Propylene glycol for Atopic Dermatitis

Inclusion criteria

• {"criterion_text":"- •\tThe patient has given their written consent to participate in the study\n- •\tAge ≥ 18 years\n- •\t Patients with known AD or diagnosed with AD according to the Williams criteria [1] with visible atopic lesions on arms and/or legs. Two lesions on left respective right side with a size of 2 x 2 cm to 10 x 10 cm should be available, i.e., study areas. The largest lesion should not be more than 50% larger than the smallest lesion in length and width, i.e., the length of the largest selected lesion ≤ 1.5× the length of the smallest and the width of the largest selected lesion ≤ 1.5× width of the smallest lesion\n- •\t Moderate to severe form of AD, IGA ≥ 3 [2], a mEASI score on the defined study areas of ≥ 4 and with a difference between left study area to right study area of ≤ 1 and which, in the opinion of the Investigator, can achieve complete clearance with a class III corticosteroid treatment for approximately 4 weeks"}

Exclusion criteria

• {"criterion_text":"- • Eczema exclusively on the hands\n- •\tPatients assessed by the Investigator to have mild atopic dermatitis\n- •\tPatients treated for AD with systemic drugs, topical corticosteroids class IV and light treatment during the last 3 months\n- •\tAny concomitant medications that, in the opinion of the Investigator, could affect the study outcome\n- •\tKnown sensitivity or allergy to any of the study products\n- •\tAny condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (e.g., compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments or procedures\n- •\tPatients assessed by the Investigator to have poor compliance\n- •\tPatients assessed by the Investigator to have difficulty reading and understanding the local language\n- •\tPatients who are pregnant, breast feeding or planning to become pregnant during study participation"}

Primary endpoints

• {"endpoint_text":"- •\tTime to relapse of eczema (patient reported outcome [PRO]) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first","definition_or_measurement_approach":"Time to relapse measured as patient-reported outcome (PRO) on a defined study area from baseline until relapse or until end of maintenance phase, whichever occurs first."}

Secondary endpoints

• {"endpoint_text":"- •\t Time to relapse of eczema (PRO) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first","definition_or_measurement_approach":"Same PRO time-to-relapse measure on defined study area as described for primary endpoint."}
• {"endpoint_text":"- •\t Change in self-reported pruritus on defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, using Peak Pruritus Numerical Rating Scale (NRS)","definition_or_measurement_approach":"Change from baseline in self-reported pruritus on defined study area using Peak Pruritus Numerical Rating Scale (NRS), measured until relapse or end of maintenance phase."}
• {"endpoint_text":"- •\t Change in self-reported pruritus on defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, using Peak Pruritus Numerical Rating Scale (NRS) per time","definition_or_measurement_approach":"Repeated measures of Peak Pruritus NRS over time to assess change from baseline until relapse or end of maintenance phase."}
• {"endpoint_text":"- •\t Frequency of adverse events during the maintenance phase","definition_or_measurement_approach":"Counting and reporting frequency of adverse events occurring during the maintenance phase."}

Methods

• Study-specific adverts ('Annons') in Norway and Sweden (documents present for NO and SV).
• Recruitment managed via participating clinical sites/dermatology clinics in Sweden and a dermatology clinic in Norway (site list provided).
• Patient information and informed consent forms provided (documents in Swedish and Norwegian).
• Recruitment arrangements and patient recruitment procedure documents submitted for Norway and Sweden.

Sweden

Earliest CTIS Part Ii Submission Date

02-10-2025

Latest Decision Or Authorization Date

24-11-2025

Processing Time Days

53

Number Of Sites

9

Number Of Participants

71

Norway

Earliest CTIS Part Ii Submission Date

03-09-2025

Latest Decision Or Authorization Date

25-11-2025

Processing Time Days

83

Number Of Sites

1

Number Of Participants

7

Primary sponsor

Full Name

Galenica AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Scandinavian CRO AB

Responsibilities

sponsor duty codes: 1,11,5,6,7 (as listed in record)

Name

PharmaLex Denmark A/S

Responsibilities

sponsor duty code: 8 (as listed in record)

Third parties

• {"country":"Sweden","full_name":"Scandinavian CRO AB","duties_or_roles":"codes: 1,11,5,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"PharmaLex Denmark A/S","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}