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Study of N-Acetyl-GED-0507-34-LEVO 5% gel applied daily for 12 weeks in patients with acne vulgaris

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What is this trial about?

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

This study investigates a new treatment for acne vulgaris, a common skin condition that causes spots and pimples on the face and sometimes on the upper body. The study will test a new medication called N-Acetyl-GED-0507-34-Levo gel 5%, which is applied directly to the skin, comparing it with a vehicle gel (a gel without the active medication).

The purpose of this research is to determine how well this new gel works and how safe it is for treating acne when used once daily for 12 weeks. The treatment involves applying the gel to affected areas of the face, and if needed, to the upper chest, shoulders, and upper back areas that can be reached for self-application.

During the study, participants will use either the treatment gel or vehicle gel once daily for 12 weeks. Healthcare providers will monitor changes in acne by counting the number of different types of spots and evaluating the overall appearance of the skin. They will also check for any skin reactions or other effects that might occur during treatment. The study will track how the treatment affects participants' quality of life and overall well-being.

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 face will be examined to confirm acne vulgaris diagnosis and determine its severity

    If applicable, your trunk area (shoulders, upper back, and upper chest) will also be assessed if you have acne in these areas

    You will complete a quality of life questionnaire before the medical examination

  2. Step 2

    Treatment assignment

    You will receive either N-Acetyl-GED-0507-34-Levo gel 5% or a comparison gel

    The gel should be applied to affected areas once daily

    You will receive instructions on how to properly apply the medication

  3. Step 3

    Treatment period

    The treatment duration is 12 weeks

    You will need to apply the gel to affected areas of your face once daily

    If you have trunk acne, you will also apply the gel to reachable affected areas on your shoulders, upper back, and upper chest

  4. Step 4

    Follow-up visits

    Regular check-ups will be scheduled to monitor your progress

    Your skin will be examined for changes in acne lesions

    The doctor will check for any skin reactions at the application sites

    Your vital signs will be monitored

    You will report any side effects or discomfort experienced

  5. Step 5

    Final assessment

    After 12 weeks, a final examination will evaluate the treatment results

    The number and type of acne lesions will be counted

    You will complete another quality of life questionnaire

    The doctor will assess the overall condition of your skin and any side effects

Who can join the trial?

15 criteria

  • Patient must sign an informed consent form
  • Age must be between 9 and 49 years old
  • Must have facial acne with the following characteristics:
    • For patients over 14 years: moderate to severe acne (score 3-4 on doctor's assessment)
    • For patients 9-14 years: mild to severe acne (score 2 or higher on doctor's assessment)
    • Between 20 and 100 inflammatory spots (red, raised bumps or pus-filled spots)
    • Between 20 and 100 non-inflammatory spots (blackheads and whiteheads)
    • No more than 1 large, deep acne bump (nodule)
    • If having back or chest acne (optional):
      • Must have moderate acne on upper back, shoulders, or upper chest
      • Must be able to reach these areas to apply medication
      • Must have 20-100 inflammatory spots and 20-100 non-inflammatory spots
      • No more than 1 nodule in these areas
      • Must be able to understand the study requirements and potential risks
      • For patients under 18, parents or legal guardians must also understand and agree to study requirements
      • Women who can become pregnant must use effective birth control throughout the study:
        • If using hormonal birth control (pills, implants, patches, or injections), must be using it for at least 6 months before starting
        • If using non-hormonal IUD, must be in place at least 2 months before starting

Who cannot join the trial?

15 criteria

  • Age below 12 years or above 65 years
  • Pregnant women or women planning pregnancy during the study
  • Breastfeeding women
  • History of allergic reactions to similar skin medications
  • Current use of other acne treatments (medications applied to skin or taken orally)
  • Presence of severe skin conditions other than acne vulgaris
  • Recent participation in other clinical trials (within last 30 days)
  • Any serious medical conditions that could interfere with the study
  • Inability to follow study procedures or attend scheduled visits
  • Use of medications that may interfere with the study treatment
  • History of skin cancer or pre-cancerous lesions
  • Active skin infection in the areas to be treated
  • Plans for extensive sun exposure or tanning during the study period
  • History of poor response to similar acne treatments
  • Unwillingness to maintain consistent skincare routine during study period
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Investigated drugs

N-Acetyl-GED-0507-34-LEVO gel is a topical medication being tested for treating acne vulgaris (common acne). This gel is designed to be applied directly to the skin once daily. The medication is being studied to understand how well it works and how safe it is for people with acne. A vehicle gel (placebo) is also used in this trial as a comparison to evaluate the effectiveness of the active medication.

What is already known about the treatment

N-Acetyl-GED-0507-34-LEVO gel - A topical medication in gel form designed for once-daily application in the treatment of acne vulgaris. This investigational drug is currently undergoing Phase III clinical trials to evaluate its efficacy and safety compared to a vehicle gel placebo. The medication is applied directly to affected skin areas, though its specific molecular mechanism of action in treating acne requires further research and documentation. As a topical formulation with 5% concentration, it represents a new potential therapeutic option in dermatological treatment, specifically targeting common acne symptoms.

Investigated diseases

Acne Vulgaris – A common skin condition that occurs when hair follicles become clogged with oil and dead skin cells. It typically appears as different types of bumps on the skin, including whiteheads, blackheads, pimples, and cysts. The condition most commonly affects the face, chest, and back areas. Acne vulgaris usually begins during puberty due to increased hormone levels that stimulate oil production in the skin. The condition can persist into adulthood and may vary in severity from mild to severe, with some people experiencing inflammation and scarring. The appearance of acne lesions is influenced by several factors, including excess oil production, bacterial growth, and inflammation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510341-19-00Protocol codeNACGED0507ACN0123BEstimated enrolment390 patientsSponsorPPM Services S.A.

sourced from the EU Clinical Trials Register and site verification

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