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

3 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
NZOZ Przychodnia Specjalistyczna A-DERM-Serwis Czestochowa Poland

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Specderm Poznanska Sp. j. Bialystok Poland
Amicare Sp. z o.o. S.K. Lodz Poland
Fondazione Luigi Maria Monti Rome Italy
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Hospital Universitario Virgen De Las Nieves Granada Spain
Vita Longa Sp. z o.o. Katowice Poland
Universita’ Degli Studi Di Modena E Reggio Emilia Modena Italy
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Olsztyn Poland
Azienda Ospedaliera di Padova Padua Italy
Jagiellońskie Centrum Innowacji Sp. z o.o. Cracow Poland
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Etg Neuroscience Sp. z o.o. Warsaw Poland
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Azienda USL Toscana Centro Prato Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Czgdkqf Bqadp Kjpfpkbylqm Pzffhytf Sjs z ogml Gdansk Poland
Lasyu Cpfyau Sbqb dr Tunnst Kcrokojthzc di Aynlltb Kwnioujd Szczecin Poland
Aulaogu Uumex Sxmxoxinx Lrtvoa Dq Bjobuit Bologna Italy
Uxvqqygrwimmlr Cgquqhx Kwsednyha Gdansk Poland
Hofkjyos Dp Lx Sbpgi Crhp I Skfe Per Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
01.09.2024
Poland Poland
Not recruiting
01.09.2024
Spain Spain
Not recruiting
01.09.2024

Trial locations

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.

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 ID:
2023-510341-19-00
Protocol code:
NACGED0507ACN0123B
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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

    Recruiting

    3 1 1 1
    France
  • Study on the Effectiveness and Safety of Clindamycin and Tretinoin Gel for Patients with Papulopustular Acne

    Recruiting

    3 1 1
    Investigated drugs:
    Germany