Study Comparing Effects of Ointments with Clotrimazole and Betamethasone Dipropionate for Patients with Moderate to Severe Skin Yeast Infections

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What is this study about?

This clinical trial is focused on studying the effects of two ointments for treating candidiasis of the skin, which is a type of skin infection caused by yeast fungi. The study involves patients with moderate to severely inflamed skin due to this infection. The trial will compare the effectiveness and safety of a new ointment called Mecloderm, which contains the active substances clotrimazole and betamethasone dipropionate, against an existing ointment known as Lotricomb, which contains the same active substances. Additionally, a third ointment without any active substances, referred to as a vehicle, will also be used for comparison.

The purpose of the study is to assess how well these ointments work in reducing the symptoms of the infection and to ensure they are safe for use. Participants in the study will apply one of the ointments to their skin as directed. The study will last for a period of two weeks, during which the participants will be monitored to see how their symptoms change over time. The study will involve several visits to check the progress and gather information on the effectiveness of the treatment.

Throughout the study, the participants’ skin condition will be evaluated by both the study investigators and the participants themselves. The main goal is to determine which ointment is most effective in treating the infection and to ensure that it is safe for patients to use. The study will also look at whether the infection returns after treatment and how the participants feel about the treatment’s success.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of skin infection, and other health parameters.

Consent is required after receiving detailed information about the study.

2 initial assessment

An initial assessment is conducted to evaluate the severity of the skin condition. This includes a clinical examination and a swab test to confirm the presence of yeast fungi.

3 treatment phase

Participants are randomly assigned to one of three treatment groups: Mecloderm Ointment, Lotricomb Ointment, or a vehicle ointment without active substances.

The ointments are applied to the skin as directed, typically for a duration of 14 days.

Mecloderm Ointment contains clotrimazole (10 mg/g) and betamethasone dipropionate (0.64 mg/g).

4 follow-up visits

Follow-up visits are scheduled to monitor progress and assess the effectiveness of the treatment.

These visits include clinical evaluations and possibly additional swab tests to check for the presence of fungi.

5 end of treatment evaluation

At the end of the treatment period, a main examination is conducted to determine treatment success.

Success is defined by a reduction in clinical symptoms and a negative result for fungal presence.

6 final examination

A final examination is performed to evaluate the overall therapeutic success and to check for any signs of relapse or re-infection.

The results from this examination contribute to the overall assessment of the treatment’s efficacy and safety.

Who Can Join the Study?

Women and men who are 18 years or older can participate.
Participants must provide written consent after being fully informed about the study by a doctor or a qualified team member.
Participants must have a diagnosis of candidiasis of the skin, which is a type of skin infection, based on visible symptoms.
A positive test result from a skin swab must show at least a moderate number of fungi under a microscope.
The total score of all clinical symptoms like redness, fluid discharge, burning sensation, and skin softening must be 7 or higher.
The severity of redness and fluid discharge must be at least moderate, meaning a score of 2 or higher.
Women who can have children must use a highly effective birth control method throughout the study.
Women who can have children must have a negative pregnancy test before starting the study.

Who Cannot Join the Study?

Patients who are allergic to any of the ingredients in the ointment cannot participate. An allergy is when your body reacts badly to something that is usually harmless.
Patients with other skin infections that are not caused by the fungus Candida cannot participate. Candida is a type of fungus that can cause infections.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who have used similar treatments recently may not be eligible. This is to make sure the study results are accurate.
Patients with certain medical conditions that might interfere with the study cannot participate. This is to ensure the safety of the patient and the accuracy of the study.
Patients who are unable to follow the study instructions or attend the required visits cannot participate. This is important for the study to be conducted properly.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Hautarztpraxis Dr. Leitz Und Kollegen	Stuttgart	Germany
ZENTderma	Moenchengladbach	Germany
Gemeinschaftspraxis Drs. Grosskopf	Wallerfing	Germany
Frauenarzt-Praxis Erwin Göckeler-Leopold	Geseke	Germany
Skin Care Center	Hamm	Germany
Hclsaxcnmzpebt Dsq Pvrfnux	Crimmitschau	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	28.04.2022

Trial locations

Investigated drugs:

Mecloderm® Ointment is a new ointment being tested for its effectiveness and safety in treating skin inflammation caused by candidiasis. It contains two active ingredients: clotrimazole, which helps fight fungal infections, and betamethasone dipropionate, which reduces inflammation and itching.

Lotricomb® Ointment is an existing medication used as a reference in the study. It is also used to treat skin inflammation and infections. Like Mecloderm®, it contains clotrimazole to combat fungal infections and betamethasone dipropionate to alleviate inflammation and itching.

Candidiasis of the Skin – Candidiasis of the skin is a fungal infection caused by the overgrowth of Candida species, commonly Candida albicans. It typically affects warm, moist areas of the body, such as the armpits, groin, and under the breasts. The condition is characterized by red, inflamed patches that may be itchy or painful. In moderate to severe cases, the skin may become cracked or develop blisters. The infection can spread to other areas if not managed properly. It is more common in individuals with weakened immune systems or those with certain medical conditions.

Trial ID:

2022-501415-14-00

Protocol code:

21-01/ClotriBet-S

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Effects of Ointments with Clotrimazole and Betamethasone Dipropionate for Patients with Moderate to Severe Skin Yeast Infections

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?