Clinical study to compare two cutaneous ointments with the active substance methylprednisolone aceponate 0.1% and one cutaneous ointment without active substance for patients with atopic dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dermapharm AG

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

26 Jul 2021 → ongoing

Decision date (initial)

2024-08-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Dermapharm AG

External identifiers

EU CT number

2024-514548-10-01

EudraCT number

2019-002686-35

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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

Secondary objectives 5

1. Percent change of Eczema Area and Severity Index (EASI) between visits
2. Percent change of the total affected body surface area (BSA) between visits, and between baseline and week 3 (EOT)
3. Change of the Investigator’s Global Assessment (IGA) between visits, and between baseline and week 3 (EOT)
4. Evaluation of Overall Therapeutic Success by the investigator and patient at week 3 (EOT)
5. Patient´s assessment of severity of pruritus

Conditions and MedDRA coding

Mild to moderate atopic dermatitis

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Women, men and children/adolescents of ≥ 6 years of age
2. Written consent to study participation after patient information by the investigator
3. 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
4. Acute flare of atopic dermatitis according to the Investigator´s Global Assessment (IGA score 2 (mild) or 3 (moderate))
5. Affected body surface (BSA) between at least 10% and not more than 40%
6. For women of childbearing potential1: Application of an established highly efficient contraceptive method2 during the whole study
7. For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start

Exclusion criteria 15

1. Any systemic treatment of the atopic dermatitis within the last 4 weeks prior to study inclusion
2. 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
3. Presence of tuberculous or syphilitic processes in the treatment area
4. 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.
5. Presence of bacterial and/or mycotic skin diseases in the treatment area
6. Current diagnosis of glaucoma or cataract
7. Known intolerance or hypersensitivity against methylprednisolone aceponate or any of the other ingredients in the study medication
8. Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area, which would interfere with evaluations
9. Severe acute or chronic concomitant disease with severe impairment of the general condition
10. 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
11. Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
12. Reasonable doubt concerning the co-operation of the patient
13. Participation in another clinical study within the last 30 days prior to inclusion in this study
14. Participation in this study at an earlier date
15. Women with existing or intended pregnancy or during lactation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of the study is the percent change from baseline (Visit 1) to Visit 4 (EOT) assessed by Eczema Area and Severity Index (EASI)

Secondary endpoints 5

1. Percent change of Eczema Area and Severity Index (EASI) between visits
2. Percent change of the total affected body surface area (BSA) between visits, and between baseline and week 3 (EOT)
3. Change of the Investigator’s Global Assessment (IGA) between visits, and between baseline and week 3 (EOT)
4. Evaluation of Overall Therapeutic Success by the investigator and patient at week 3 (EOT)
5. Patient´s assessment of severity of pruritus

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dermapharm AG

Sponsor organisation

Dermapharm AG

Address

Lil-Dagover-Ring 7, Geiselgasteig Geiselgasteig

City

Gruenwald

Postcode

82031

Country

Germany

Scientific contact point

Organisation

Dermapharm AG

Contact name

Anje Schmidt

Public contact point

Organisation

Dermapharm AG

Contact name

Anje Schmidt

Third parties 2

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

5 submissions — initial application plus substantial / non-substantial modifications