2222 Tamler C, Duque-Estrada B, Oliveira PA, Avelleira JC. Tacrolimus 0,1% ointment in the treatment of vitiligo: a series of cases. An Bras Dermatol. 2011;86:169-72., 2011 Case series |
10 (4 F, 6 M) |
Face, neck and limbs |
Tacrolimus 0,1% ointment 4 months |
Mild burning (2 patients) |
Extremities and chest >50% repigmentation in 27% of cases. Six patients with lesions on the cephalic region showed >75% of repigmentation. |
Kathuria S.et al.1717 Hartmann A, Löhberg L, Keikavoussi P, Eichner S, Schuler G. Segmental vitiligo: a randomized controlled trial to evaluate efficacy and safety of 0.1% tacrolimus ointment vs 0.05% fluticasone propionate cream. Acta Derm Venereol. 2014;94:585-7., 2012 Randomized controlled trial |
29 (13 F, 16 M) Mean age 14 (range 5-55) |
|
0.1% tacrolimus ointment twice daily 6 months |
|
Only 5.3% patients with tacrolimus had >50% repigmentation, showing the limitation of the drug. |
Sahni K.et al.1212 Sahni K, Gupta V, Khanna N. Hyperpigmentation in photo exposed patches of vitiligo following tacrolimus therapy. Indian Dermatol Online J. 2014;5:164-6., 2014 Case report |
1 (M) 23 years old |
Scalp, periorbital regions, elbows, thighs, legs, and feet |
Topical tacrolimus 0.03% once daily 2 months |
Hyperpigmentation over the periorbital macules. |
There was some perifollicular repigmentation in most of the other vitiligo lesions. |
Hartmann A. et al.1616 Hartmann A, Lohberg L, Keikavoussi P, Eichner S, Schuler G. Treatment of Generalised Vitiligo with Tacrolimus 0.1% Ointment vs. UVB Intense Pulsed Light Phototherapy: A Pilot Study. Acta Derm Venereol. 2014;94:585-7., 2014 Open-label comparative prospective |
11 (8F,3M) Mean age 41 |
Depigmented lesions on the face, trunk, and extremities of the right side, on the shins |
Tacrolimus 0.1% ointment twice daily with overnight hydrocolloid dressing |
Initial mild prickling |
After 9 months, 38% of lesions on the tacrolimus-treated side on the trunk showed repigmentation. Four patients showed moderate to excellent repigmentation. |
Baldo A. et al2626 Baldo A, Lodi G, Di Caterino P, Monfrecola G. Vitiligo, NB-UVB and tacrolimus: our experience in Naples. G Ital Dermatol Venereol. 2014;149:123-30., 2014 Comparative randomized study |
48 (32F,12M) Mean age 27 years (range 6-67 years) |
Face/neck Hands Trunk Arms/legs |
Tacrolimus ointment 0.1% Twice a day 36 weeks (9 months) |
Erythema and folliculitis-like manifestations (2 patients discontinued the therapy because of side effects). |
Partial repigmentation 71% of patients. No repigmentation 14% of patients. |