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Acne VulgarisPhase 3GEDACNE-2NCT07384208

A Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5% in Patients With Acne Vulgaris (GEDACNE 2)

A Phase 3 study testing N-Acetyl-GED-0507-34-Levo in people with Acne Vulgaris, run by PPM Services S.A. at 31 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The clinical trial aims to test a new drug for acne vulgaris. The trial is performed to answer this question "Is it possible to reduce the number of skin lesions on your face/trunk, after daily applications for 12 consecutive weeks of a new drug?". Read more about this study

Who is it for?
Ages 9 to 50 years
Conditions the study is for
Acne Vulgaris
What is being tested?
N-Acetyl-GED-0507-34-Levo
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
398 participants
Where
31 sitesin 3 countries
Study dates
19 Nov 2024to 28 May 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Informed consent obtained: Written informed consent, before any study-related procedure, personally signed and dated by the patient if the patient is ≥ 18 years old, or signed and dated by the parents or the legal guardian(s) if the patient is ≥ 9 to < 18 years old. An additional informed assent form must be signed by patient if ≥ 9 to <18 years old to confirm his willingness to participate in the study. If the patient becomes 18 years of age during the study, the patient must provide written informed consent at that time to continue study participation
  • Sex and age: Male and female patients aged ≥ 9 and <50 years
  • Diagnosis at screening and baseline visits:
  • a) Patients affected by facial acne vulgaris with: Investigator's Global Assessment (IGA) score:
  • equal to 3-4 if patient is > 14 and < 50 years old
  • ≥ 2 if the patient is ≥ 9 and ≤ 14 years old. Face Inflammatory lesions: ≥ 20 and ≤ 100 inflammatory lesions (papules and pustules) and ≤ 1 nodules on the face. Face Non-inflammatory lesions: ≥ 20 and ≤ 100 non-inflammatory lesions (open and closed comedones) on the face
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  • b) Patients affected also by truncal acne (optional criteria): The patient has a truncal acne on areas of the trunk (shoulders, upper back and upper anterior chest) accessible for patient's self-application of study medication with a severity grade equal to 2 or 3 on the Physician Global Assessment (PGA) scale. The patient has a minimum of 20 inflammatory lesions (papules and pustules) and 20 non-inflammatory lesions (open and closed comedones) but no more than 100 non-inflammatory lesions and no more than 100 inflammatory lesions and ≤ 1 nodules on areas of the trunk (shoulders, upper back and upper anterior chest) reachable to patient's self-application of study medication at screening and baseline.
  • Full comprehension: Patients and their parents/legal guardian(s) (for <18 years old patients) can comprehend the whole nature and purpose of the study, including possible risks and side effects, and are able to cooperate with the Investigator and to comply with the requirements of the entire study
  • Contraception and fertility: Women of childbearing potential must be using an effective contraception method during the entire duration of the study (effective contraception methods are those considered at least "acceptable" according to CTFG Recommendations). A prior stable treatment period is required for the following reliable methods of contraception:
  • Hormonal oral, implantable, transdermal, or injectable contraceptives must be stable for at least 6 months before the baseline visit
  • A non-hormonal intrauterine device (IUD) must be started at least 2 months before the baseline visit.

