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Taking people in GermanyPhase 3

Tests a new methylprednisolone aceponate cream for mild to moderate atopic dermatitis

Tests a new steroid cream in people with mild to moderate atopic dermatitis.

Key facts

Who runs it
Dermapharm AG
Where
Berlin, Bonn, Crimmitschau, Halle, Ibbenbüren, Kiel, Potsdam, Simmern, and Vechta, GermanySee the 9 sites
Registry title
Clinical study to compare two cutaneous creams with the active substance methylprednisolone aceponate 0.1% and one cutaneous cream without active substance for patients with atopic dermatitis
Status
Recruiting
Phase
Phase 3
People taking part
330 people, planned
Started
18 Jul 2023
Expected to end
30 Apr 2028
Type of study
Interventional
Record updated
26 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 6 years or older with a flare of mild to moderate atopic dermatitis. It compares two methylprednisolone aceponate 0.1% creams with a cream without active substance.

Age
6 years or older
Sex
Women and men (all sexes)
Disease stage
Acute flare of atopic dermatitis, mild (IGA score 2) or moderate (IGA score 3). The skin affected must be at least 10% and not more than 40% of the body surface (BSA).
Earlier treatment
Cannot have had any systemic treatment of atopic dermatitis in the last 4 weeks. Cannot have had any topical treatment or physical therapy (such as UV radiation) in the test area in the last 2 weeks.

Main reasons for not taking part

  • Pregnancy, planned pregnancy or breastfeeding
  • Skin infections or other skin diseases in the treatment area (for example herpes, tuberculous or syphilitic processes, rosacea, acne vulgaris)
  • Glaucoma or cataract
  • Known intolerance or allergy to methylprednisolone aceponate or other ingredients
  • Taking part in another clinical study in the last 30 days, or in this study before

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Women, men and children/adolescents of both sexes ≥ 6 years of age
  • Written consent to study participation after patient information by the investigator
  • In case of patients below the age of 18: Written consent to study participation of legal guardian(s) and child/adolescent patient after an age-appropriate patient- and legal guardian(s)- information session by the investigator
  • Acute flare of atopic dermatitis according to the Investigator´s Global Assessment (IGA score 2 (mild) or 3 (moderate))
  • Affected body surface (BSA) between at least 10% and not more than 40%
  • For women of childbearing potential: Application of an established highly efficient contraceptive method during the whole study
  • For all female patients of childbearing potential: Urine pregnancy test

Who cannot take part

  • Any systemic treatment of the atopic dermatitis within the last 4 weeks prior to study inclusion
  • Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
  • Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
  • Participation in another clinical study within the last 30 days prior to inclusion in this study
  • Any topical treatment (e.g. topical immunomodulators such as tacrolimus ointment, pimecrolimus cream, topical antibiotics, topical glucocorticoids, other topical anti-inflammatory medication) or physical therapy (e.g. UV radiation) of the atopic dermatitis in the test area 2 weeks prior to study inclusion
  • Severe acute or chronic concomitant disease with severe impairment of the general condition
  • Presence of viral infections (such as herpes or varicella), rosacea, perioral dermatitis, ulcera, acne vulgaris, atrophic skin diseases and vaccination skin reactions in the area to be treated
  • Presence of bacterial and/or mycotic skin diseases in the treatment area
  • Known intolerance or hypersensitivity against methylprednisolone aceponate or any of the other ingredients in the study medication
  • Reasonable doubt concerning the co-operation of the patient
  • Participation in this study at an earlier date
  • Women with existing or intended pregnancy or during lactation
  • Presence of tuberculous or syphilitic processes in the treatment area
  • Current diagnosis of glaucoma or cataract
  • Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area, which would interfere with evaluations

Where in Germany

  • Praxis Dr. Julia ReichleBerlin, GermanyTaking people
  • MVZ Dermatologisches Zentrum Bonn GmbHBonn, GermanyTaking people
  • Hautarztpraxis Dr. PfennigCrimmitschau, GermanyTaking people
  • Praxis Dr. med. Abdou ZarzourHalle, GermanyTaking people
  • Hautarztpraxis Dr. Offers und Dr. AdaminiIbbenbüren, GermanyTaking people
  • HautarztpraxisKiel, GermanyTaking people
  • Haut-und Lasercentrum Potsdam - Dr. med. Tanja FischerPotsdam, GermanyTaking people
  • Haut- und Laserzentrum Hunsrück, Gesundheitszentrum Simmern, Dermatologisches StudienzentrumSimmern, GermanyTaking people
  • Hautarztpraxis KockVechta, GermanyTaking people

About the trial

What the trial wants to find out

Assessment of efficacy and safety of a new methylprednisolone aceponate 0.1% cream in comparison with the approved preparation Advantan 0.1% cream and the underlying vehicle in patients with mild to moderate atopic dermatitis

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Double-blind, randomised clinical study comparing efficacy and safety of Methylprednisolone Aceponate 0.1% Cream (Test) vs. Advantan(R) 0.1% Cream (Reference) vs. Vehicle in patients with mild to moderate atopic dermatitis
Plain-language title
Tests a new methylprednisolone aceponate cream for mild to moderate atopic dermatitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
26 October 2026