A Clinical Study of Adherence to Methylprednisolone Aceponate in Different Carriers

Phase 4

Completed

• Conditions: Chronic Eczema; Adherence, Patient
• Interventions: Behavioral: Adherence to topical standard therapy assessed

• Registration Number: NCT04016025
• Lead Sponsor: Jena University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-11
• Study Start: 2020-12-02
• Primary Completion: 2022-03-11
• Study Completion: 2022-04-14
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-07
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Signed and dated informed consent has been obtained.

2. 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).

3. Subjects (male or female) aged from 18 to 65 years.

4. In overall good health including well controlled diseases as determined by medical history, physical examination, vital signs and clinical laboratory.

5. 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).

6. Female subjects must not be breastfeeding.

Exclusion Criteria

1. females who are pregnant or breast-feeding.
2. Systemic treatment with immunosuppressive drugs, retinoids or corticosteroids within 8 weeks prior to randomization.
3. Phototherapy (PUVA or UVB) on the hands within 4 weeks prior to randomization.
4. Topical applied treatment with immunomodulators (e.g. pimecrolimus or tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization.
5. 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.
6. Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization.
7. Concurrent skin diseases on the hands and/or integument with acute flare and/or skin lesions within the last 8 weeks.
8. Current diagnosis of eczema on the integument except for the hands.
9. Current diagnosis of exfoliative dermatitis.
10. Current diagnosis of glaucoma or cataract.
11. Significant clinical infection on the hands which requires antibiotic treatment.
12. Known or suspected hypersensitivity to component(s) of the IMP.
13. Subjects with history of an immunocompromising disease (e.g. lymphoma, HIV).
14. Former participation in this clinical trial.
15. Current participation in any other interventional clinical trial.
16. 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).
17. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fatty ointment	Adherence to topical standard therapy assessed	Treatment with topical Methylprednisolone aceponate 0,1% fatty ointment (Advantan®) plus Basic care (Bepanthen® Sensiderm)
cream	Adherence to topical standard therapy assessed	Treatment with topical Methylprednisolone aceponate 0,1% cream (Advantan®) plus Basic care (Bepanthen® Sensiderm)

Primary Outcome Measures

Name	Time	Method
Adherence to treatment	28 days	Adherence defined as percentage of patients applying at least aimed daily dose Adherence will be assumed, if; * truly applicated daily dose is at least 75% of prescribed daily dose and; * the individual mean number of applications per day is at least 0.85
Measurement 1	28 days; visit 1 (day 1)	Hand surface \[cm²\]
Individual amount of topical drug	28 days	- weight of topical drug container \[mg\] by hand surface \[cm²\] will be combined to individual amount of topical drug which will as well be the prescribed daily dose
Truly applicated daily dose	28 days	- individual amount of topical drug used \[mg/cm²\] by individual mean number of applications
Measurement 2	28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)	Weight of topical drug container \[mg\]

Secondary Outcome Measures

Name	Time	Method
Change of Hand Eczema	28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)	Investigator's global Assessment (IGA) Score: 0-4 Points (0=Clear, 1=Almost clear, 2=Mild, 3=Moderate, 4=Severe)

Trial Locations

Locations (1)

Jena University Hospital; 🇩🇪 Jena, Thuringia, Germany