Who cannot join

  • Acne:
  • Patients with a known history of acne persistent and unresponsive to topical and/or oral treatments within 6 months before randomization
  • Patients with generalized or localized acne forms other than acne vulgaris, e.g., acne conglobata, acne fulminans, acne rosacea, secondary acne (chloracne, drug-induced acne, etc), nodule-cystic acne
  • Patients with acne requiring systemic treatment
  • Beard and facial/body hair, tattoos:
  • Patients with a beard or who intend to grow a beard and/or to perform a facial tattoo during the study
Show all 26Show fewer
  • Patients with facial hair or facial tattoos that could interfere with study assessments in the investigator's opinion
  • For patients with truncal acne: body hair, tattoos (or who intend to perform them) on the shoulders, upper back or upper anterior chest accessible to self-application of study medication by the patient (evaluable area) that may interfere with the study assessments in the investigator's opinion
  • Skin diseases: Patients with other active skin diseases (e.g., urticaria, atopic dermatitis, sunburn, seborrheic dermatitis, perioral dermatitis, rosacea, skin malignancies) or active skin infections in the facial or truncal region (bacterial, fungal, or viral) or any other facial or truncal disease or condition that might interfere with the evaluation of acne or place the patient at unacceptable risk
  • Allergy: Known or suspected hypersensitivity to any active or inactive ingredient in the study medications. Patients with a history of an allergic reaction or significant sensitivity to the formulations' ingredients
  • Topical therapies: Patients who are currently using, will use during the study, or discontinued less than 4 weeks before study baseline the use of prescribed and/or over-the-counter topical therapies for the treatment of acne, including but not limited to: corticosteroids, antibiotics, azelaic acid, benzoyl peroxide, salicylates, α-hydroxy/glycolic acid, any other topical cosmetic therapy for acne and retinoids on the face/trunk
  • Topical skin care products and procedures: Patients who are currently using, will use during the study, or discontinued less than 4 weeks before study baseline the use of products for facial/truncal application containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non-mild cleansers or moisturizers containing retinol, salicylic or alpha- or beta-hydroxy acids, facial/truncal procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion
  • Phototherapy: Patients who are currently using, will use during the study, or discontinued less than 4 weeks before study baseline phototherapy for the treatment of acne, including but not limited to: UV-A, UV-B, heliotherapy. Patients who have the need or plan to be exposed to artificial tanning devices or excessive sunlight during the study
  • Systemic therapies: Patients who are currently using, will use during the study, or discontinued less than 12 weeks before study baseline the use of systemic therapies for the treatment of acne, including but not limited to: antibiotics, isotretinoin. Other systemic therapy that could affect the patient's acne (i.e., anabolics, lithium, EGRF inhibitors, iodides, systemic corticosteroids - except inhaled corticosteroids or intrathecal corticosteroids - or other immunosuppressants), in the opinion of the investigator
  • Known systemic diseases that can lead to acneiform eruptions:
  • Increased androgen production. 1) Adrenal origin: e.g., Cushing's disease, 21-hydroxylase deficiency; 2) Ovarian origin: e.g., polycystic ovarian syndrome, ovarian hyperthecosis
  • Cryptococcosis disseminated
  • Dimorphic fungal infections
  • Behçet's disease
  • Systemic lupus erythematosus (SLE)
  • Investigative studies: Participation in the evaluation of any investigational product or device within 24 weeks before study baseline
  • Diseases: Patients with underlying uncontrolled or unstable conditions (including but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal and auto-immune), which, in the Investigator's opinion, could significantly compromise the patient's safety and/or place the patient at an unacceptable risk. Any condition that in the investigator's opinion would make it unsafe for the patient to participate in the study
  • Alcohol and other substance abuse: History of alcohol or other substance abuse within one year before screening
  • Communication: Patient(s) and parents/legal guardian(s) (if applicable) unable to communicate or cooperate with the investigator due to e.g., language problems, impaired cerebral function, impaired mental conditions
  • Reliability: Patients who may be unreliable for the study including patients who are unable to return for the scheduled visits
  • Pregnancy: Pregnant or breastfeeding women or women of childbearing potential who are planning to become pregnant during the study. *For all female patients of childbearing potential, pregnancy test result must be negative at screening.

Trial locations and contacts

31 sites in 3 countries.

31 sites in 3 countries

Poland15 sites

  • Specderm Poznanska Sp. j.

    Bialystok

  • NZOZ Przychodnia Specjalistyczna "A-DERM-SERWIS"

    Częstochowa

  • Centrum Badan Klinicznych Pi-House Sp. z o.o.

    Gdansk

  • Uniwersyteckie Centrum Kliniczne

    Gdansk

  • Vita Longa Sp. z o.o.

    Katowice

  • Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.

    Krakow

  • Jagiellońskie Centrum Innowacji Sp. z o.o.

    Krakow

  • Amicare Sp. z o.o. S.K.

    Lodz

  • Clinical Best Solutions Sp. z o.o. S.K.

    Lublin

  • Velocity Nova Sp. z o.o.

    Lublin

  • Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.

    Olsztyn

  • Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie

    Rzeszów

  • Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki

    Szczecin

  • Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.

    Szczecin

  • Etg Warszawa Sp. z o.o.

    Warsaw

Other trials in Poland

Italy10 sites

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

    Bologna

  • Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania

    Catania

  • University Hospital Of Ferrara

    Ferrara

  • Universita Degli Studi Di Modena E Reggio Emilia

    Modena

  • Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli

    Naples

  • Azienda Ospedaliero-Universitaria Maggiore Della Carita

    Novara

  • Azienda Ospedaliera di Padova

    Padova

  • Hospital Santa Maria Della Misericordia

    Perugia

  • Azienda USL Toscana Centro

    Prato

  • Fondazione Luigi Maria Monti

    Roma

Other trials in Italy

Spain6 sites

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón

  • Hospital De La Santa Creu I Sant Pau

    Barcelona

  • Hospital Universitario Virgen De Las Nieves

    Granada

  • Futuremeds Spain S.L.

    Madrid

  • Hospital Universitario 12 De Octubre

    Madrid

  • Instituto Medico Ricart Valencia S.L.

