Acne VulgarisPhase 3GEDACNE-LTNCT07389109
A Long-term Safety and Efficacy Study of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Subjects With Acne Vulgaris (GEDACNE-LT)
A Phase 3 study testing N-Acetyl-GED-0507-34-LEVO gel 5% in people with Acne Vulgaris, run by PPM Services S.A. at 59 sites in 3 countries.
Trial summary
The clinical trial aims to test the long term safety of a new drug for acne vulgaris. The trial is performed to answer this question "Is it safe to apply the IMP daily for up to 52 weeks?". 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 gel 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 59 sitesin 3 countries
- Study dates
- 5 Dec 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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. 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.
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- 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 screening visit
- A non-hormonal intrauterine device (IUD) must be started at least 2 months before the screening visit.
Who cannot join
- 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
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- 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:
- Increased androgen production.
- Adrenal origin: e.g., Cushing's disease, 21-hydroxylase deficiency;
- 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 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.
Trial locations and contacts
59 sites in 3 countries.
59 sites in 3 countries
Poland29 sites
Specderm Poznanska Sp. j.
Bialystok
Vitamed Galaj I Cichomski Sp. j.
Bydgoszcz
DERMAPOLIS Medical Dermatology Center dr n.med. Edyta Gebska
Chorzów
NZOZ Przychodnia Specjalistyczna "A-DERM-SERWIS"
Częstochowa
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk
Uniwersyteckie Centrum Kliniczne
Gdansk
Provita Sp. z o.o.
Katowice
Silmedic Sp. z o.o.
Katowice
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
Dermed Centrum Medyczne Sp. z o.o.
Lodz
Clinical Best Solutions Sp. z o.o. S.K.
Lublin
Velocity Nova Sp. z o.o.
Lublin
St-Inspire Sp. z o.o.
Mikołów
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Nowa Sól
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Olsztyn
Labderm Essence Sp. z o.o.
Ożarowice
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Poznan
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszów
Lukmed 2 Sp. z o.o.
Siedlce
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Sosnowiec
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
Klinika Ambroziak Sp. z o.o.
Warsaw
Royalderm Agnieszka Nawrocka
Warsaw
EMC Instytut Medyczny S.A.
Wroclaw
Italy18 sites
Azienda Ospedaliero Universitaria Delle Marche
Ancona, AN, 60126
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
Azienda USL Toscana Centro
Florence, FI, 50125
IRCCS Ospedale Policlinico San Martino
Genova, GE, 16132
Universita Degli Studi Di Modena E Reggio Emilia
Modena
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, 80131
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Naples
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Novara
Azienda Ospedaliera di Padova
Padova
Azienda Ospedaliero Universitaria Parma
Parma, PR, 43126
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100
Hospital Santa Maria Della Misericordia
Perugia
Azienda USL Toscana Centro
Prato
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Roma, RM, 00133
I.F.O. Istituti Fisioterapici Ospitalieri
Roma, RM, 00144
Fondazione Luigi Maria Monti
Roma
Spain12 sites
Hospital Universitario Fundacion Alcorcon
Alcorcón
Hospital De La Santa Creu I Sant Pau
Barcelona
Sant Joan De Deu Barcelona Hospital
Esplugues de Llobregat, 08950
Hospital Universitario Virgen De Las Nieves
Granada
Futuremeds Spain S.L.
Madrid, 28003
Futuremeds Spain S.L.
Madrid
Hospital Universitario 12 De Octubre
Madrid
Hospital Universitario Regional De Malaga
Málaga, 29010
Hospital Universitario Virgen De La Victoria
Málaga, 29010
Hospital Quironsalud Infanta Luisa
Seville, 41010
Futuremeds Spain S.L.
Seville, 41012
Instituto Medico Ricart Valencia S.L.
Valencia
About this study
The clinical trial aims to test the long term safety of a new drug for acne vulgaris. The trial is performed to answer this question "Is it safe to apply the IMP daily for up to 52 weeks?". The trial aims to accurately measure the safety and the effects of the new treatment (N-Acetyl-GED-0507-34-LEVO gel 5%) and to achieve this, patients will be review the drug containing the active ingredient.
