V0034CR01B
DrugCream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
NCT Number: NCT01467362
Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is associated with skin barrier dysfunction that facilitates an easier allergen penetration into the skin with an increased irritation and subsequent cutaneous inflammation. A lack of important stratum corneum intercellular lipids and an inadequate ratio between compounds enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy usually twice daily improves dryness and subsequently pruritus during the treatment of atopic dermatitis and especially improves the barrier function. Emollients make part of basic therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology and Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier alteration, measured by skin hydration, is a key element for evaluation of emollient treatment efficacy.
The primary objective of this study is to demonstrate the efficacy of the tested product (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient formula during 28 days.
Looking for future studies?
Notify Me2 year–6 year
All sexes
Interventional
Phase 3
Estonia, Tallinn
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days
cream, once a day (in the evening) during flares
Other names: Locapred
for the washing and cleaning
Other names: Pediatril
Time frame: During 28 days (Day 1, Day 7, Day 14, Day 21 and Day 28)
Time frame: Day 1, Day 14, Day 28, Day 56 and Day 84
Time frame: At Visit1 (Day 1) and at Day 56 and Day 84
Time frame: Day 1, Day 14, Day 28, Day 56 and Day 84
Time frame: Day1, Day 28, Day 56 and Day 84.
Time frame: Day 28 and Day 84
Time frame: at Day 28 and at Day 84
Time frame: Day 1, Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84
Time frame: Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84
Pierre Fabre Medicament
Industry
Efficacy of the V0034CR01B Emollient on Xerosis in Children With Atopic Dermatitis. Randomised, Vehicle-controlled, Parallel-groups, Double-blind Study With an Open Label Extension.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05461456
Atopic Dermatitis, Atopic Dermatitis Eczema
Dhaka, Ramna, Bangladesh
View Trial DetailsNCT00460083
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
San Diego, California, United States
View Trial DetailsNCT07014007
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Quatre Bornes, Mauritius
View Trial DetailsNCT05990725
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Augsburg, Germany
View Trial Details