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Study of N-Acetyl-GED-0507-34-LEVO gel 5% applied daily for treating acne vulgaris

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What is this trial about?

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

This clinical trial studies the effectiveness and safety of a new topical medication for treating acne vulgaris, a common skin condition that causes pimples, blackheads, and whiteheads on the face and body. The study tests N-Acetyl-GED-0507-34-Levo gel 5%, which is applied to the skin once daily, comparing it to a placebo gel over a period of 12 weeks.

The study focuses on treating acne on both the face and trunk (upper chest, shoulders, and upper back) areas. The medication is being tested to see how well it reduces different types of acne lesions, including inflammatory lesions (red, swollen bumps) and non-inflammatory lesions (blackheads and whiteheads). The study will measure changes in the number of acne lesions and overall improvement in skin appearance.

Throughout the study, participants will have their acne assessed using standardized scoring systems. The research team will monitor the skin's response to treatment and any potential side effects. The study also includes evaluations of how acne affects quality of life using special questionnaires. Safety monitoring includes checking for skin reactions at the application site, such as redness, peeling, dryness, stinging, burning, or itching.

The research process

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

  1. Step 1

    Initial evaluation

    Your participation begins with an assessment of your facial acne vulgaris condition

    The doctor will evaluate the number of inflammatory lesions (papules and pustules) and non-inflammatory lesions (comedones) on your face

    If applicable, trunk acne (shoulders, upper back, and upper chest) will also be evaluated

  2. Step 2

    Treatment assignment

    You will receive either N-Acetyl-GED-0507-34-Levo gel 5% or a vehicle gel (gel without active ingredient)

    The gel needs to be applied once daily to affected areas

    The treatment period lasts for 12 weeks

  3. Step 3

    Regular assessments

    Your acne condition will be monitored throughout the 12-week period

    The doctor will evaluate changes in the number and type of acne lesions

    Physical examinations and vital signs checks will be performed during visits

    Laboratory tests will be conducted at the beginning and end of treatment

  4. Step 4

    Quality of life assessment

    You will complete a quality of life questionnaire at the start and end of treatment

    For participants aged 9-16 years, a special children's version of the questionnaire will be provided

  5. Step 5

    Safety monitoring

    The doctor will monitor any side effects throughout the study

    Local skin reactions at the application site will be evaluated

    The assessment includes checking for redness, peeling, dryness, stinging, burning, and itching

  6. Step 6

    Final evaluation

    After 12 weeks, a final assessment of your acne condition will be performed

    The doctor will evaluate the overall effectiveness of the treatment

    Final laboratory tests and safety assessments will be conducted

Who can join the trial?

16 criteria

  • Must sign an informed consent document before participating in the study
  • Age must be between 9 years and 50 years
  • Must have facial acne with the following characteristics:
    • For ages 14-50: moderate to severe acne (score 3-4 on doctor's assessment)
    • For ages 9-14: 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)
    • May also have acne on upper body (shoulders, upper back, chest) with:
      • Moderate severity (grade 2-3 on doctor's assessment)
      • 20-100 inflammatory spots
      • 20-100 non-inflammatory spots
      • No more than 1 nodule
      • Must be able to reach these areas to apply treatment
      • Must be able to understand the study requirements and potential risks
      • For participants 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: must be stable 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?

14 criteria

  • Age below 12 years or above 65 years
  • Pregnant women or those planning pregnancy during the study period
  • Breastfeeding mothers
  • History of serious allergic reactions to similar medications
  • Current use of other acne treatments (medications applied to skin or taken orally)
  • Presence of other skin conditions that could interfere with evaluating the treatment
  • Severe or nodular acne (deep, painful bumps under the skin)
  • History of skin cancer or pre-cancerous lesions
  • Participation in another clinical trial within the past 30 days
  • Any significant medical condition that could affect study participation
  • Unable to follow study procedures or attend scheduled visits
  • History of poor compliance with medical treatments
  • Use of medications that could interact with the study treatment
  • Recent facial procedures including chemical peels or laser treatments
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Investigated drugs

N-Acetyl-GED-0507-34-LEVO gel is a topical medication being tested for the treatment of acne vulgaris (common acne). This gel is designed to be applied directly to the skin once daily. It's being studied as a new potential treatment option for people suffering from acne breakouts. The trial also includes a vehicle gel, which is a placebo gel that contains the same base ingredients as the active medication but without the active component. This is used as a control to compare the effectiveness of the actual treatment.

What is already known about the treatment

N-Acetyl-GED-0507-34-LEVO gel - A topical medication in gel form being investigated in Phase III clinical trials for the treatment of acne vulgaris. The gel is designed to be applied once daily to affected skin areas for a duration of 12 weeks. While the exact molecular mechanism is still under investigation in clinical trials, this novel formulation represents a new approach to treating common acne. The medication is currently being evaluated for both efficacy and safety in comparison to a vehicle gel placebo, indicating it's in advanced stages of clinical development but not yet approved for general medical use.

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 various types of bumps on the skin, including whiteheads, blackheads, pimples, and sometimes deeper cysts or nodules. The condition most commonly affects the face, chest, and back, where the highest concentration of oil glands exists. Acne develops when excess oil production, dead skin cells, and bacteria combine to create inflammation in the pores. The condition usually begins during puberty due to hormonal changes but can affect people of various ages. The severity can range from mild with occasional breakouts to severe with persistent inflammation and larger lesions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510339-12-00Protocol codeNACGED0507ACN0123AEstimated enrolment380 patientsSponsorPPM Services S.A.

sourced from the EU Clinical Trials Register and site verification

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