Participants will:
- Take drug every day for up to 52 weeks
- Visit the site once every 4 weeks for checkups and tests (where applicable) for the first 3 months of treatment, then visit the site every 13 weeks approximately for checkups and tests (where applicable).
- Record on a diary the daily/weekly applications of the study drug at home, and record any adverse events
- Conditions
- Acne Vulgaris
- Being tested
- N-Acetyl-GED-0507-34-LEVO gel 5%
- 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-LEVO gel 5%Drug
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 up to 52 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| N-Acetyl-GED-0507-34-Levo 5% gel | Experimental | Not described Receives: Drug: N-Acetyl-GED-0507-34-LEVO gel 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs, TEAEs, ADRs, SAEs
Incidence of all Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) throughout the study; with special attention to local TEAEs concerning the treated facial area (local dermal safety), and systemic TEAEs
Measured: From enrollment to the end of treatment at 52 weeks
Frequency of discontinuation of treatment due to TEAEs
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of systolic blood pressure during the study
mmHg
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of diastolic blood pressure during the study
mmHg
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of heart rate during the study
bpm
Measured: From enrollment to the end of treatment at 52 weeks
Physical examination during the study (height)
cm
Measured: From enrollment to the end of treatment at 52 weeks
Change from baseline of local tolerability- Application site signs/symptoms during the study
Local tolerability will be evaluated based on the following signs and symptoms: application site non-lesional erythema, application site exfoliation, and application site dryness, stinging, burning, itching. For each sign/symptom, a severity score will be assigned using a 4-point scale from 0 = absent to 3 = severe. Of note, only a sign/symptom occurring after the first application of study medication that requires additional therapy or discontinuation of treatment or judged from the Investigator as clinically significant will be documented as a TEAE.
Measured: From enrollment to the end of treatment at 52 weeks
Assessment of overall application site irritation over the study duration
Measured: From enrollment to the end of treatment at 52 weeks
Physical examination during the study (weight)
kg
Measured: From enrollment to the end of treatment at 52 weeks
Physical examination during the study (BMI)
weight (kg) / [height (m)]²
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of RBC over the study duration
unit of measurement 10E12/L
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of WBC over the study duration
unit of measurement 10E9/L
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Haematocrit over the study duration
unit of measurement %
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Haemoglobin over the study duration
unit of measurement g/dl
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of MCV over the study duration
unit of measurement fL
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of MCH over the study duration
unit of measurement pg
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of MCHC over the study duration
unit of measurement g/dL
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Platelets over the study duration
unit of measurement 10E9/L
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of neutrophils over the study duration
unit of measurement 10E0/L
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Lymphocytes over the study duration
unit of measurement 10E9/L
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Monocytes over the study duration
unit of measurement 10E9/L
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Eosinophils over the study duration
unit of measurement 10E9/L
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Basophils over the study duration
unit of measurement 10E9/L
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Differential blood count over the study duration
unit of measurement %
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline in AST (GOT) over the study duration
unit of measurement U/L
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline in ALT (GPT) over the study duration
unit of measurement U/L
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline in Triglycerides over the study duration
unit of measurement mg/dl
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline in Total cholesterol over the study duration
unit of measurement mg/dl
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline in HDL-C (high-density lipoprotein cholesterol) over the study duration
unit of measurement mg/dl
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline in LDL-C (low-density lipoprotein cholesterol) over the study duration
unit of measurement mg/dl
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline in Plasma glucose over the study duration
unit of measurement mmol/L
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline in HbA1c (glycated haemoglobin) over the study duration
unit of measurement %
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline in Insulinemia over the study duration
unit of measurement μU/mL
Measured: From enrollment to the end of treatment at 52 weeks
