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

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What is this study about?

This clinical trial is focused on studying a skin condition called papulopustular rosacea, which is characterized by redness and bumps on the face. The study will test the effectiveness and safety of a new cream containing ivermectin, a medication used to treat various skin conditions. The trial will compare this new cream to an existing product called Soolantra Cream, which also contains ivermectin, and a cream without ivermectin, referred to as a vehicle.

The purpose of the study is to see how well these creams reduce the number of inflammatory lesions, such as papules and pustules, on the face. Participants will apply one of the creams to their skin over a period of 12 weeks. During this time, the study will monitor changes in the skin condition, including the number of lesions and any side effects experienced by the participants. The study aims to determine which cream is most effective in improving the symptoms of papulopustular rosacea.

Throughout the study, participants will have regular visits to assess their skin condition and overall health. The study will also evaluate the overall success of the treatment and how well participants tolerate the creams. This research will help to better understand the treatment options for papulopustular rosacea and provide valuable information on the safety and effectiveness of the new ivermectin cream compared to existing treatments.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of papulopustular rosacea, and the number of inflammatory lesions on the face.

Female participants of childbearing potential must use a highly effective contraceptive method and have a negative pregnancy test before starting the study.

2 initial visit and baseline assessment

During the initial visit, a baseline assessment is conducted. This includes counting the number of inflammatory lesions, such as papules and pustules, on the face.

The severity of rosacea is evaluated using the Investigator’s Global Assessment (IGA) scale.

3 treatment phase

Participants are randomly assigned to receive one of three treatments: Ivermectin 10 mg/g cream, Soolantra® 10 mg/g cream, or a cream without ivermectin (vehicle).

The cream is applied to the affected areas of the face once daily for a duration of 84 days, with a possible variation of plus or minus 4 days.

4 follow-up visits

Follow-up visits are scheduled at regular intervals to monitor progress and assess changes in the number of inflammatory lesions.

The severity of rosacea and any changes in facial redness are evaluated at each visit.

5 final evaluation

At the end of the treatment period, a final evaluation is conducted to assess the overall therapeutic success.

The primary measure of success is the percentage change in the number of inflammatory lesions from the start to the end of the study.

6 safety and tolerability assessment

Throughout the study, any adverse events are recorded to evaluate the safety of the treatments.

Both the investigator and the participant assess the tolerability of the treatment from the second visit until the end of the study.

Who Can Join the Study?

Women and men who are 18 years of age or older.
Must provide written consent to participate in the study after being informed by the study doctor.
Must have a diagnosis of papulopustular rosacea, which is a skin condition with redness and bumps on the face, according to commonly accepted standards.
Must have 15 to 50 inflammatory lesions on the face, which are red bumps or pus-filled bumps, and no more than 2 of these can be larger bumps called nodules.
Must have a rosacea severity grade of 3 (moderate) or 4 (severe) as assessed by the study doctor.
For all women who can have children: Must use a highly effective birth control method throughout the study.
For all women who can have children: Must have a negative urine pregnancy test before starting the study. The test must be sensitive enough to detect a hormone called human chorionic gonadotrophin (hCG) at levels as low as 25 mIU/ml.

Who Cannot Join the Study?

Individuals who are not diagnosed with Papulopustular Rosacea cannot participate. This is a skin condition that causes redness and bumps on the face.
Participants must be within the specified age range for the study.
Both males and females are eligible, but certain criteria may exclude some individuals.
People who are part of a vulnerable population may not be eligible. This can include groups like children, pregnant women, or those with certain health conditions.
Participants must not have any other skin conditions that could interfere with the study results.
Individuals who are currently using other treatments for rosacea that might affect the study outcomes are not eligible.
Participants should not have any known allergies to the study medications or their ingredients.
People who have participated in another clinical trial recently may be excluded.
Individuals with certain medical conditions that could affect the study or their safety may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Praxis Dr. med. Abdou Zarzour	Halle (Saale)	Germany
Gemeinschaftspraxis Drs. Josef und Wilma Großkopf	Wallerfing	Germany
Studienzentrum Dr. Beate Schwarz	Langenau	Germany

Other Sites

Site Name	City	Country
ProDerma	Duelmen	Germany
Mwbibbknnsl Cwfqfsl Fff Mcfuwdn Sdiygkq &iedy Soswifms Gwul	Magdeburg	Germany
Hhqkrklglhmciy Kili	Vechta	Germany
Dkyxj Sdpdcpa Ghpc	Hamburg	Germany
Hzdprlovjhnpug Dlx Ozanod uvs Dph Aymytlj	Ibbenbüren	Germany
Hexcgypizdvtud	Kiel	Germany
Hepwwozvbjyrol Deh Pcrwzvw	Crimmitschau	Germany
Htxh Hkagk ufp Ljwfqturlgmo Pjcuzvp	Potsdam	Germany
Gwbmoxhhfigretsnqnq Wmhyfcvleawjc	Augsburg	Germany
Pzvips Ddc Jrqej Rkryxny	Berlin	Germany
Hsaxybypkxmheya	Hamm	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	02.09.2024

Trial locations

Investigated drugs:

Ivermectin

Ivermectin Cream is being tested in this study to see how well it works in treating papulopustular rosacea, a skin condition that causes redness and bumps on the face. The cream is applied to the skin and is being compared to another treatment to see if it can reduce the number of inflammatory lesions.

Soolantra® Cream is the reference treatment in this study. It is also used to treat papulopustular rosacea by reducing inflammation and the number of lesions on the skin. The study aims to compare its effectiveness and safety against the test cream.

Investigated diseases:

Papulopustular rosacea

Papulopustular Rosacea – Papulopustular rosacea is a chronic skin condition characterized by redness, swelling, and acne-like breakouts. It primarily affects the central part of the face, including the cheeks, nose, and forehead. The condition progresses with the appearance of small, red, pus-filled bumps called papules and pustules. These lesions can cause discomfort and may be accompanied by a burning or stinging sensation. Over time, the skin may become thickened and develop a rough texture. The condition can fluctuate, with periods of flare-ups and remission.

Trial ID:

2023-505897-13-00

Protocol code:

23-03/Iver-C

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?