Papulopustular rosacea Trials in Disease

Study on the Effectiveness and Safety of Ivermectin Cream Compared to a Drug Combination for Patients with Papulopustular Rosacea

This trial is being conducted in Germany and focuses on testing whether a new ivermectin cream can effectively treat the inflammatory lesions that appear with this condition. The study compares the new cream to Soolantra Cream, an existing ivermectin-based treatment, and to a cream without ivermectin to determine which works best.

Who can participate:

• Adults aged 18 years or older, both men and women
• People diagnosed with papulopustular rosacea according to standard medical criteria
• Participants must have between 15 and 50 inflammatory lesions (red or pus-filled bumps) on their face, with no more than 2 larger nodules
• The condition must be rated as moderate or severe by the study doctor
• Women who can become pregnant must use highly effective birth control throughout the study and have a negative pregnancy test before starting
• Participants must provide written consent after understanding the study requirements

Who cannot participate:

• People without a confirmed diagnosis of papulopustular rosacea
• Those outside the specified age range
• Individuals with other skin conditions that could interfere with study results
• People currently using other treatments that might affect the study outcomes
• Those with known allergies to the study medications or their ingredients
• People who have recently participated in another clinical trial
• Individuals with certain medical conditions that could affect their safety during the study

Focus and goal:

The main goal of this trial is to determine how effectively the creams reduce the number of inflammatory lesions on the face over a 12-week treatment period. Participants will apply one of the three creams once daily to affected areas of their face. Throughout the study, researchers will count the lesions and evaluate the severity of the condition using standardized scales. The trial will also monitor any side effects and assess how well participants tolerate the treatment. Regular follow-up visits are scheduled to track progress, measure changes in facial redness, and evaluate overall therapeutic success. At the end of the study, researchers will compare the percentage change in inflammatory lesions from the beginning to the end of treatment to determine which cream is most effective.

Investigational drugs:

The trial is testing Ivermectin Cream (10 mg/g), which is applied to the skin to reduce inflammatory lesions. While ivermectin is known as an antiparasitic medication, its exact mechanism in treating this condition is not fully understood. The study compares it to Soolantra Cream (10 mg/g), an existing approved treatment that also contains ivermectin, and to a cream without ivermectin (vehicle) to evaluate effectiveness and safety.