Open-label, single-arm, single-center clinical study on the effectiveness and safety of a moisturizer containing tocotrienol-rich composition in children with mild to moderate atopic dermatitis

How KN; Chang HW; Lai OM

doi:10.1111/jocd.15793

Open-label, single-arm, single-center clinical study on the effectiveness and safety of a moisturizer containing tocotrienol-rich composition in children with mild to moderate atopic dermatitis

How KN ¹ , Chang HW ² , Lai OM ³

Affiliations

¹ Dermatology Unit, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia
² Lipidware Sdn. Bhd., G-05, Jalan Maklumat, MTDC-UPM, Universiti Putra Malaysia, Serdang, Malaysia
³ Department of Bioprocess Technology, Faculty of Biotechnology and Biomolecular Sciences, Universiti Putra Malaysia, Serdang, Malaysia

J Cosmet Dermatol, 2023 Oct;22(10):2746-2754.

PMID: 37143441 DOI: 10.1111/jocd.15793

Abstract

BACKGROUND: Little is known about antioxidant efficacy of topical vitamin E on atopic dermatitis (AD) due to lack of controlled clinical studies.

AIM: The study evaluates the effectiveness and safety of a topical moisturizer containing tocotrienol-rich composition over 12 weeks on patients aged between 1 month and 12 years with mild to moderate AD.

METHODS: We conducted a 12 weeks, prospective, open-label clinical study on the effect of tocotrienol as an adjunct to conventional treatment. This study was approved by the Ethics Committee for Research Involving Human Subject. JKEUPM-2019-274 (NMMR-19-1588-49234).

RESULTS: Thirty AD patients with a mean age of 2.77 ± 3.05 were enrolled in the study. At week-12, significant reduction of investigator global assessment (63.4%), Patient-Oriented Scoring Atopic Dermatitis Index (PO-SCORAD) (65%), and SCORAD (52.3%) was noted (p

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.