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Study Comparing Isotretinoin with Doxycycline, Tretinoin, and Adapalene for Moderate Acne in Patients with Skin of Color

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of acne, a common skin condition that causes pimples and spots, particularly on the face. The study will compare the effectiveness of an oral medication called isotretinoin with other standard treatments currently used for moderate acne in individuals with skin of color. The goal is to determine if starting treatment with isotretinoin earlier can better reduce the severity of acne-related skin changes over a six-month period.

Participants in the study will receive either isotretinoin or one of the standard treatments, which may include medications like doxycycline, tretinoin cream, adapalene cream, or lymecycline. The study will last for up to six months, during which time participants will be asked to take selfies of their facial skin to monitor changes. These images will be analyzed using a special algorithm designed to assess the severity of acne and any related skin pigmentation issues.

The study will also look at other factors, such as the number and type of acne lesions, any side effects experienced, and the overall quality of life of participants. This information will help researchers understand the benefits and risks of using isotretinoin compared to other treatments for moderate acne in people with darker skin tones. The trial aims to provide valuable insights into the most effective ways to manage acne and improve skin health in this population.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, skin type, and acne severity.
Informed consent is required, and participants must have a cell phone capable of taking high-quality selfies.
Step 2
Initial assessment
An initial assessment of acne severity is conducted using facial pictures.
The severity is measured by a dedicated algorithm, with scores ranging from 0 (no acne) to 4 (severe acne).
Step 3
Medication administration
Participants receive either oral isotretinoin or standard care treatments.
Standard care may include medications such as doxycycline (100 mg tablets), tretinoin cream, adapalene cream, or lymecycline (408 mg capsules).
The specific dosage and frequency depend on the assigned treatment group.
Step 4
Follow-up assessments
Follow-up assessments occur at 3 months and 6 months.
Facial pictures are taken to evaluate the evolution of acne lesions using the same algorithm.
The severity of acne and any side effects are monitored.
Step 5
Final evaluation
At 6 months, a final evaluation is conducted to assess the effectiveness of the treatment.
Success is defined as achieving an acne severity score of less than 2, indicating no or very mild acne.
Step 6
Quality of life assessment
Throughout the study, quality of life is evaluated using the Acne-specific Quality of Life questionnaire.
This assessment helps understand the impact of acne and its treatment on daily life.

Who can join the trial?

6 criteria

Women and men between the ages of 13 and 30.
Individuals with skin types IV, V, and VI. These are darker skin tones according to a scale called the Fitzpatrick skin types.
Have **moderate acne**. This means acne that is not too mild or too severe, as defined by specific guidelines from the French Society of Dermatology.
Must have a cell phone that can take selfie pictures with a minimum quality of 5 megabytes.
Must sign an **informed consent**. This is a document that explains the study and confirms that you agree to participate.
Must be affiliated with French social coverage, which means having access to the French healthcare system.

Who cannot join the trial?

10 criteria

Patients who are pregnant or planning to become pregnant during the study.
Patients who are breastfeeding.
Patients with a known allergy to isotretinoin or any of its ingredients.
Patients with severe liver disease. The liver is an organ that helps process food and remove waste from the body.
Patients with high levels of cholesterol or triglycerides. These are types of fats found in the blood.
Patients taking certain medications that may interact with isotretinoin. Interact means the medications may affect each other’s effectiveness or cause side effects.
Patients with a history of depression or other mental health issues. Depression is a condition that affects mood and feelings.
Patients with a history of inflammatory bowel disease. This is a condition that causes inflammation in the digestive tract.
Patients who have not used effective birth control methods if they are of childbearing potential. Birth control methods help prevent pregnancy.
Patients who have participated in another clinical trial within the last 30 days.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHU De Martinique
Verified
Fort De France, France
Centre Hospitalier Universitaire De Bordeaux
Verified
Bordeaux, France
Centre Hospitalier Universitaire De Nantes
Verified
Nantes, France

Trial locations

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Investigated drugs

Isotretinoin
is a medication used in this trial to treat moderate acne in patients with skin of color. It is taken orally and works by reducing the amount of oil released by the skin's oil glands, helping the skin renew itself more quickly. This medication is being tested to see if it is more effective than the current standard treatments for acne.
Standard of Care
refers to the usual treatments that are currently used to manage moderate acne. These treatments can include topical creams, gels, or oral medications that help reduce acne symptoms. The trial aims to compare these standard treatments with isotretinoin to determine which is more effective for patients with skin of color.

What is already known about the treatment

Isotretinoin – Isotretinoin is administered orally in the form of capsules. It is currently well-established in medical literature as an effective treatment for severe acne, particularly in cases that do not respond to other treatments. The main therapeutic indication for isotretinoin is the treatment of moderate to severe acne. At the molecular level, isotretinoin works by reducing the size and output of sebaceous glands, decreasing the amount of oil produced in the skin, and preventing the clogging of pores. It is classified pharmacologically as a retinoid, which is a derivative of vitamin A.

Investigated diseases

Acne – Acne is a common skin condition that occurs when hair follicles become clogged with oil and dead skin cells. It often appears on the face, neck, chest, back, and shoulders. The condition is characterized by the presence of pimples, blackheads, whiteheads, and sometimes cysts or nodules. Acne can vary in severity, ranging from mild to severe, and may cause inflammation and redness. It is most prevalent during adolescence but can affect individuals of all ages. Over time, acne can lead to scarring and changes in skin pigmentation if not managed properly.