BACKGROUND: Eczema is a common, chronic inflammatory skin disease characterized by itchy red
rashes and scaly skin that can significantly affect the quality of life of patients. Moisturizing creams and
emollients are often used to combat dryness and inflammation. The aim of this study was to demonstrate
the efficacy of a topical study product in reducing the appearance and symptoms of eczema.
OBJECTIVE: We performed an open-label, adaptive-design, pilot study evaluating the efficacy of the
AtopisTM product in reducing the appearance of eczema lesions and reducing the symptoms of itching,
scaling, and redness.
METHODS: Healthy subjects aged 18–75 years with mild to moderate eczema, which was determined
at screening visit, were enrolled in the study. Subjects topically applied the AtopisTM study product
twice daily on areas identified with skin lesions for 5 weeks. On a daily basis, subjects completed the
Visual Analog Scale for eczema symptoms — itching, scaling, and redness. Dermatologic assessments
for severity and size of lesions and Severity Scoring of Atopic Dermatitis (SCORAD) were also assessed
by a practitioner in the clinic at days 0, 7, 15, 30.
RESULTS: Forty subjects were screened and a total of 20 subjects completed the study. VAS Symptom
Score for Itching demonstrated statistically significant decreases from baseline to Weeks 2, 3, and 4
(p=0.001, p=0.011, p=0.031, respectively). In addition, VAS Symptom Score for Scaling demonstrated
statistically significant reductions from baseline to Weeks 2, 3, 4 (p=0.000, p=0.003, p=0.031, respectively).
VAS Symptom Score for Redness displayed statistically significant decreases from baseline to all
time points (p=0.005, p=0.001, p=0.043, respectively). Dermatologic assessments including SCORAD
Index demonstrated statistically significant reductions from baseline (20.61) to Day 30 (10.26) (49.11%;
p=0.04). Subjective measures of quality of life assessed through DLQI showed a statistically significant
reduction of 48.03% from baseline (7.60) to Day 30 (3.95) (p=0.031).
CONCLUSION: Topical application of AtopisTM study product for five weeks appears to be effective for
treatment of mild to moderate eczema as it significantly reduced the appearance of lesions as well as
symptoms associated including itching, scaling, and redness. The study product was safe and tolerable
for twice a day application as no adverse events were reported.
SOURCE OF FUNDING: Decima Health Ltd., Rangiora, New Zealand