Tacrolimus ointment 0.1% in pityriasis alba: an open-label, randomized, placebo-controlled study.

Abstract

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.

• Authors: D Rigopoulos, S Gregoriou, C Charissi, G Kontochristopoulos, D Kalogeromitros, S Georgala
• Journal: The British journal of dermatology (Br J Dermatol) Vol. 155 Issue 1 Pg. 152-5 (Jul 2006) ISSN: 0007-0963 [Print] England
• PMID: 16792767 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Dermatologic Agents
• Immunosuppressive Agents
• Sunscreening Agents
• Tacrolimus

Topics

• Adolescent
• Adult
• Analysis of Variance
• Child
• Dermatologic Agents (therapeutic use)
• Double-Blind Method
• Female
• Humans
• Hypopigmentation (drug therapy, pathology)
• Immunosuppressive Agents (therapeutic use)
• Male
• Pityriasis (drug therapy, pathology)
• Pruritus (drug therapy, pathology)
• Skin (pathology)
• Statistics, Nonparametric
• Sunscreening Agents (therapeutic use)
• Tacrolimus (therapeutic use)