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.
- Conditions
- Papulopustular Rosacea
- Registration Number
- 2023-505897-13-00
- Lead Sponsor
- Dermapharm AG
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 726
Women and men ≥ 18 years of age
Written consent to study participation after patient information by the investigator
Diagnosis of papulopustular rosacea according to generally accepted criteria
On the face, ≥ 15 and not more than 50 inflammatory lesions (e.g. papules and pustules), thereof ≤ 2 nodular lesions
Investigator`s Global Assessment (IGA) of rosacea severity grade 3 (moderate) or 4 (severe)
For all female patients 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 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)
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
Other severe acute or chronic concomitant disease with severe impairment of the general condition
Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
Reasonable doubt concerning the co-operation of the patient
Participation in another clinical study within the last 30 days prior to inclusion in this study
Participation in this study at an earlier date
Women with existing or intended pregnancy or during lactation
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
Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of rosacea
Known intolerance or hypersensitivity against ivermectin or any of the other ingredients in the study medication
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)
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)
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
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)
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
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change from baseline (Visit 1) to Visit 8 (EoT) assessed by the inflammatory lesion (papules and pustules) count Percent change from baseline (Visit 1) to Visit 8 (EoT) assessed by the inflammatory lesion (papules and pustules) count
- Secondary Outcome Measures
Name Time Method Evaluation of tolerability by the investigator and by the patient from Visit 2 to Visit 8 (EOT) Evaluation of tolerability by the investigator and by the patient from Visit 2 to Visit 8 (EOT)
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. 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.
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. 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.
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. 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.
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. 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.
Evaluation of the overall therapeutic success by the investigator and patient at day 84 ± 4 (EOT). Evaluation of the overall therapeutic success by the investigator and patient at day 84 ± 4 (EOT).
Incidence of adverse events (AEs) during the course of the study Incidence of adverse events (AEs) during the course of the study
Trial Locations
- Locations (14)
Hautarztpraxis Kock
🇩🇪Vechta, Germany
Studienzentrum Dr. med. Beate Schwarz Dermatologie und Allergologie
🇩🇪Langenau, Germany
Derma Science GmbH
🇩🇪Hamburg, Germany
Praxis Dr. med. Abdou Zarzour
🇩🇪Halle, Germany
Haut-und Lasercentrum Potsdam - Dr. med. Tanja Fischer
🇩🇪Potsdam, Germany
Pro Derma
🇩🇪Duelmen, Germany
Gemeinschaftspraxis Weber & Crainic
🇩🇪Augsburg, Germany
Magdeburger Company For Medical Studies & Services GmbH
🇩🇪Magdeburg, Germany
Gemeinschaftspraxis Drs. Grosskopf
🇩🇪Wallerfing, Germany
Praxis Dr. Julia Reichle
🇩🇪Berlin, Germany
Scroll for more (4 remaining)Hautarztpraxis Kock🇩🇪Vechta, GermanyChristian KockSite contact+494441999310info@praxiskock.de