IVERMECTIN for Papulopustular rosacea

Inclusion criteria

• {"criterion_text":"- Women and men ≥ 18 years of age"}
• {"criterion_text":"- Written consent to study participation after patient information by the investigator"}
• {"criterion_text":"- Diagnosis of papulopustular rosacea according to generally accepted criteria"}
• {"criterion_text":"- On the face, ≥ 15 and not more than 50 inflammatory lesions (e.g. papules and pustules), thereof ≤ 2 nodular lesions"}
• {"criterion_text":"- Investigator`s Global Assessment (IGA) of rosacea severity grade 3 (moderate) or 4 (severe)"}
• {"criterion_text":"- For all female patients of childbearing potential: Application of an established highly efficient contraceptive method during the whole study"}
• {"criterion_text":"- 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

• {"criterion_text":"- 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"}
• {"criterion_text":"- Other severe acute or chronic concomitant disease with severe impairment of the general condition"}
• {"criterion_text":"- Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data"}
• {"criterion_text":"- Reasonable doubt concerning the co-operation of the patient"}
• {"criterion_text":"- Participation in another clinical study within the last 30 days prior to inclusion in this study"}
• {"criterion_text":"- Participation in this study at an earlier date"}
• {"criterion_text":"- Women with existing or intended pregnancy or during lactation"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of rosacea"}
• {"criterion_text":"- Known intolerance or hypersensitivity against ivermectin or any of the other ingredients in the study medication"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- Percent change from baseline (Visit 1) to Visit 8 (EoT) assessed by the inflammatory lesion (papules and pustules) count","definition_or_measurement_approach":"Percent change in inflammatory lesion (papules and pustules) count from baseline (Visit 1) to Visit 8 (End of Treatment)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion of subjects achieving IGA score 0 or 1 at Day 84 ± 4."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Percent and absolute change in inflammatory lesion count at each listed visit versus baseline."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change in facial erythema assessment at each listed visit versus baseline."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change in IGA score at each listed visit compared to baseline (calculated as baseline minus follow-up)."}
• {"endpoint_text":"- Evaluation of the overall therapeutic success by the investigator and patient at day 84 ± 4 (EOT).","definition_or_measurement_approach":"Investigator and patient assessment of overall therapeutic success at Day 84 ± 4."}
• {"endpoint_text":"- Incidence of adverse events (AEs) during the course of the study","definition_or_measurement_approach":"Reported incidence (number and proportion) of adverse events during the study period."}
• {"endpoint_text":"- Evaluation of tolerability by the investigator and by the patient from Visit 2 to Visit 8 (EOT)","definition_or_measurement_approach":"Investigator and patient-rated tolerability assessments collected at Visits 2 through 8."}

Methods

• Document: K1_Iver-C_RecruitmentInformedConsent (Recruitment arrangements) — title present in CTIS documents but no methods details extracted in record
• Document: K2_Iver-C_Recruitment material_Referral Letter — recruitment referral letter document title present
• Document: K2_Iver-C_Recruitment material_DesignPoster-Flyer — recruitment poster/flyer document title present
• Document: L2_Iver-C_PatientCard — patient card document title present

Germany

Earliest CTIS Part Ii Submission Date

23-10-2024

Latest Decision Or Authorization Date

11-04-2025

Processing Time Days

170

Number Of Sites

14

Number Of Participants

726

Primary sponsor

Full Name

Dermapharm AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

GKM Gesellschaft fuer Therapieforschung mbH

Responsibilities

sponsorDuties codes: 10,6,7

Name

Symbio Clinical Research GmbH

Responsibilities

sponsorDuties codes: 1,2

Third parties

• {"country":"Germany","full_name":"GKM Gesellschaft fuer Therapieforschung mbH","duties_or_roles":"sponsorDuties codes: 10,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Symbio Clinical Research GmbH","duties_or_roles":"sponsorDuties codes: 1,2","organisation_type":"Pharmaceutical company"}