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Title: Long-term safety study of N-Acetyl-GED-0507-34-LEVO gel 5% applied to the skin for patients with acne vulgaris

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study examines the long-term safety and effectiveness of a new topical medication for acne vulgaris, a common skin condition that causes pimples, blackheads, and whiteheads on the face and body. The medication being tested is N-Acetyl-GED-0507-34-Levo gel 5%, which is applied to the skin once daily.

The study aims to determine how safe and effective this gel treatment is when used for up to 52 weeks (one year) in people with acne. The medication will be applied to affected areas on the face, and in some cases, it may also be used on the upper chest, shoulders, and upper back areas where acne is present.

During the study, participants will have regular check-ups where doctors will monitor their skin's response to the treatment. They will assess changes in acne severity, count the number of acne lesions, and keep track of any side effects. The study will also evaluate how the treatment affects participants' quality of life. Throughout the study, doctors will monitor participants' overall health through physical examinations and laboratory tests.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and assessment

    Your skin condition (acne vulgaris) will be evaluated on your face and, if applicable, on your upper body (shoulders, upper back, and chest).

    The doctor will perform a physical examination and collect basic health information.

    Laboratory tests will be conducted to establish baseline values.

  2. Step 2

    Treatment period begins

    You will receive N-Acetyl-GED-0507-34-Levo gel 5% for daily application.

    The gel needs to be applied once per day to the affected areas.

    The treatment will continue for up to 52 weeks (one year).

  3. Step 3

    Follow-up visits

    Regular check-ups will occur at weeks 12, 26, 38, and 52.

    During these visits, the doctor will evaluate:

    - Changes in your skin condition

    - Any skin reactions at the application site (redness, peeling, dryness, stinging, burning, or itching)

    - Your overall health through physical examinations and laboratory tests

    You will complete a quality of life questionnaire at the beginning, week 12, and week 52 of the study.

  4. Step 4

    Safety monitoring

    Throughout the study, any side effects or health changes will be recorded.

    The doctor will monitor your vital signs and overall health at each visit.

    If you experience any concerning symptoms, they should be reported to the study doctor.

  5. Step 5

    Final evaluation

    At week 52, a final comprehensive assessment will be conducted.

    This includes evaluation of your skin condition, final laboratory tests, and completion of the quality of life questionnaire.

    The doctor will perform a final physical examination and review of your overall health status.

Who can join the trial?

13 criteria

  • Must sign an informed consent document before participating in the study
  • Age requirements:
    • Must be at least 9 years old
    • Must be under 50 years old
    • Must have facial acne with specific severity levels:
      • For new patients: mild to moderate acne severity (IGA score of 1 or 2)
      • For continuing patients: any severity level (IGA score of 0 or higher)
      • May have body acne (optional) on:
        • Shoulders
        • Upper back
        • Upper chest
        • Must be able to understand and follow study requirements:
          • Patients under 18 must have parent or legal guardian approval
          • Must be able to cooperate with study staff
          • Must be able to follow study procedures
          • Women who can become pregnant must use effective birth control:
            • Hormonal contraceptives (pills, implants, patches, or injections) for at least 6 months before screening
            • Non-hormonal IUD for at least 2 months before screening

Who cannot join the trial?

13 criteria

  • Age below 12 years or above 65 years
  • Pregnancy or breastfeeding
  • Known allergic reactions to topical acne medications
  • Severe or cystic acne requiring oral medication
  • Current use of other acne treatments (must be discontinued before participation)
  • Presence of skin conditions other than acne that might interfere with the study evaluations
  • History of skin cancer or precancerous lesions in the treatment area
  • Participation in another clinical trial within the past 30 days
  • Medical conditions that might affect the study results, including:
    • Uncontrolled endocrine disorders (hormone-related conditions)
    • Severe immunosuppression (weakened immune system)
    • Active skin infections
    • Unable to follow study procedures or attend regular follow-up visits for 52 weeks
    • History of poor compliance with medical treatments
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Investigated drugs

N-Acetyl-GED-0507-34-LEVO gel is a topical medication being studied for treating acne vulgaris (common acne). It is applied directly to the skin once daily. This investigational treatment is being evaluated for long-term use to determine if it is safe and effective for people with acne. The gel formulation is designed to be easy to apply and absorb into the skin where acne occurs.

What is already known about the treatment

N-Acetyl-GED-0507-34-LEVO gel - A topical medication in gel form applied once daily for the treatment of acne vulgaris (common acne). This investigational drug is currently undergoing clinical trials to evaluate its long-term safety and effectiveness over a 52-week treatment period. The gel formulation is designed for direct application to affected skin areas, though its precise molecular mechanism of action in treating acne is still being studied through clinical research. As an experimental therapeutic agent, it belongs to the category of topical acne treatments and is being evaluated as a potential new option for managing acne vulgaris symptoms.

Investigated diseases

Acne vulgaris - A common skin condition that occurs when hair follicles become clogged with oil and dead skin cells. The condition typically appears as different types of bumps on the skin, including whiteheads, blackheads, pimples, and deeper lumps. It most commonly affects areas of the skin with a high number of oil glands, such as the face, chest, and back. The condition usually begins during puberty when hormonal changes increase the skin's oil production. Acne lesions develop when the combination of excess oil and dead skin cells creates an environment where bacteria can thrive within the follicles. The resulting inflammation leads to the characteristic redness and swelling associated with acne breakouts.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510342-24-00Protocol codeNACGED0507ACN0123LTEstimated enrolment826 patientsSponsorPPM Services S.A.

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