A Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Patients With Acne Vulgaris (GEDACNE-1)

NCT07384195 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: NAC-GED-0507-ACN-01-23-A2023-510339-12-00
• Study Type: interventional
• Target: 400
• Locations: 3 countries
• Sites: 29

Brief 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?". 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. 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

Keywords

acne vulgaris; acne

Outcome Measures

Primary Outcomes (2)

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

  From enrollment to the end of treatment at 12 weeks

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

  IGA success is defined according to the patient's age as: * a score of "clear" (score = 0) or "almost clear" (score = 1) for patients aged ≥ 9 and ≤ 14 years * a score of "clear" (score = 0) or "almost clear" (score = 1) in IGA at V5/Wk12 for patients aged \> 14 and \< 50 years.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (10)

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

  From enrollment to the end of treatment at 12 weeks

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

  From enrollment to the end of treatment at 12 weeks

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

  From enrollment to the end of treatment at 12 weeks

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

  From enrollment to the end of treatment at 12 weeks

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

  From enrollment to the end of treatment at 12 weeks

Other Outcomes (4)

• Dermatology Life Quality Index (DLQI) completed by the patient at the Baseline and Week 12/EoT visits

  From enrollment to the end of treatment at 12 weeks

• Children's Dermatology Life Quality Index (C-DLQI for patients from 9 to 16 years old), completed by the patient at the Baseline and Week 12/EoT visits

  From enrollment to the end of treatment at 12 weeks

• SCAR-S Scar Assessment at the Baseline and Week 12/EoT visits

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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

EXPERIMENTAL

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

N-Acetyl-GED-0507-34-Levo corresponding vehicle

PLACEBO COMPARATOR

Drug: N-Acetyl-GED-0507-34-Levo corresponding vehicle

Interventions

N-Acetyl-GED-0507-34-Levo 5% gel 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 12 consecutive weeks.

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

N-Acetyl-GED-0507-34-Levo corresponding vehicle DRUG

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.

Also known as: Placebo

N-Acetyl-GED-0507-34-Levo corresponding vehicle

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
• 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.
• 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.

You may not qualify if:

• 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
• 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 therapies 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:

Sponsors & Collaborators

• PPM Services S.A.: lead

Study Sites (29)

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 Ospedaliera Universitaria Federico II Di Napoli

Naples, 80131, Italy

Location

Vitamed Galaj I Cichomski Sp. j.

Bydgoszcz, Poland

Location

DERMAPOLIS Medical Dermatology Center dr n.med. Edyta Gebska

Chorzów, Poland

Location

Provita Sp. z o.o.

Katowice, Poland

Location

Silmedic Sp. z o.o.

Katowice, Poland

Location

Dermed Centrum Medyczne Sp. z o.o.

Lodz, Poland

Location

St-Inspire Sp. z o.o.

Mikołów, Poland

Location

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

Nowa Sól, Poland

Location

Labderm Essence Sp. z o.o.

Ożarowice, Poland

Location

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

Poznan, 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

Klinika Ambroziak Sp. z o.o.

Warsaw, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, Poland

Location

EMC Instytut Medyczny S.A.

Wroclaw, Poland

Location

Sant Joan De Deu Barcelona Hospital

Esplugues de Llobregat, 08950, Spain

Location

Futuremeds Spain S.L.

Madrid, 28003, Spain

Location

Hospital Universitario Hm Sanchinarro

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

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Gels

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 3, 2026
• Study Start: November 19, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-10

Locations

PL (14); IT (8); ES (7)