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A randomised controlled trial of a moisturiser for treatment of dry skin in atopic dermatitis: effect on the skin barrier in adults with a history of eczema

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508560-29-00
Acronym
CSCI-SKT-B1001
Enrollment
55
Registered
2023-12-07
Start date
2023-12-07
Completion date
2024-03-14
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis

Brief summary

Comparison of IPs on Trans Epidermal Water Loss (TEWL) on visit 3 and visit 5 between: • test product vs no treatment • test product vs Propyless®

Detailed description

Comparison of test product vs 1) no treatment; 2) Propyless®; 3) Canoderm® for each of the following parameters:, Comparison of TEWL on Visit 3 and Visit 5 between test product vs Canoderm®., 2. Comparison of TEWL on Visit 3 between test product and comparators as well as no treatment., Comparison of difference to baseline (Visit 2) of TEWL on Visit 3 between test product and comparators as well as no treatment., Comparison of TEWL on Visit 5 between test product and comparators as well as no treatment., Comparison of difference to Visit 3 for scoring of SLS irritant reactions on Visit 5 between test product and comparators as well as no treatment., Comparison of scoring of SLS irritant reactions on Visit 5 between test product and comparators as well as no treatment., Comparison of redness assessment based on images [Picture analysis, USR-Clip] (redness on Visit 5 minus redness on Visit 3) between test product and comparators as well as no treatment., Comparison of capacitance measurements on Visit 3 between test product and comparators as well as no treatment., Comparison of difference to baseline (Visit 2) of capacitance measurements on Visit 3 between test product and comparators as well as no treatment., Comparison of skin pH on Visit 3 between test product and comparators as well as no treatment., Comparison of difference to baseline (Visit 2) of skin pH on Visit 3 between test product and comparators as well as no treatment., Comparison of product consumption (in gram) over 28 days of treatment between test product and comparators.

Interventions

DRUGSODIUM LAURILSULFATE
DRUGCanoderm 5 % kräm
DRUGAqua ad iniectabilia Braun Lösungsmittel zur Herstellung von Parenteralia
DRUGPropyless 200 mg/g kutan emulsion
DRUGMiniderm 20 % kräm
DRUGCARBAMIDE
DRUGCOMBINATIONS

Sponsors

ACO Hud Nordic AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Comparison of IPs on Trans Epidermal Water Loss (TEWL) on visit 3 and visit 5 between: • test product vs no treatment • test product vs Propyless®—

Secondary

MeasureTime frame
Comparison of test product vs 1) no treatment; 2) Propyless®; 3) Canoderm® for each of the following parameters:, Comparison of TEWL on Visit 3 and Visit 5 between test product vs Canoderm®., 2. Comparison of TEWL on Visit 3 between test product and comparators as well as no treatment., Comparison of difference to baseline (Visit 2) of TEWL on Visit 3 between test product and comparators as well as no treatment., Comparison of TEWL on Visit 5 between test product and comparators as well as no treatment., Comparison of difference to Visit 3 for scoring of SLS irritant reactions on Visit 5 between test product and comparators as well as no treatment., Comparison of scoring of SLS irritant reactions on Visit 5 between test product and comparators as well as no treatment., Comparison of redness assessment based on images [Picture analysis, USR-Clip] (redness on Visit 5 minus redness on Visit 3) between test product and comparators as well as no treatment., Comparison of capacitance measure—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026