A clinical study comparing the efficacy and safety of a new cream containing ivermectin with the efficacy and safety of the originator product Soolantra® Cream and a cream without ivermectin in patients with rosacea in the face with papules and pustules.

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

2 Dec 2024 → ongoing

Decision date (initial)

2024-11-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Dermapharm AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To compare the efficacy of Ivermectin cream (10 mg/g) vs. Soolantra® 10 mg/g cream vs. vehicle in reducing inflammatory lesions at Day 84± 4

Secondary objectives 7

1. To compare the efficacy of Ivermectin cream (10 mg/g) vs. Soolantra® 10 mg/g cream vs. vehicle in achieving clinical response of “success” at Day 84 ± 4
2. To compare the efficacy of Ivermectin cream (10 mg/g) vs. Soolantra® 10 mg/g cream vs. vehicle in reducing inflammatory lesions at all other time points
3. To compare the efficacy of Ivermectin cream (10 mg/g) vs. Soolantra® 10 mg/g cream vs. vehicle in reducing facial erythema at all time points
4. To compare the efficacy of Ivermectin cream (10 mg/g) vs. Soolantra® 10 mg/g cream vs. vehicle in changing of the IGA
5. To compare the efficacy of Ivermectin cream (10 mg/g) vs. Soolantra® 10 mg/g cream vs. vehicle on the overall therapeutic success
6. To compare the safety of Ivermectin cream (10 mg/g) vs. Soolantra® 10 mg/g cream vs. vehicle
7. To compare the tolerability of Ivermectin cream (10 mg/g) vs. Soolantra® 10 mg/g cream vs. vehicle

Conditions and MedDRA coding

Papulopustular Rosacea

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Women and men ≥ 18 years of age
2. Written consent to study participation after patient information by the investigator
3. Diagnosis of papulopustular rosacea according to generally accepted criteria
4. On the face, ≥ 15 and not more than 50 inflammatory lesions (e.g. papules and pustules), thereof ≤ 2 nodular lesions
5. Investigator`s Global Assessment (IGA) of rosacea severity grade 3 (moderate) or 4 (severe)
6. For all female patients of childbearing potential: Application of an established highly efficient contraceptive method during the whole study
7. For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start. The urine pregnancy test used must have a sensitivity down to at least 25 mIU/ml for human chorionic gonadotrophin (hCG) (High sensitivity pregnancy test)

Exclusion criteria 15

1. Presence of other forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other dermatoses that may be confounded with papulopustular rosacea, such as perioral dermatitis, facial keratosis pilaris, seborrheic dermatitis and acne
2. 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
3. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of rosacea
4. Known intolerance or hypersensitivity against ivermectin or any of the other ingredients in the study medication
5. Use within 6 months prior to baseline of oral retinoids (e.g. isotretinoine) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed)
6. Use within 30 days prior baseline or during the study of topical facial treatment with retinoids, benzoyl peroxide, antibiotics, corticosteroids, immunomodulators (like e.g. tacrolimus), or other topical rosacea treatment (e.g. azelaic acid, metronidazole, brimonidine, oxymetazoline)
7. Use within 30 days prior to baseline of systemic antibiotics known to have an impact on the severity of facial rosacea (like e.g. tetracycline and its derivatives doxycyclin or minocyclin, macrolides (like erythromycine, clarithromycine, azithromycine), or systemic corticosteroids
8. Exposure to excessive UV radiation within two weeks prior baseline, or the subject is planning exposure during the study (e.g. occupational exposure to the sun, planned holidays in the sun during the study, phototherapy, tanning salon)
9. Subjects with moderate or severe rhinophyma, dense telangiectases, or plaque-like facial edema, or ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic treatment
10. Other severe acute or chronic concomitant disease with severe impairment of the general condition
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. Percent change from baseline (Visit 1) to Visit 8 (EoT) assessed by the inflammatory lesion (papules and pustules) count

Secondary endpoints 7

1. Proportion of subjects with a clinical response of “success”, i.e. the percentage of subjects with an IGA score of “0 = Clear” or “1 = Almost Clear”, at Day 84 ± 4.
2. Percent change and absolute change in inflammatory lesion (papules and pustules) count between baseline (Visit 1) and Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, respectively.
3. Change in the assessment of facial erythema between baseline (Visit 1) and Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, and Visit 8, respectively.
4. Change of the Investigator`s Global Assessment (IGA) between baseline (Visit 1) and Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7 and Visit 8, respectively. Changes will be calculated as baseline- follow-up.
5. Evaluation of the overall therapeutic success by the investigator and patient at day 84 ± 4 (EOT).
6. Incidence of adverse events (AEs) during the course of the study
7. Evaluation of tolerability by the investigator and by the patient from Visit 2 to Visit 8 (EOT)

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 2

Locations

1 EU/EEA country · 14 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 8 files

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

Application history

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