A Clinical Study of Adherence to Methylprednisolone Aceponate in Different Carriers (AD-HERE)

Jena University Hospital

Status and phase

Completed

Phase 4

Conditions

Adherence, Patient

Chronic Eczema

Treatments

Behavioral: Adherence to topical standard therapy assessed

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04016025

ZKSJ0119_AD-HERE

2019-001324-35 (EudraCT Number)

Details and patient eligibility

About

Untersuchung der Adhärenz zur topischen Standardtherapie bei Patienten mit chronischem Handekzem in Abhängigkeit von der Galenik

Full description

Prospective, randomized, parallel grouped, single-blinded (investigator), monocentric objective assessment of the adherence to the treatment with topical methylprednisolone aceponate (Advantan®) depending on the type of vehicle in patients with hand eczema treated according to the current Guideline.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed and dated informed consent has been obtained.
Clinical diagnosis of chronic mild-to-moderate hand dermatitis with or without atopic etiology or background (according to IGA: at least mild at Visit 1).
Subjects (male or female) aged from 18 to 65 years.
In overall good health including well controlled diseases as determined by medical history, physical examination, vital signs and clinical laboratory.
Female subjects must be of either:
- non-childbearing potential, post-menopausal, or have a confirmed clinical history of sterility or,
- childbearing potential, provided there is a confirmed negative urine pregnancy test prior to exposure, to rule out pregnancy Female subjects of childbearing potential must be willing to use highly effective methods of contraception to avoid causing pregnancy from enrolment and until the last visit (V3).
Female subjects must not be breastfeeding.

Exclusion criteria

females who are pregnant or breast-feeding.
Systemic treatment with immunosuppressive drugs, retinoids or corticosteroids within 8 weeks prior to randomization.
Phototherapy (PUVA or UVB) on the hands within 4 weeks prior to randomization.
Topical applied treatment with immunomodulators (e.g. pimecrolimus or tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization.
Use of other treatment on the hands during the clinical trial except for the use of investigational medicinal product (IMP) and emollient provided by sponsor during the clinical trial.
Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization.
Concurrent skin diseases on the hands and/or integument with acute flare and/or skin lesions within the last 8 weeks.
Current diagnosis of eczema on the integument except for the hands.
Current diagnosis of exfoliative dermatitis.
Current diagnosis of glaucoma or cataract.
Significant clinical infection on the hands which requires antibiotic treatment.
Known or suspected hypersensitivity to component(s) of the IMP.
Subjects with history of an immunocompromising disease (e.g. lymphoma, HIV).
Former participation in this clinical trial.
Current participation in any other interventional clinical trial.
Subjects known or, in the opinion of the investigator, are unlikely to comply with the Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state).
Close affiliation with the investigator or other employees of the trial site (e.g. a close relative) or persons working at LEO Pharma A/S or Bayer Consumer Care AG or subject is an employee of sponsor.