Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 32 for:    PANTHENOL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04016025
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Peter Elsner, Jena University Hospital

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

Condition or disease Intervention/treatment Phase
Adherence, Patient Chronic Eczema Behavioral: Adherence to topical standard therapy assessed Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized single-blind
Masking: Single (Participant)
Masking Description: Only patients enrolled in the study will not know in which vehicle they will receive the Standard therapeutical drug
Primary Purpose: Treatment
Official Title: Randomized Single-blind Study on the Adherence to Treatment With Topical Methylprednisolone Aceponate (Advantan®) in Different Vehicles (AD-HERE)
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : January 15, 2021


Arm Intervention/treatment
Active Comparator: cream
Treatment with topical Methylprednisolone aceponate 0,1% cream (Advantan®) plus Basic care (Bepanthen® Sensiderm)
Behavioral: Adherence to topical standard therapy assessed
Adherence defined as percentage of patients applying at least aimed daily dose

Active Comparator: fatty ointment
Treatment with topical Methylprednisolone aceponate 0,1% fatty ointment (Advantan®) plus Basic care (Bepanthen® Sensiderm)
Behavioral: Adherence to topical standard therapy assessed
Adherence defined as percentage of patients applying at least aimed daily dose




Primary Outcome Measures :
  1. Adherence to treatment [ Time Frame: 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

  2. Measurement 1 [ Time Frame: 28 days; visit 1 (day 1) ]
    Hand surface [cm²]

  3. Measurement 2 [ Time Frame: 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28) ]
    Weight of topical drug container [mg]

  4. Individual amount of topical drug [ Time Frame: 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

  5. Truly applicated daily dose [ Time Frame: 28 days ]
    - individual amount of topical drug used [mg/cm²] by individual mean number of applications


Secondary Outcome Measures :
  1. Change of Hand Eczema [ Time Frame: 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28) ]
    Hand Eczema Severity Index (HECSI) Score: 0-360 Points (Total HECSI score = Sum (E, I, V, F, S, O) X Ex (Fingertips) + Sum (E, I, V, F, S, O) X Ex (Fingers except tips) + Sum (E, I, V, F, S, O) X Ex (Palm of hands) + Sum (E, I, V, F, S, O) X Ex (Back of hands) + Sum (E, I, V, F, S, O) X Ex (Wrists))

  2. Change of Hand Eczema [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  8. Current diagnosis of exfoliative dermatitis.
  9. Current diagnosis of glaucoma or cataract.
  10. Significant clinical infection on the hands which requires antibiotic treatment.
  11. Known or suspected hypersensitivity to component(s) of the IMP.
  12. Subjects with history of an immunocompromising disease (e.g. lymphoma, HIV).
  13. Former participation in this clinical trial.
  14. Current participation in any other interventional clinical trial.
  15. 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).
  16. Close affiliation with the investigator or other employees of the trial site (e.g. a close relative) or persons working at Jenapharm GmbH/Bayer Consumer Care AG or subject is an employee of sponsor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016025


Contacts
Layout table for location contacts
Contact: Deborah M Gregersen +4915232185057 DeborahMaria.Gregersen@med.uni-jena.de
Contact: Melanie Peckruhn, Dr. med. +4915232185339 melanie.peckruhn@derma.uni-jena.de

Sponsors and Collaborators
Jena University Hospital
Bayer
Investigators
Layout table for investigator information
Principal Investigator: Peter Elsner, Prof. Dr. med. University hospital Jena

Publications:

Layout table for additonal information
Responsible Party: Peter Elsner, Prof. Dr. med. P. Elsner, Head of Dermatology, Principal Investigator, Jena University Hospital
ClinicalTrials.gov Identifier: NCT04016025     History of Changes
Other Study ID Numbers: ZKSJ0119_AD-HERE
2019-001324-35 ( EudraCT Number )
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Methylprednisolone aceponate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents