Efficacy and Safety of Tacrolimus Ointment in Pediatric Patients with Moderate to Severe Atopic Dermatitis
Srisuphaluk Singalavanija MD*, Noppadon Noppakun MD**, Wanida Limpongsanuruk MD*, Wanee Wisuthsarewong MD***, Kobkul Aunhachoke MD****, Amornsri Chunharas MD*****, Siriwan Wananukul MD**, Rutsanee Akaraphanth MD******
Affiliation : * Dermatology Unit, Queen Sirikit National Institute of Child Health ** Department of Pediatrics, Chulalongkorn Hospital, Chulalongkorn University *** Department of Pediatrics, Siriraj Hospital, Mahidol University **** Department of Pediatrics, Pramongkutklao Hospital ***** Department of Pediatrics, Ramathibodi Hospital, Mahidol University ****** Dermatology Institution
Background : Atopic dermatitis (AD) is an immunological skin disease. It is common in pediatric populations
and often requires topical steroid treatment. Moderate to severe AD may not respond to topical steroids. They
often require systemic steroids, which may result in growth retardation. Protopic, a non-steroid, tacrolimus
based ointment which is a calcinurin inhibitor has been proved to be effective in caucacian with AD.
Objective : To evaluate safety and efficacy of 0.03% tacrolimus ointment (Protopic(cid:31)) in moderate to severe AD
in pediatric patients age 2-12 years.
Materials and Methods : This was a one month multicenter open-label clinical trial using tacrolimus ointment
twice daily in 61 subjects with moderate to severe AD from September to December 2004. Efficacy assessments
were measured by Physician’s Global Evaluation of Clinical Response (PhGECR), Eczema area and Severity
Index (EASI), Patient’s Global Evaluation of Clinical Response (PaGECR), and Quality of Life (QOL). Safety
assessment was measured by incidence rate of adverse events.
Results : Fifty-eight patients completed the studies. Twenty-two patients were male; thirty-nine patients
were female. Twenty-nine patients had moderate AD. Thirty-two patients had severe AD. Three cases had
discontinued treatment at the third week due to increase in severity. Over all PhGECR were significantly
increased, 94% showed moderate improvement in PhGECR at week 4 or end of treatment (EOT)and 83% had
better improvement in PaGECR at EOT. Within 7 days, tacrolimus demonstrated rapid onset in reduction of
EASI score and itch in patients. Mean QOL were significantly decreased at the end of the present study.
Incidence of adverse events included application site burning (21%), itching (17%), pruritus (9%),
infections(3%), and erythema and folliculitis (2%) . Burning sensation, erythema, pruritus and itching were
resolved after the first week.
Conclusion : Topical tacrolimus ointment is effective and safe in moderate to severe AD. It significantly im-
proved PhGECR, EASI, PaGECR, and QOL in pediatric patients after the first week of treatment and continued
through the end of the study. The major adverse events were burning, itching, and pruritus, which were
resolved within the first week of therapy.
Keywords : Aptopic dermatitis, Tacrolimus ointment, Pediatric patient
