Moisturiser effect on atopic dermatitis relapse prevention in children

Trial details

Who runs it

Aco Hud Nordic AB

Trial code

EU 2022-501184-41-00

Record updated

2023. október 23.

Original description

To demonstrate superiority of a newly developed moisturiser in preventing eczema relapse in children with AD compared to a reference cream.Read full original descriptionShow less

A phase IV randomised, double-blind, parallel-design, controlled multi-center trial of a NOVel moisturiser for Atopic dermatitis: effect on relapse prevention in children, NOVA II

To demonstrate superiority of a newly developed moisturiser in preventing eczema relapse in children with AD compared to a reference cream.

Inclusion: Children >2- ≤12 years old (male and female); Diagnosis of AD according to UK working party 1994,(32) i.e.: a) Any itching skin condition and b) Three or more of the following: (i) History of flexural involvement, e.g. front of elbows, behind the knees, front of ankles, around the neck (ii) Personal history of other atopic disease, e.g. asthma or hay fever (iii) History of generally dry skin in the last 12 months (iv) Visible flexural dermatitis, e.g. front of elbows, behind the knees, front of ankles, around the neck (v) Onset below age 2; Visible mild (≤ 15 ) to moderate (> 15 to < 40) eczema according to the objective SCORAD, which ideally should be symmetrical in localization and/or face; Participants with at least two relapses during last 12 months, including the one at the screening visit; Participants willing to agree to avoid any other prescription/OTC/natural remedies treatments for eczema and/or dry skin; Legally acceptable representatives (i.e. parent(s) or guardians) of participant according to local regulations have provided the appropriate written informed consent and participant has given their assent (as age appropriate).

Exclusion: Any treatment with immunomodulatory systemic medications, e.g. dupilumab, omalizumab or other biologics, JAK inhibitors, methotrexate, cyclosporine, oral or systemic corticosteroids (except inhaled corticoid spray for allergic asthma if on a stable dose and asthma status well controlled) within 3 months prior screening and throughout the study; Any treatment with TCS' (other than the corticosteroids prescribed in the stabilisation phase) or other established topical treatment for AD within 2 weeks prior screening and throughout the study; Phototherapy (UVB, UVA, UVA1, PUVA) within 4 weeks prior screening and throughout the study; Asthma which is not stable during the last 6 months prior screening as per clinical judgement (reflected by symptoms>2 days per week or nighttime awakening with symptoms > 2 times per week or reduced normal activities due to asthma, PEF <80% of predicted value); Any infectious disease of the skin within 4 weeks prior screening; Any infectious disease including unexplained diarrhea within 2 weeks prior screening; History of immunomodulatory or immunosuppressant diseases e.g. lymphoproliferative diseases, diabetes mellitus, malignancies of any organ within 5 years prior screening; History of intolerance to topical corticosteroids or any condition which prohibits or does not recommend treatment with topical corticosteroids e.g. atrophy of the skin; Enrolment in any investigational study or use of an investigational product (oral or topical) within 3 months prior to the screening visit; Participants unwilling to refrain from using prohibited medication including moisturizers (other than the study treatments); Antibiotic, antimycotic or antiviral treatment (oral or topical) within 2 weeks prior screening and throughout the study; Viral diseases (e.g. chicken pocks, shingles), rosacea, perioral dermatitis, ulcers, acne vulgaris,skin atrophy, vaccination reaction in the treatment area; Skin infections caused by bacteria and fungi; Any immunosuppression or history of unusual frequent, recurrent, severe or prolonged infections; Participants with known or suspected allergies or contraindications to any of the study product ingredients (including products for the treatment in the stabilization phase); Participants with severe eczema, as defined by objective SCORAD; Moisturisers, home remedies or other topical products on the study area eczemas, except for the AxMP (during the stabilisation phase) and the IP in the maintenance phase; Diaper rash in the treatment area; Participants with eczema on the hands only; Participants/participants’ parent(s) and/or legal guardian(s) who, in the opinion of the Investigator, are unable to complete all study related visits and/or procedures; Pregnancy confirmed by a positive human chorionic gonadotropin (hCG) urine test for females of childbearing potential; Planning to participate in any other clinical study during participation in this current study, including the maintenance phase.

EU CTIS 2022-501184-41-00