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RecruitingPHASE3INTERVENTIONAL

Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients

This study, called a clinical trial, aims to find the best way to treat moderate acne in people with darker skin tones (Fitzpatrick skin types IV-VI). Acne can cause dark spots, which can affect how people feel about themselves. Currently, treatments often start with antibiotics, but these haven't been specifically tested for dark spots. This trial will compare oral isotretinoin, a strong acne medication, with standard treatments like antibiotics and creams. Researchers want to see if isotretinoin is better at reducing these dark spots and controlling acne from the start. We are looking for 420 participants aged 13-30.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Centre Hospitalier Universitaire de Nice
Enrolment target
420
Start
29 Apr 2025
Estimated completion
01 Sep 2027

What is this study about?

Acne is a common skin condition that can affect anyone. For some people, especially those with darker skin tones, acne can leave behind dark spots or marks on the skin called post-inflammatory hyperpigmentation. These spots can be very bothersome and impact how people feel about their appearance and their overall well-being. Currently, standard treatments for moderate acne often involve antibiotics taken by mouth or various creams. However, these treatments weren't always developed with darker skin types in mind, and their effectiveness in reducing these specific dark spots isn't always clear.

This study, called a Phase 3 clinical trial, is designed to compare a medication called isotretinoin, which is taken by mouth, with the usual treatments for moderate acne in people with darker skin tones. Isotretinoin is known to be very effective for acne because it works on the oil glands in the skin. However, it's usually only prescribed if other treatments haven't worked well. This trial wants to see if using isotretinoin earlier might be a better approach for people with moderate acne and darker skin, particularly in helping to prevent or reduce those dark spots.

The main goal of this trial is to find out if starting treatment with oral isotretinoin is more effective at reducing dark spots caused by acne after six months, compared to the standard treatments we currently use. It's an important study because it could help doctors understand how to best treat acne in a way that addresses the specific concerns of people with darker skin, leading to better outcomes and improved quality of life.

Key takeaways

  • This study compares oral isotretinoin to standard acne treatments in people with darker skin.
  • The main goal is to see if isotretinoin is better at reducing dark spots (ARP) from acne.
  • It's for people aged 13-30 with moderate acne and Fitzpatrick skin types IV, V, or VI.
  • Participants will have regular check-ups, blood tests, and take photos of their skin.
  • This research aims to improve acne treatment specifically for people with darker skin tones.

Who may be eligible?

To be part of this study, you would generally need to be a man or woman between the ages of 13 and 30. Your skin type should be darker, specifically Fitzpatrick skin types IV, V, or VI. You would also need to have moderate acne as defined by specific medical guidelines.

There are also some other requirements, like having a smartphone that can take good quality selfie pictures. You'll need to agree to take part by signing a consent form and be covered by French social security.

You wouldn't be able to join if you have very mild or very severe acne, or if you've recently taken oral isotretinoin or certain antibiotics for acne. Also, if you're pregnant, breastfeeding, or unwilling to use effective contraception (if you're a woman who could become pregnant), you wouldn't be eligible. People with certain health conditions or allergies to the study medications would also not be able to participate.

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.

  1. Are you between 13 and 30 years old?
  2. Do you have moderate acne?
  3. Do you have a darker skin tone (Fitzpatrick IV, V, or VI)?
  4. Do you have a smartphone that can take clear photos?
  5. Are you not currently pregnant or breastfeeding?
  6. Have you not recently used isotretinoin or certain antibiotics for acne?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to either receive oral isotretinoin or standard acne treatment (which could include oral antibiotics like doxycycline or lymecycline, or a topical cream like tretinoin). You will have regular visits with the study team. They will assess your acne, take pictures of your skin (using your smartphone), and monitor your health with blood tests to check your blood count, liver function, and cholesterol levels. Women who can become pregnant will also have pregnancy tests. The visits and assessments will happen over approximately six months. You will be told exactly when to take your medication and how to use any creams. The overall duration of your active participation in the trial will be for six months, followed by any necessary follow-up.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving expert medical care and access to treatments that might be more effective for your condition. However, there are also potential risks associated with any medication, including side effects from isotretinoin (such as dry skin, lips, and eyes, and more serious risks if pregnant) or standard treatments. The study team will explain all known side effects in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (19)

  • CHU de Nice - Hôpital de l'Archet
    Verified postcode
    Nice, France· Recruiting
  • CHU de Bordeaux
    Verified postcode
    Bordeaux, France· Recruiting
  • CHU de Nantes
    Verified postcode
    Nantes, France· Recruiting
  • chu de Rouen
    Verified postcode
    Rouen, France· Recruiting
  • Cabinet de dermatologie St Maxime
    Verified postcode
    Sainte-Maxime, France· Recruiting
  • CH D'argenteuil
    Verified postcode
    Argenteuil, France· Recruiting
  • Cabinet Dermatologique Brest 1
    Verified postcode
    Brest, France· Recruiting
  • Cabinet Dermatologique Brest 2
    Verified postcode
    Brest, France· Recruiting
  • Cabinet dermatologique Cenon
    Verified postcode
    Cenon, France· Not yet recruiting
  • Cabinet dermatologique gradignan
    Verified postcode
    Gradignan, France· Recruiting
  • CHU de la réunion
    Verified postcode
    La Réunion, France· Recruiting
  • Ambroise paré
    Verified postcode
    Paris, France· Recruiting

Common questions

What is 'moderate acne'?

Moderate acne means your acne is not very mild or very severe, and typically includes several spots like blackheads, whiteheads, red bumps, and pus-filled pimples. The study uses specific medical guidelines to define this.

What are Fitzpatrick skin types IV, V, and VI?

These are categories used to describe how your skin reacts to the sun. Types IV, V, and VI represent darker skin tones that tan easily and rarely burn, and are more prone to developing dark spots after injury or inflammation, like acne.

What are 'acne-related pigmentation' (ARP)?

ARP refers to the dark spots or discolouration that can be left on your skin after acne spots have healed. These are often brown or black marks.

Will I know which treatment I'm getting?

Yes, this is an 'open study', which means both you and the study team will know whether you are receiving oral isotretinoin or the standard treatment.

Do I have to live in France to participate?

Yes, one of the requirements is to have coverage under the French social security system, which suggests the study is primarily recruiting participants in France.

How to find out more

Thierry Passeron, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Clinical Trial to Compare Oral Isotretinoin to Standard of C…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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