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New acne gel put to the test for Year-Long safety

NCT ID NCT07389109

Disease control Sponsor: PPM Services S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study is testing whether a new gel applied daily for up to 52 weeks is safe for people with acne. About 400 participants will use the gel on their face and upper body and visit the clinic regularly for checkups. The main goal is to track any side effects, not to measure how well it clears acne.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
N-Acetyl-GED-0507-34-LEVO gel 5%
What this could lead to
If successful, this could provide a new, safe daily gel option for managing acne over the long term.
What could go wrong
This is a safety-focused study, so effectiveness is not the main goal. The gel may cause skin irritation or other side effects, and results may not apply to all acne types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Patients who turn 50 during the pivotal study can roll over to the LT study. * Diagnosis at screening and baseline visits: * a. Patients affected by facial acne vulgaris with an Investigator's Global Assessment (IGA) score: =1 or 2 for pivotal-naïve\* patients not included in pivotal 12 Week treatment studies ≥ 0 for patients completing the 12-Week treatment period according to protocol in the pivotal Phase 3 trials (NAC-GED-0507-ACN-01-23-A and NAC-GED-0507-ACN-01-23-B) * b. Patients affected by truncal acne (optional criteria) on areas of the trunk (shoulders, upper back and upper anterior chest) accessible for patient's self- application of study medication with a Physician Global Assessment (PGA) severity grade: =1 or 2 for pivotal-naïve\* patients not included in the pivotal 12Week treatment studies ≥ 0 and \< 4 for patients completing the 12-Week treatment period according to protocol in the pivotal Phase 3 trials (NAC-GED-0507-ACN-01-23-A and NAC-GED-0507-ACN-01-23-B) * Pivotal-naïve: Patients not rolling over from NAC-GED-0507-ACN-01-23-A and NAC-GED-0507-ACN-01-23-B. If the pivotal-naïve patient is ≥ 9 and ≤ 14 years old and declined participation to pivotal Phase 3 study, a 12-week period should run before inclusion in the present study. During the 12-week period the patients will be allowed to follow their doctor's instructions regarding treatment of acne. * 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: 1. Hormonal oral, implantable, transdermal, or injectable contraceptives must be stable for at least 6 months before the screening visit 2. A non-hormonal intrauterine device (IUD) must be started at least 2 months before the screening visit. Exclusion Criteria: * Acne: * 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 * 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 medication. Patients with a history of an allergic reaction or significant sensitivity to the formulations' ingredients. * Topical therapies: Patients who are currently using, plan to use during the study, or discontinued less than 4 weeks before study baseline the use of prescribed 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, plan to 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, plan to 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, plan to 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: 1. Increased androgen production. 1. Adrenal origin: e.g., Cushing's disease, 21-hydroxylase deficiency; 2. Ovarian origin: e.g., polycystic ovarian syndrome, ovarian hyperthecosis 2. Cryptococcosis disseminated 3. Dimorphic fungal infections 4. Behçet's disease 5. Systemic lupus erythematosus (SLE). * Investigative studies: Participation in the evaluation of any other 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), 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.

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Conditions

The condition(s) this trial relates to.

acne Acne Vulgaris

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acne vulgaris

Contacts and locations

Locations

  • Amicare Sp. z o.o. S.K.

    Lodz, Poland

  • Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli

    Naples, Italy

  • Azienda Ospedaliera Policlinico Universitario Tor Vergata

    Roma, RM, 00133, Italy

  • Azienda Ospedaliera Universitaria Federico II Di Napoli

    Naples, 80131, Italy

  • Azienda Ospedaliera di Padova

    Padova, Italy

  • Azienda Ospedaliero Universitaria Delle Marche

    Ancona, AN, 60126, Italy

  • Azienda Ospedaliero Universitaria Parma

    Parma, PR, 43126, Italy

  • Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania

    Catania, Italy

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

    Bologna, Italy

  • Azienda Ospedaliero-Universitaria Maggiore Della Carita

    Novara, Italy

  • Azienda USL Toscana Centro

    Florence, FI, 50125, Italy

  • Azienda USL Toscana Centro

    Prato, Italy

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

    Gdansk, Poland

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

    Krakow, Poland

  • Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.

    Sosnowiec, Poland

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

    Lublin, Poland

  • DERMAPOLIS Medical Dermatology Center dr n.med. Edyta Gebska

    Chorzów, Poland

  • Dermed Centrum Medyczne Sp. z o.o.

    Lodz, Poland

  • EMC Instytut Medyczny S.A.

    Wroclaw, Poland

  • Etg Warszawa Sp. z o.o.

    Warsaw, Poland

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

    Olsztyn, Poland

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, PV, 27100, Italy

  • Fondazione Luigi Maria Monti

    Roma, Italy

  • Futuremeds Spain S.L.

    Madrid, 28003, Spain

  • Futuremeds Spain S.L.

    Madrid, Spain

  • Futuremeds Spain S.L.

    Seville, 41012, Spain

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, Spain

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010, Spain

  • Hospital Santa Maria Della Misericordia

    Perugia, Italy

  • Hospital Universitario 12 De Octubre

    Madrid, Spain

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Spain

  • Hospital Universitario Regional De Malaga

    Málaga, 29010, Spain

  • Hospital Universitario Virgen De La Victoria

    Málaga, 29010, Spain

  • Hospital Universitario Virgen De Las Nieves

    Granada, Spain

  • I.F.O. Istituti Fisioterapici Ospitalieri

    Roma, RM, 00144, Italy

  • IRCCS Ospedale Policlinico San Martino

    Genova, GE, 16132, Italy

  • Instituto Medico Ricart Valencia S.L.

    Valencia, Spain

  • Jagiellońskie Centrum Innowacji Sp. z o.o.

    Krakow, Poland

  • Klinika Ambroziak Sp. z o.o.

    Warsaw, Poland

  • Labderm Essence Sp. z o.o.

    Ożarowice, Poland

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

    Szczecin, Poland

  • Lukmed 2 Sp. z o.o.

    Siedlce, Poland

  • NZOZ Przychodnia Specjalistyczna "A-DERM-SERWIS"

    Częstochowa, Poland

  • Provita Sp. z o.o.

    Katowice, Poland

  • Royalderm Agnieszka Nawrocka

    Warsaw, Poland

  • Sant Joan De Deu Barcelona Hospital

    Esplugues de Llobregat, 08950, Spain

  • Silmedic Sp. z o.o.

    Katowice, Poland

  • Specderm Poznanska Sp. j.

    Bialystok, Poland

  • St-Inspire Sp. z o.o.

    Mikołów, Poland

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

    Nowa Sól, Poland

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

    Poznan, Poland

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

    Szczecin, Poland

  • Universita Degli Studi Di Modena E Reggio Emilia

    Modena, Italy

  • University Hospital Of Ferrara

    Ferrara, Italy

  • Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie

    Rzeszów, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Poland

  • Velocity Nova Sp. z o.o.

    Lublin, Poland

  • Vita Longa Sp. z o.o.

    Katowice, Poland

  • Vitamed Galaj I Cichomski Sp. j.

    Bydgoszcz, Poland

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