A multicenter, randomized, double-blind, parallel, three-arm, active- and placebo-controlled therapeutic equivalence study for the comparison of clindamycin + tretinoin/Verisfield gel (1+0.025)% with Acnatac®/Meda gel [clindamycin + tretinoin (1+0.025)%] in the treatment of acne vulgaris.
This research study is looking at a new gel for treating acne. It's designed to see how it compares to a well-known acne treatment called Acnatac®. Both gels contain the same two main ingredients: clindamycin and tretinoin, which are medicines used to clear up spots. The main goal is to find out if the new Verisfield gel works just as effectively and safely as Acnatac®. The study will involve groups of people using one of the gels, or a dummy gel (placebo), for 12 weeks. Researchers will count different types of spots (inflamed and non-inflamed) before and after treatment to see how much they improve.
At a glance
What is this study about?
This clinical trial is designed to investigate a new gel treatment for acne. Acne is a very common skin condition that causes spots, oily skin, and sometimes skin that's hot or painful to touch. The new gel, made by a company called Verisfield, contains two active ingredients: clindamycin and tretinoin. Clindamycin is an antibiotic that helps to kill bacteria contributing to acne and reduces redness, while tretinoin is a retinoid that helps to unblock pores and improve skin cell turnover.
The study aims to compare this new Verisfield gel with an existing and widely used acne treatment called Acnatac®, which contains the same two ingredients at the same strengths. This type of study, often called a 'therapeutic equivalence' study, means the researchers want to confirm that the new gel works just as well as the established treatment. They will also compare both active gels to a 'placebo' gel, which looks the same but contains no active medicine, to ensure any improvements seen are due to the actual medication.
Over 12 weeks, participants will use one of the gels, and researchers will carefully track what happens to their acne. They will be looking at how much the number of spots reduces, including both red, swollen spots (papules and pustules) and non-inflamed spots like blackheads and whiteheads (comedones). They will also check for any side effects and how well people tolerate the gels. This information is crucial for determining if the new Verisfield gel can be a good option for people with acne.
Key takeaways
- Compares a new acne gel to an existing one.
- Both gels contain clindamycin and tretinoin.
- Study lasts for 12 weeks.
- Measures changes in spot counts (inflamed and non-inflamed).
- Looks for side effects and how well treatments are tolerated.
- Participants are adults, aged 18 and over.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old. Both men and women are welcome to take part.
Before you can join, the researchers will need to check some other things to make sure the study is right for you and that you meet all the specific health requirements. These usually involve your general health and your specific acne condition.
It's important that you don't have any medical conditions or aren't taking any other medicines that could interfere with the study treatments or put your health at risk. The study staff will explain all of these details to you.
- Are you at least 18 years old?
- Do you have acne vulgaris?
- Are you able to attend regular clinic visits for 12 weeks?
- Are you generally healthy enough for a clinical study?
- Are you not using other acne medications that might interfere?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be assigned to one of three groups: one group will use the new Verisfield gel, another will use the existing Acnatac® gel, and a third group will use a 'dummy' gel (placebo). You won't know which gel group you're in, and neither will your study doctor, which helps to keep the results fair.
The study will last for 12 weeks. During this time, you'll apply the assigned gel to your face as instructed. You'll have several visits to the clinic where the study team will: count your spots (both inflammatory and non-inflammatory), check your skin for any reactions (like redness, dryness, or stinging), and ask you about any side effects you might be experiencing. These visits will help the researchers track how your acne is improving and how you are tolerating the treatment.
Potential risks and benefits
Locations (1)
- —Greece
Common questions
What kind of acne does this study look at?
This study is for 'acne vulgaris', which is the most common type of acne, causing spots, blackheads, and whiteheads.
Will I know which treatment I'm getting?
No, you won't know if you're getting the new gel, the existing gel, or the dummy gel. This is called 'double-blind' and helps ensure fair results.
How long will the treatment last?
The treatment part of the study will last for 12 weeks.
What are the main ingredients in the gels?
The main ingredients are clindamycin, an antibiotic, and tretinoin, which helps clear pores and skin turnover.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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