    Valencia

Other trials in Spain

About this study

Official title: A Phase III Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5%, Applied Once Daily for 12 Weeks in Patients With Acne Vulgaris (GEDACNE-2)

The clinical trial aims to test a new drug for acne vulgaris. The trial is performed to answer this question "Is it possible to reduce the number of skin lesions on your face/trunk, after daily applications for 12 consecutive weeks of a new drug?". The trial aims to accurately measure the effects of the new treatment (N-Acetyl-GED-0507-34-LEVO gel 5%) and to achieve this, patients will be randomly assigned to one of the following treatments:

  • Study drug 1: test item, containing active ingredient
  • Study drug 2: a preparation not containing any active ingredient (vehicle). Researchers will compare active to vehicle to see if there are differences in the efficacy.
Read more

Participants will:

  • Apply drug or a placebo every day for 12 weeks
  • Visit the site once every 4 weeks for checkups and tests (where applicable)
  • Record on a diary the daily applications of the study drug at home, and record any adverse events
Conditions
Acne Vulgaris
Being tested
N-Acetyl-GED-0507-34-Levo, N-Acetyl-GED-0507-34-Levo corresponding vehicle
Keywords
acne, acne vulgaris
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-Acetyl-GED-0507-34-LevoDrug

    Each patient will apply a fingertip unit of N-Acetyl-GED-0507-34-Levo 5% gel as a thin film, once daily (OD), to the entire facial skin area and the affected skin areas of the trunk accessible for self-application (i.e., shoulders, upper back, and upper anterior chest) for 12 consecutive weeks.

  • N-Acetyl-GED-0507-34-Levo corresponding vehicleDrug

    Also called Placebo

    Each patient will apply a fingertip unit of N-Acetyl-GED-0507-34-Levo corresponding vehicle as a thin film, once daily (OD), to the entire facial skin area and the affected skin areas of the trunk accessible for self-application (i.e., shoulders, upper back, and upper anterior chest) for 12 consecutive weeks.

Study groups in NCT07384208
Study groupRoleWhat they receive
N-Acetyl-GED-0507-34-Levo 5% gelExperimentalNot described
Receives: Drug: N-Acetyl-GED-0507-34-Levo
N-Acetyl-GED-0507-34-Levo corresponding vehiclePlacebo comparatorNot described
Receives: Drug: N-Acetyl-GED-0507-34-Levo corresponding vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The relative change from baseline in total lesion count (inflammatory plus non-inflammatory) at V5/Wk12 on the face

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Proportion of patients with an IGA success (face) at V5/Wk12.

    The Investigator Global Assessment (IGA) for acne is a 5-point clinical scale (0-4) used by dermatologists to assess overall acne severity based on lesion type and extent. It ranges from 0 (clear) to 4 (severe), providing a rapid, qualitative snapshot of facial acne, commonly used to measure treatment efficacy.

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (10)

  1. Absolute change from baseline in total lesion count at V5/Wk12 (face)

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Percentage of patients who achieve an IGA success over the study duration (face)

    i.e., score of 1 [almost clear] or 0 [clear] for patients aged ≥ 9 and ≤ 14 years; score of 1 [almost clear] or 0 [clear] and at least a two-grade improvement from baseline for patients aged > 14 and < 50 years)

    Measured: From enrollment to the end of treatment at 12 weeks

  3. Change from baseline in total lesion count over the study duration (face)

    Measured: From enrollment to the end of treatment at 12 weeks

  4. Change from baseline in inflammatory lesion count over the study duration (face)

    Measured: From enrollment to the end of treatment at 12 weeks

  5. Change from baseline in non-inflammatory lesion count over the study duration. (face)

    Measured: From enrollment to the end of treatment at 12 weeks

  6. Absolute change from baseline in total lesion count at V5/Wk12 (trunk)

    Measured: From enrollment to the end of treatment at 12 weeks

  7. Percentage of patients who achieve a PGA score of 1 (almost clear) or 0 (clear) and at least a two-grade improvement from baseline over the study duration

    The Physician Global Assessment (PGA) for acne is a standardized 5-point scale (0-4) used by clinicians to assess acne severity based on the number and type of lesions. It is frequently used in clinical trials and practice to measure treatment success, with a score of "clear" (0) or "almost clear" (1) usually indicating a successful outcome.

    Measured: From enrollment to the end of treatment at 12 weeks

  8. Change from baseline in truncal total lesion total count over the study duration

    Measured: From enrollment to the end of treatment at 12 weeks

  9. Change from baseline in truncal inflammatory lesion count over the study duration

    Measured: From enrollment to the end of treatment at 12 weeks

  10. Change from baseline in truncal non-inflammatory lesion count over the study duration.

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2026
  2. Study start19 Nov 2024
  3. Primary completion28 May 2026
  4. Study completion28 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07384208
Sponsor's protocol ID
NAC-GED-0507-ACN-01-23-B
Other IDs
2023-510341-19-00, 2023
Acronym
GEDACNE-2
Status last verified
Sep 2026
First submitted
12 Jan 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing N-Acetyl-GED-0507-34-Levo in people with Acne Vulgaris, run by PPM Services S.A. at 31 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Poland, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The relative change from baseline in total lesion count (inflammatory plus non-inflammatory) at V5/Wk12 on the face (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07384208.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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