Double-blind, randomised clinical study comparing efficacy and safety of Ivermectin 10 mg/g Cream (Test) vs. Soolantra® 10 mg/g Cream (Reference) vs. Vehicle in patients with papulopustular rosacea

Conditions

Papulopustular Rosacea

Brief summary

Percent change from baseline (Visit 1) to Visit 8 (EoT) assessed by the inflammatory lesion (papules and pustules) count

Detailed description

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., 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., 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, Evaluation of tolerability by the investigator and by the patient from Visit 2 to Visit 8 (EOT)

Related papers

No related papers found yet.

Interventions

DRUGVehicle to Test Product

DRUGSoolantra 10 mg/g Creme

DRUGIvermectin Cream

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline (Visit 1) to Visit 8 (EoT) assessed by the inflammatory lesion (papules and pustules) count	—

Secondary

Measure	Time frame
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., 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., 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, Evaluation of tolerability by the investigator and by the patient from Visit 2 to Visit 8 (EOT)	—

Measure

Time frame

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., 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., 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, Evaluation of tolerability by the investigator and by the patient from Visit 2 to Visit 8 (EOT)

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Countries

Germany

Outcome results

None listed