Changes from baseline in beta-HCG over the study duration
postive or negative
Measured: From enrollment to the end of treatment at 52 weeks
Secondary outcomes (10)
Percentage of patients who have improvement of IGA score at each time point (1, 2 points), vs baseline score (face)
Measured: From enrollment to the end of treatment at 52 weeks
The percentage change from baseline in total lesion count (inflammatory plus non-inflammatory) at each time point (face)
Measured: From enrollment to the end of treatment at 52 weeks
Absolute change from baseline in total lesion count at each time point (face)
Measured: From enrollment to the end of treatment at 52 weeks
Change from baseline in inflammatory lesion count (percentage and absolute), at each time point (face)
Measured: From enrollment to the end of treatment at 52 weeks
Change from baseline in non-inflammatory lesion count (percentage and absolute), at each time point. (face)
Measured: From enrollment to the end of treatment at 52 weeks
Percentage of patients who have improvement of PGA score at each time point (1, 2 points), vs baseline score
Measured: From enrollment to the end of treatment at 52 weeks
The percentage change from baseline in total lesion count (inflammatory plus non-inflammatory) at each time point (trunk)
Measured: From enrollment to the end of treatment at 52 weeks
Absolute change from baseline in total lesion count at each time point (trunk)
Measured: From enrollment to the end of treatment at 52 weeks
Change from baseline in inflammatory lesion count (percentage and absolute), at each time point (trunk)
Measured: From enrollment to the end of treatment at 52 weeks
Change from baseline in non-inflammatory lesion count (percentage and absolute), at each time point. (trunk)
Measured: From enrollment to the end of treatment at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start5 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PPM Services S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389109
- Sponsor's protocol ID
- NAC-GED-0507-ACN-01-23-LT
- Other IDs
- 2023-510342-24-00, 2023
- Acronym
- GEDACNE-LT
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Safety and Efficacy Study of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Subjects With Acne Vulgaris (GEDACNE-LT)
- ClinicalTrials.gov ID
- NCT07389109
- Acronym / sponsor ID
- GEDACNE-LT / NAC-GED-0507-ACN-01-23-LT
- Conditions
- Acne Vulgaris
- Keywords
- acne, acne vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- PPM Services S.A.University, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial aims to test the long term safety of a new drug for acne vulgaris. The trial is performed to answer this question "Is it safe to apply the IMP daily for up to 52 weeks?". The trial aims to accurately measure the safety and the effects of the new treatment (N-Acetyl-GED-0507-34-LEVO gel 5%) and to achieve this, patients will be review the drug containing the active ingredient.
Participants will:
- Take drug every day for up to 52 weeks
- Visit the site once every 4 weeks for checkups and tests (where applicable) for the first 3 months of treatment, then visit the site every 13 weeks approximately for checkups and tests (where applicable).
- Record on a diary the daily/weekly applications of the study drug at home, and record any adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N-Acetyl-GED-0507-34-Levo 5% gel | Experimental | Drug: N-Acetyl-GED-0507-34-LEVO gel 5% |
Who may qualify
- Ages
- 9 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (27 listed)
- Acne:
- Beard and facial/body hair, tattoos:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetyl-GED-0507-34-LEVO gel 5%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 up to 52 consecutive weeks. | Drug | N-Acetyl-GED-0507-34-Levo 5% gel |
Primary outcome
Incidence of AEs, TEAEs, ADRs, SAEs
Time frame: From enrollment to the end of treatment at 52 weeks
Incidence of all Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) throughout the study; with special attention to local TEAEs concerning the treated facial area (local dermal safety), and systemic TEAEs
Frequency of discontinuation of treatment due to TEAEs
Time frame: From enrollment to the end of treatment at 52 weeks
Changes from baseline of systolic blood pressure during the study
Time frame: From enrollment to the end of treatment at 52 weeks
mmHg
Changes from baseline of diastolic blood pressure during the study
Time frame: From enrollment to the end of treatment at 52 weeks
mmHg
Changes from baseline of heart rate during the study
Time frame: From enrollment to the end of treatment at 52 weeks
bpm
Physical examination during the study (height)
Time frame: From enrollment to the end of treatment at 52 weeks
cm
Change from baseline of local tolerability- Application site signs/symptoms during the study
Time frame: From enrollment to the end of treatment at 52 weeks
Local tolerability will be evaluated based on the following signs and symptoms: application site non-lesional erythema, application site exfoliation, and application site dryness, stinging, burning, itching. For each sign/symptom, a severity score will be assigned using a 4-point scale from 0 = absent to 3 = severe. Of note, only a sign/symptom occurring after the first application of study medication that requires additional therapy or discontinuation of treatment or judged from the Investigator as clinically significant will be documented as a TEAE.
