Clinical study to compare the therapeutic effects of two ointments with the active substances clotrimazole and betamethasone dipropionate and of one ointment without active substance for patients with moderate to severely inflamed infection of the skin through yeast fungi.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dermapharm AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

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

Trial duration

8 Mar 2022 → ongoing

Decision date (initial)

2024-05-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Dermapharm AG

External identifiers

EU CT number

2022-501415-14-00

EudraCT number

2021-003790-65

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Assessment of efficacy and safety of a new ointment with clotrimazole (10 mg/g) and betamethasone dipropionate (0.64 mg/g) (Mecloderm®) in comparison with the authorised medicinal product Lotricomb® Ointment and the underlying vehicle of Mecloderm® in patients with moderately to severely inflamed candidiasis of the skin.

Secondary objectives 1

1. see endpoints

Conditions and MedDRA coding

moderate to severely inflamed candidiasis of the skin

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Women and men ≥ 18 years of age
2. Written consent to study participation after thorough information of the patient through the investigator or another medical competent member of the study team
3. Diagnosis of candidiasis of the skin based on clinical symptoms
4. Positive mycological result of a swab revealing at least a moderate number of fungi, microscopically proven
5. Sum score of all clinical parameters (erythema, exudation, dysesthesia/burning, maceration) ≥ 7
6. At least moderate severity of inflammation parameters erythema and exudation (i.e. score value ≥ 2)
7. For women of childbearing potential: Application of an highly effective contraceptive method during the whole study
8. For women of childbearing potential: Pregnancy test with negative result prior to study start

Exclusion criteria 13

1. The treatment area exceeds 10% of the body surface
2. Topical treatment in the observation area during the last 7 days prior to study inclusion
3. Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster, varicella), lues or tuberculosis of the skin, inoculation reactions, rosacea or rosacea-like dermatitis, perioral dermatitis, acne, primary purulent skin infections (like e.g. folliculitis), atrophied skin, wounds, ulceration, suspected additional bacterial infection
4. Necessity of application of the study medication in the area around the eyes
5. Systemic treatment with antimycotics and/or glucocorticoids within the last 4 weeks prior to study inclusion
6. Known intolerance or hypersensitivity against clotrimazole or other imidazole antimycotics, betamethasone dipropionate or other glucocorticoids, or any of the other ingredients in the study medications
7. Other severe acute or chronic concomitant disease with severe impairment of the general condition
8. 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
9. Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
10. Reasonable doubt concerning the co-operation of the patient
11. Participation in another clinical study within the last 30 days prior to inclusion in this study
12. Participation in this study at an earlier date
13. Women with existing or intended pregnancy or during lactation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number (percentage) of patients with treatment success (defined as sum score of clinical parameters ≤ 2 and all individual score values ≤ 1 and negative mycological result) at the main examination (EOT visit 3 after 14 days).

Secondary endpoints 5

1. Change of the sum score of clinical parameters between baseline and follow-up visits, and between main examination (EOT) and final examination
2. Number (percentage) of patients with mycological success (negative mycological cultivation and/or negative microscopical result) at visit 3 (EOT) and at the final visit (visit 4)
3. Evaluation of therapeutic success at visit 2 and EOT by the investigator and by the patient
4. Evaluation of overall therapeutic success by the investigator at the final examination
5. Number (percentage) of patients with clinical relapse/re-infection at the final examination visit

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

Department of Clinical Research

Public contact point

Organisation

Dermapharm AG

Contact name

Department of Clinical Research

Third parties 3

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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