Acne VulgarisPhase 3GEDACNE-1NCT07384195
A Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Patients With Acne Vulgaris (GEDACNE-1)
A Phase 3 study testing N-Acetyl-GED-0507-34-Levo 5% gel in people with Acne Vulgaris, run by PPM Services S.A. at 29 sites in 3 countries.
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 5% gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 407 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 19 Nov 2024to 30 Apr 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
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- 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:
- 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
29 sites in 3 countries.
29 sites in 3 countries
Poland14 sites
Vitamed Galaj I Cichomski Sp. j.
Bydgoszcz
DERMAPOLIS Medical Dermatology Center dr n.med. Edyta Gebska
Chorzów
Provita Sp. z o.o.
Katowice
Silmedic Sp. z o.o.
Katowice
Dermed Centrum Medyczne Sp. z o.o.
Lodz
St-Inspire Sp. z o.o.
Mikołów
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Nowa Sól
Labderm Essence Sp. z o.o.
Ożarowice
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Poznan
Lukmed 2 Sp. z o.o.
Siedlce
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Sosnowiec
Klinika Ambroziak Sp. z o.o.
Warsaw
Royalderm Agnieszka Nawrocka
Warsaw
EMC Instytut Medyczny S.A.
Wroclaw
Italy8 sites
Azienda Ospedaliero Universitaria Delle Marche
Ancona, AN, 60126
Azienda USL Toscana Centro
Florence, FI, 50125
IRCCS Ospedale Policlinico San Martino
Genova, GE, 16132
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, 80131
Azienda Ospedaliero Universitaria Parma
Parma, PR, 43126
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Roma, RM, 00133
I.F.O. Istituti Fisioterapici Ospitalieri
Roma, RM, 00144
Spain7 sites
Sant Joan De Deu Barcelona Hospital
Esplugues de Llobregat, 08950
Futuremeds Spain S.L.
Madrid, 28003
Hospital Universitario Hm Sanchinarro
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
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-1)
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 5% gel, N-Acetyl-GED-0507-34-Levo corresponding vehicle
- Keywords
- acne vulgaris, acne
- 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 5% gelDrug
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 group | Role | What they receive |
|---|---|---|
| N-Acetyl-GED-0507-34-Levo 5% gel | Experimental | Not described Receives: Drug: N-Acetyl-GED-0507-34-Levo 5% gel |
| N-Acetyl-GED-0507-34-Levo corresponding vehicle | Placebo comparator | Not 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.
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
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.
Measured: 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)
Measured: From enrollment to the end of treatment at 12 weeks
Percentage of patients who achieve an IGA success over the study duration (face)
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
Change from baseline in total lesion count over the study duration (face)
Measured: From enrollment to the end of treatment at 12 weeks
Change from baseline in inflammatory lesion count over the study duration (face)
Measured: From enrollment to the end of treatment at 12 weeks
Change from baseline in non-inflammatory lesion count over the study duration (face)
Measured: From enrollment to the end of treatment at 12 weeks
Absolute change from baseline in total lesion count at V5/Wk12 (trunk)
Measured: From enrollment to the end of treatment at 12 weeks
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
Change from baseline in truncal total lesion total count over the study duration
Measured: From enrollment to the end of treatment at 12 weeks
Change from baseline in truncal inflammatory lesion count over the study duration
Measured: From enrollment to the end of treatment at 12 weeks
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.
- First posted3 Feb 2026
- Study start19 Nov 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 407 participants (actual)
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
- NCT07384195
- Sponsor's protocol ID
- NAC-GED-0507-ACN-01-23-A
- Other IDs
- 2023-510339-12-00, 2023
- Acronym
- GEDACNE-1
- 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 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-1)
- ClinicalTrials.gov ID
- NCT07384195
- Acronym / sponsor ID
- GEDACNE-1 / NAC-GED-0507-ACN-01-23-A
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, acne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- PPM Services S.A.University, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 3 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 9 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 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
- Diagnosis at screening and baseline visits:
- 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:
Key exclusion criteria (26 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 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
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 5% gelEach 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. | Drug | N-Acetyl-GED-0507-34-Levo 5% gel |
| N-Acetyl-GED-0507-34-Levo corresponding vehicleAlso: PlaceboEach 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. | Drug | N-Acetyl-GED-0507-34-Levo corresponding vehicle |
Primary outcome
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
Proportion of patients with an IGA success (face) at V5/Wk12.
Time frame: From enrollment to the end of treatment at 12 weeks
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.
10 secondary outcomes
Absolute change from baseline in total lesion count at V5/Wk12 (face)
Time frame: From enrollment to the end of treatment at 12 weeks
Percentage of patients who achieve an IGA success over the study duration (face)
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in total lesion count over the study duration (face)
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in inflammatory lesion count over the study duration (face)
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in non-inflammatory lesion count over the study duration (face)
Time frame: From enrollment to the end of treatment at 12 weeks
Absolute change from baseline in total lesion count at V5/Wk12 (trunk)
Time frame: From enrollment to the end of treatment at 12 weeks
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
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in truncal total lesion total count over the study duration
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in truncal inflammatory lesion count over the study duration
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in truncal non-inflammatory lesion count over the study duration.
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
29 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 5% gel in people with Acne Vulgaris, run by PPM Services S.A. at 29 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 29 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?
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.