Assessment of overall application site irritation over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
Physical examination during the study (weight)
Time frame: From enrollment to the end of treatment at 52 weeks
kg
Physical examination during the study (BMI)
Time frame: From enrollment to the end of treatment at 52 weeks
weight (kg) / [height (m)]²
Changes from baseline of RBC over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement 10E12/L
Changes from baseline of WBC over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L
Changes from baseline of Haematocrit over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement %
Changes from baseline of Haemoglobin over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement g/dl
Changes from baseline of MCV over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement fL
Changes from baseline of MCH over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement pg
Changes from baseline of MCHC over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement g/dL
Changes from baseline of Platelets over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L
Changes from baseline of neutrophils over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement 10E0/L
Changes from baseline of Lymphocytes over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L
Changes from baseline of Monocytes over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L
Changes from baseline of Eosinophils over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L
Changes from baseline of Basophils over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement 10E9/L
Changes from baseline of Differential blood count over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement %
Changes from baseline in AST (GOT) over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement U/L
Changes from baseline in ALT (GPT) over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement U/L
Changes from baseline in Triglycerides over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement mg/dl
Changes from baseline in Total cholesterol over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement mg/dl
Changes from baseline in HDL-C (high-density lipoprotein cholesterol) over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement mg/dl
Changes from baseline in LDL-C (low-density lipoprotein cholesterol) over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement mg/dl
Changes from baseline in Plasma glucose over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement mmol/L
Changes from baseline in HbA1c (glycated haemoglobin) over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement %
Changes from baseline in Insulinemia over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
unit of measurement μU/mL
Changes from baseline in beta-HCG over the study duration
Time frame: From enrollment to the end of treatment at 52 weeks
postive or negative
10 secondary outcomes
Percentage of patients who have improvement of IGA score at each time point (1, 2 points), vs baseline score (face)
Time frame: From enrollment to the end of treatment at 52 weeks
The percentage change from baseline in total lesion count (inflammatory plus non-inflammatory) at each time point (face)
Time frame: From enrollment to the end of treatment at 52 weeks
Absolute change from baseline in total lesion count at each time point (face)
Time frame: From enrollment to the end of treatment at 52 weeks
Change from baseline in inflammatory lesion count (percentage and absolute), at each time point (face)
Time frame: From enrollment to the end of treatment at 52 weeks
Change from baseline in non-inflammatory lesion count (percentage and absolute), at each time point. (face)
Time frame: From enrollment to the end of treatment at 52 weeks
Percentage of patients who have improvement of PGA score at each time point (1, 2 points), vs baseline score
Time frame: From enrollment to the end of treatment at 52 weeks
The percentage change from baseline in total lesion count (inflammatory plus non-inflammatory) at each time point (trunk)
Time frame: From enrollment to the end of treatment at 52 weeks
Absolute change from baseline in total lesion count at each time point (trunk)
Time frame: From enrollment to the end of treatment at 52 weeks
Change from baseline in inflammatory lesion count (percentage and absolute), at each time point (trunk)
Time frame: From enrollment to the end of treatment at 52 weeks
Change from baseline in non-inflammatory lesion count (percentage and absolute), at each time point. (trunk)
Time frame: From enrollment to the end of treatment at 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
59 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-Acetyl-GED-0507-34-LEVO gel 5% in people with Acne Vulgaris, run by PPM Services S.A. at 59 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 10 inclusion and 27 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: under way, not looking for participants, 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 59 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of AEs, TEAEs, ADRs, SAEs (time frame: From enrollment to the end of treatment at 52 weeks). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.