A superiority study comparing two pharmaceutical skin care creams containing different humectants with a non-humectant containing skin care cream for the treatment of xerotic foot of persons with diabetes.

Conditions

xerotic skin on foot of subjects with diabetes

Brief summary

To demonstrate superiority of test products over a comparator in reducing xerosis on feet of subjects with diabetes by clinical assessment of the Xerosis Severity Scale from baseline until after 4 weeks treatment.

Detailed description

(1) Comparing the change in skin barrier integrity as demonstrated by the non-invasive biophysical measurements of trans epidermal water loss, skin hydration and skin pH between test products and comparator from baseline until 2 and 4 weeks of treatment. (2) Comparing the change in EQ-5D-5L between test products and comparator from baseline until after 4 weeks treatment. (3) Safety: Documentation and evaluation of adverse effects and assessing vital signs.

Ericsson A, Borgström K, Kumlien C, Gershater Annersten M, Ruzgas T, Engblom J, Gudmundsson P, Lazer V, Jankovskaja S, Lavant E, Ågren-Witteschus S, Björklund S, Salim S, Åström M, Acosta S.

2024-09-161 citations

10.1016/j.conctc.2024.101372

Interventions

DRUGOviderm

DRUG250 mg/g

DRUGkrem

DRUGCanoderm 5 % kräm

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To demonstrate superiority of test products over a comparator in reducing xerosis on feet of subjects with diabetes by clinical assessment of the Xerosis Severity Scale from baseline until after 4 weeks treatment.	—

Secondary

Measure	Time frame
(1) Comparing the change in skin barrier integrity as demonstrated by the non-invasive biophysical measurements of trans epidermal water loss, skin hydration and skin pH between test products and comparator from baseline until 2 and 4 weeks of treatment. (2) Comparing the change in EQ-5D-5L between test products and comparator from baseline until after 4 weeks treatment. (3) Safety: Documentation and evaluation of adverse effects and assessing vital signs.	—

Measure

Time frame

(1) Comparing the change in skin barrier integrity as demonstrated by the non-invasive biophysical measurements of trans epidermal water loss, skin hydration and skin pH between test products and comparator from baseline until 2 and 4 weeks of treatment. (2) Comparing the change in EQ-5D-5L between test products and comparator from baseline until after 4 weeks treatment. (3) Safety: Documentation and evaluation of adverse effects and assessing vital signs.

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Countries

Sweden

Outcome results

None listed