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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.
EU CTIS ID: 2023-505897-13-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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)
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.