Active — Not RecruitingPhase 3

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

Italy400 participantsStarted 2024-11-19

Plain-language 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

Who can participate

Age range9 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Informed consent obtained: Written informed consent, before any study-related procedure, personally signed and dated by the patient if the patient is ≥ 18 years old, or signed and dated by the parents or the legal guardian(s) if the patient is ≥ 9 to \< 18 years old. An additional informed assent form must be signed by patient if ≥ 9 to \<18 years old to confirm his willingness to participate in the study. If the patient becomes 18 years of age during the study, the patient must provide written informed consent at that time to continue study participation
✓. Sex and age: Male and female patients aged ≥ 9 and \<50 years
✓. 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:

Exclusion criteria

What they're measuring

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

Timeframe: From enrollment to the end of treatment at 12 weeks

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

Timeframe: From enrollment to the end of treatment at 12 weeks

Trial details

NCT IDNCT07384195

SponsorPPM Services S.A.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03

View on ClinicalTrials.gov More Acne Vulgaris trials

Plain-language summary

Who can participate

Age range9 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Informed consent obtained: Written informed consent, before any study-related procedure, personally signed and dated by the patient if the patient is ≥ 18 years old, or signed and dated by the parents or the legal guardian(s) if the patient is ≥ 9 to \< 18 years old. An additional informed assent form must be signed by patient if ≥ 9 to \<18 years old to confirm his willingness to participate in the study. If the patient becomes 18 years of age during the study, the patient must provide written informed consent at that time to continue study participation
✓. Sex and age: Male and female patients aged ≥ 9 and \<50 years
✓. 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:

Exclusion criteria

What they're measuring

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

Timeframe: From enrollment to the end of treatment at 12 weeks

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

Timeframe: From enrollment to the end of treatment at 12 weeks