A Long-term Safety and Efficacy Study of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Subjects With Acne Vulgaris (GEDACNE-LT)

NCT07389109 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: NAC-GED-0507-ACN-01-23-LT2023-510342-24-00
• Study Type: interventional
• Target: 400
• Locations: 3 countries
• Sites: 59

Brief 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?". 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

Keywords

acne; acne vulgaris

Outcome Measures

Primary Outcomes (34)

• 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

  From enrollment to the end of treatment at 52 weeks

• Frequency of discontinuation of treatment due to TEAEs

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of systolic blood pressure during the study

  mmHg

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of diastolic blood pressure during the study

  mmHg

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of heart rate during the study

  bpm

  From enrollment to the end of treatment at 52 weeks

• Physical examination during the study (height)

  cm

  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.

  From enrollment to the end of treatment at 52 weeks

• Assessment of overall application site irritation over the study duration

  From enrollment to the end of treatment at 52 weeks

• Physical examination during the study (weight)

  kg

  From enrollment to the end of treatment at 52 weeks

• Physical examination during the study (BMI)

  weight (kg) / \[height (m)\]²

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of RBC over the study duration

  unit of measurement 10E12/L

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of WBC over the study duration

  unit of measurement 10E9/L

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of Haematocrit over the study duration

  unit of measurement %

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of Haemoglobin over the study duration

  unit of measurement g/dl

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of MCV over the study duration

  unit of measurement fL

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of MCH over the study duration

  unit of measurement pg

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of MCHC over the study duration

  unit of measurement g/dL

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of Platelets over the study duration

  unit of measurement 10E9/L

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of neutrophils over the study duration

  unit of measurement 10E0/L

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of Lymphocytes over the study duration

  unit of measurement 10E9/L

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of Monocytes over the study duration

  unit of measurement 10E9/L

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of Eosinophils over the study duration

  unit of measurement 10E9/L

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of Basophils over the study duration

  unit of measurement 10E9/L

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline of Differential blood count over the study duration

  unit of measurement %

  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

  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

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline in Triglycerides over the study duration

  unit of measurement mg/dl

  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

  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

  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

  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

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline in HbA1c (glycated haemoglobin) over the study duration

  unit of measurement %

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline in Insulinemia over the study duration

  unit of measurement μU/mL

  From enrollment to the end of treatment at 52 weeks

• Changes from baseline in beta-HCG over the study duration

  postive or negative

  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)

  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)

  From enrollment to the end of treatment at 52 weeks

• Absolute change from baseline in total lesion count at each time point (face)

  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)

  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)

  From enrollment to the end of treatment at 52 weeks

Other Outcomes (3)

• Dermatology Life Quality Index (DLQI) / Children's Dermatology Life Quality Index

  From enrollment to the end of treatment at 52 weeks

• Scar Assessment by Scale for Acne Scar Severity (SCAR-S) evaluation at V2/Baseline, V5/Wk12, V6/Wk26, V7/Wk38 and V8/Wk52 visits

  From enrollment to the end of treatment at 52 weeks

• At selected sites, at V2/Baseline, V5/Wk12 and V8/Wk52 collection of scar 3D photographic documentation will be optional. The area defined for scar assessments is only the face

  From enrollment to the end of treatment at 52 weeks

Study Arms (1)

N-Acetyl-GED-0507-34-Levo 5% gel

EXPERIMENTAL

Drug: N-Acetyl-GED-0507-34-LEVO gel 5%

Interventions

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.

N-Acetyl-GED-0507-34-Levo 5% gel

Eligibility Criteria

• Age: 9 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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:
• Increased androgen production.

Sponsors & Collaborators

• PPM Services S.A.: lead

Study Sites (59)

Azienda Ospedaliero Universitaria Delle Marche

Ancona, AN, 60126, Italy

Location

Azienda USL Toscana Centro

Florence, FI, 50125, Italy

Location

IRCCS Ospedale Policlinico San Martino

Genova, GE, 16132, Italy

Location

Azienda Ospedaliero Universitaria Parma

Parma, PR, 43126, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, 27100, Italy

Location

Azienda Ospedaliera Policlinico Universitario Tor Vergata

Roma, RM, 00133, Italy

Location

I.F.O. Istituti Fisioterapici Ospitalieri

Roma, RM, 00144, Italy

Location

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

Bologna, Italy

Location

Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania

Catania, Italy

Location

University Hospital Of Ferrara

Ferrara, Italy

Location

Universita Degli Studi Di Modena E Reggio Emilia

Modena, Italy

Location

Azienda Ospedaliera Universitaria Federico II Di Napoli

Naples, 80131, Italy

Location

Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli

Naples, Italy

Location

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Novara, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Hospital Santa Maria Della Misericordia

Perugia, Italy

Location

Azienda USL Toscana Centro

Prato, Italy

Location

Fondazione Luigi Maria Monti

Roma, Italy

Location

Specderm Poznanska Sp. j.

Bialystok, Poland

Location

Vitamed Galaj I Cichomski Sp. j.

Bydgoszcz, Poland

Location

DERMAPOLIS Medical Dermatology Center dr n.med. Edyta Gebska

Chorzów, Poland

Location

NZOZ Przychodnia Specjalistyczna "A-DERM-SERWIS"

Częstochowa, Poland

Location

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

Gdansk, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Location

Provita Sp. z o.o.

Katowice, Poland

Location

Silmedic Sp. z o.o.

Katowice, Poland

Location

Vita Longa Sp. z o.o.

Katowice, Poland

Location

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

Krakow, Poland

Location

Jagiellońskie Centrum Innowacji Sp. z o.o.

Krakow, Poland

Location

Amicare Sp. z o.o. S.K.

Lodz, Poland

Location

Dermed Centrum Medyczne Sp. z o.o.

Lodz, Poland

Location

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

Lublin, Poland

Location

Velocity Nova Sp. z o.o.

Lublin, Poland

Location

St-Inspire Sp. z o.o.

Mikołów, Poland

Location

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

Nowa Sól, Poland

Location

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

Olsztyn, Poland

Location

Labderm Essence Sp. z o.o.

Ożarowice, Poland

Location

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

Poznan, Poland

Location

Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie

Rzeszów, Poland

Location

Lukmed 2 Sp. z o.o.

Siedlce, Poland

Location

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

Sosnowiec, Poland

Location

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

Szczecin, Poland

Location

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

Szczecin, Poland

Location

Etg Warszawa Sp. z o.o.

Warsaw, Poland

Location

Klinika Ambroziak Sp. z o.o.

Warsaw, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, Poland

Location

EMC Instytut Medyczny S.A.

Wroclaw, Poland

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, Spain

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain

Location

Sant Joan De Deu Barcelona Hospital

Esplugues de Llobregat, 08950, Spain

Location

Hospital Universitario Virgen De Las Nieves

Granada, Spain

Location

Futuremeds Spain S.L.

Madrid, 28003, Spain

Location

Futuremeds Spain S.L.

Madrid, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, Spain

Location

Hospital Universitario Regional De Malaga

Málaga, 29010, Spain

Location

Hospital Universitario Virgen De La Victoria

Málaga, 29010, Spain

Location

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

Location

Futuremeds Spain S.L.

Seville, 41012, Spain

Location

Instituto Medico Ricart Valencia S.L.

Valencia, Spain

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 5, 2026
• Study Start: December 5, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-10

Locations

ES (12); IT (18); PL (29)