ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars
Do you have indented acne scars that bother you? This study is testing a new injectable gel called ELAPR002f. These scars, which can appear after acne clears, can make people feel self-conscious. ELAPR002f is designed to immediately fill in these scar tissues. The study wants to find out how safe and effective this gel is for adults with moderate to severe acne scars on their face. Participants will receive either the ELAPR002f gel or a harmless saline solution. Researchers will follow their progress for just over a year to see the results. Taking part means regular clinic visits and various health checks.
At a glance
What is this study about?
Acne is a common skin condition, and for some people, it can leave behind scars. These scars, known as "atrophic acne scars," often look like small indentations or depressions in the skin. They can be a source of frustration and affect how people feel about themselves, sometimes leading to reduced self-confidence.
This study, called ELAPR002f, is exploring a new treatment option for these types of scars: an injectable gel. This gel is designed to provide an immediate "filling" effect, hopefully making the scars less noticeable. The main goal of the study is to carefully check if this new gel is both safe to use and effective in improving the appearance of atrophic acne scars in adults.
Approximately 156 adults with moderate to severe acne scarring on both cheeks will be invited to participate. They will be split into two groups by chance: one group will receive the ELAPR002f gel, and the other will receive a saline solution (which acts as a comparison). This allows researchers to properly compare the effects of the new treatment. The study will take place in clinics in Germany and Canada.
Key takeaways
- Tests a new injectable gel (ELAPR002f) for indented acne scars.
- Aims to check both safety and how well the gel works.
- Participants will receive 3 treatments over 2 months, followed by 12 months of observation.
- Includes a comparison group receiving a saline solution (1 in 4 chance).
- Requires regular clinic visits and health checks.
- Specifically targets moderate to severe indented acne scars on the cheeks.
Who may be eligible?
To join this study, you need to be an adult at least 18 years old and generally in good health, without an active COVID-19 infection. The study is specifically for people who are looking to improve the appearance of their indented acne scars, and these scars must be classed as moderate to severe on both cheeks by the study doctors.
Your scars need to be mostly the "rolling" or "boxcar" type, and you should have at least five of these types of scars on each cheek. It’s also important that the skin around these specific scars is otherwise healthy.
However, there are reasons you might not be able to join. For instance, if you have active acne on your face, other skin infections like herpes, or conditions like rosacea or unhealed wounds. The study isn't suitable if your scars are mainly "ice pick" type, or if you have a history of developing thick, raised scars (keloids), or certain autoimmune diseases like rheumatoid arthritis or lupus. If you have severe vision issues or certain lung diseases, or if you're allergic to any ingredients in the gel, you also wouldn't be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have moderate to severe indented acne scars on both cheeks?
- Are you generally healthy, without active COVID-19 or other significant skin infections?
- Do you *not* typically develop thick, raised scars (keloids)?
- Are you *not* currently suffering from active facial acne, rosacea, or unhealed wounds?
- Do you *not* have specific autoimmune diseases or severe vision problems?
What does participation involve?
If you decide to take part in this study, you will be assigned by chance to one of two groups: either you'll receive the ELAPR002f injectable gel, or a saline solution, which acts as a comparison. There's a 1 in 4 chance you'll be in the saline group. You will receive three separate injections over a period of two months. These injections will be given directly into the skin of your scars.
After your treatments, you'll be followed up for about 12 additional months. During this time, you'll need to attend regular appointments at a hospital or clinic. These visits will involve various checks, including medical assessments by the study team, blood tests, and careful monitoring for any side effects. You'll also be asked to complete questionnaires about your experience and how you feel about your scars. This study might involve more appointments and tests than your usual care for acne scars.
Potential risks and benefits
Locations (12)
- Alberta DermaSurgery Centre /ID# 243168Verified postcodeEdmonton, Canada
- Humphrey & Beleznay Cosmetic Dermatology /ID# 266634Verified postcodeVancouver, Canada
- Pacific Derm /ID# 227467Verified postcodeVancouver, Canada
- Dermetics Cosmetic Dermatology /ID# 227469Verified postcodeBurlington, Canada
- The Centre For Clinical Trials /ID# 233841Verified postcodeOakville, Canada
- The Center For Dermatology /ID# 227470Verified postcodeRichmond Hill, Canada
- Bertucci MedSpa Inc. /ID# 227468Verified postcodeWoodbridge, Canada
- Hautok and Hautok-cosmetics /ID# 227474Verified postcodeMunich, Germany
- Dermatologie Mahlow /ID# 262566Verified postcodeBlankenfelde-Mahlow, Germany
- Rosenpark Research /ID# 227471Verified postcodeDarmstadt, Germany
- MVZ Corius MediCorium GmbH /ID# 227475Verified postcodeFriedrichsdorf, Germany
- Privatpraxis Dr. Hilton & Partner /ID# 227472Verified postcodeDüsseldorf, Germany
Common questions
What kind of scars is this study for?
This study is for 'atrophic acne scars', which are usually indented or sunken marks left after acne clears up.
Will I definitely get the new gel treatment?
No, you have a 1 in 4 chance of receiving a saline solution (a salt water injection) instead of the new gel. This helps researchers compare results fairly.
How long does the study last?
You'll have three treatments over two months, and then you'll be followed up for about 12 more months, so roughly 14 months in total.
What does 'investigational device' mean?
It means the ELAPR002f gel is still being tested and hasn't been approved for widespread use yet. This study is part of that testing process.
Where does the study take place?
The study is taking place in specific clinics across Germany and Canada.
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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