TITLE:
Blue Cap Is Effective and Safe for the Treatment of Atopic Dermatitis in Children
AUTHORS:
Mirjana Gajić-Veljić, Biljana Marenović, Margita Mijušković, Vesna Reljić, Danica Tiodorović, Danijela Popović, Sanja Zorić-Blagojević, Milica Vučinić, David Marquez-Soriano, Jovan Lalošević
KEYWORDS:
Pediatric Dermatology, Atopic Dermatitis, Piroctone Olamine, Skin Care
JOURNAL NAME:
Open Journal of Pediatrics,
Vol.14 No.3,
May
28,
2024
ABSTRACT: Background: Atopic dermatitis (AD) is the most common inflammatory skin disease in children. Treatment of AD is based on skin barrier repair and reduction of inflammation. We analyzed the efficacy and safety of activated piroctone olamine (APO)—Blue Cap—in children with AD. Materials and Methods: An open-label interventional clinical study was carried out at three clinical centers in Serbia. A total of 58 patients with AD, aged between 3 and 18 years were included and treated with Blue Cap Foam (100 ml; CATALYSIS S.L. Madrid)—Activated Piroctone Olamine—applied twice a day in the affected areas with eczema for 30 days and final assessment at 45 days from baseline. Photographic documentation, clinical evaluation, therapy effectiveness and safety questionnaires were assessed at baseline, 15, 30 and 45 days. Results: Our results demonstrated a significant reduction in signs (erythema, scaling, infiltration, excoriations, xerosis) and symptoms (pruritus) at weeks 2 and 4 of the study. At the end of the study, most patients had moderate (28.6%) to great (62.5%) disappearance of manifestations and moderate (25%) to great (71.4%) skin quality improvement. The effect and tolerability of the therapy were evaluated as very good in 66.1 % and 67.9% and good in about 14.3% and 17.9%, assessed by the investigator and patient, respectively. Three patients experienced a burning sensation at the beginning of the study, the side-effects were resolved as the patients continued applying the foam. After two weeks of cessation of the investigated foam, a significant percentage of patients experienced worsening in the final assessment done by the investigator as well as the participant. In the final assessment, a significantly high percentage (57.1%) of patients had a total reduction of manifestation, and a significant number of participants considered the applied product as treatment success, assessed by the investigator (62.5%) as well as the participants (66.4%). Conclusions: Blue Cap is effective and safe in children with AD, although further large-scale randomized controlled trials should confirm our study findings.