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Tacrolimus ointment 0·1% in pityriasis alba: an open‐label, randomized, placebo‐controlled study
Author(s) -
Rigopoulos D.,
Gregoriou S.,
Charissi C.,
Kontochristopoulos G.,
Kalogeromitros D.,
Georgala S.
Publication year - 2006
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/j.1365-2133.2006.07181.x
Subject(s) - hypopigmentation , medicine , tacrolimus , phototype , dermatology , adverse effect , pityriasis , placebo , randomized controlled trial , surgery , transplantation , alternative medicine , pathology
Summary Background Pityriasis alba (PA) is a frequent reason for dermatological consultation because of its chronic course, tendency to relapse and aesthetic impact. Objectives In view of its strong association with atopic dermatitis, the objective of this open‐label study was to assess the efficacy and safety of tacrolimus ointment in the treatment of PA compared with the efficacy of moisturizers. Patients/methods The study population consisted of 60 individuals of phototype III or IV according to Fitzpatrick's classification, aged 6–21 years. Patients were randomly assigned to one of two groups. Subjects in group A were instructed to apply tacrolimus ointment 0·1% twice daily, 12 h apart, on all hypopigmented macules. Standard moisturizers with SPF 20 sunscreen were used on all lesions applied at least 30 min apart from the tacrolimus ointment. Subjects in group B used solely the same moisturizers with sunscreen. Hypopigmented areas were evaluated at baseline and weeks 0, 3, 6 and 9 by investigators for scaling, hypopigmentation and pruritus on a scale of 0–3. Patient satisfaction was also recorded on a scale of 0–3. All adverse effects were recorded. Results A statistically significant improvement through time, in hypopigmentation, pruritus and scaling was observed in both groups during the course of 9 weeks. Hypopigmentation resolved from a baseline score of 2·38 ± 0·64 to 1·15 ± 0·54 at week 3, 0·46 ± 0·51 at week 6 and 0·00 ± 0·00 at week 9 for the group applying tacrolimus ointment 0·1%. The difference in improvement between the two groups was statistically significant on all three assessments for hypopigmentation ( P < 0·001), and for pruritus on week 6 and 9 assessments ( P < 0·05). Three patients (11·5%) in the tacrolimus group reported a mild transient sensation of burning. All patients in the tacrolimus group reported they were completely satisfied or just satisfied with the treatment compared with only 50% of patients using the placebo. Conclusions Tacrolimus ointment 0·1% appears to be an effective and safe treatment for PA.