Long-term Safety and Efficacy Evaluation of N-Acetyl-GED-0507-34-Levo Gel 5% in Patients with Acne Vulgaris

The primary objective of this study is to evaluate the long-term **safety** of N-Acetyl-GED-0507-34-Levo gel, applied once daily for a treatment period of up to 52 weeks in patients with **acne vulgaris**. This is clinically relevant as it aims to ensure that the topical treatment does not pose any adverse effects over an extended period, which is crucial for chronic conditions like acne vulgaris that often require long-term management.

The secondary objective is to assess the long-term **efficacy** of the 5% N-Acetyl-GED-0507-34-Levo gel under the same application conditions. Determining the sustained effectiveness of the treatment is important for providing a reliable therapeutic option for patients suffering from acne vulgaris, potentially improving their quality of life by reducing the severity and frequency of acne outbreaks.

The clinical trial involves a total of **80 participants** diagnosed with **acne vulgaris**. The study population includes both male and female subjects, with an age range of 9 to less than 50 years. Participants who turned 50 during the pivotal study are eligible to continue in the long-term study. The trial population was selected based on specific inclusion criteria, including the requirement for informed consent and the ability to comprehend the study's nature and purpose. Participants are required to have a diagnosis of facial acne vulgaris, with an Investigator’s Global Assessment (IGA) score of 1 or 2 for pivotal-naïve patients, or a score of 0 or higher for those completing the 12-week treatment period in previous pivotal Phase 3 trials. Additionally, the study considers patients with truncal acne, provided the areas are accessible for self-application of the study medication. Women of childbearing potential must use effective contraception throughout the study. The trial includes a vulnerable population, ensuring that participants and their guardians, if applicable, can cooperate with the study requirements. Lifestyle considerations such as diet and physical activity are not specified in the available data.

The clinical trial is designed to evaluate the long-term safety and efficacy of **N-Acetyl-GED-0507-34-Levo GEL 5%** in patients with **acne vulgaris**. This study is a randomized, double-blind, controlled trial with a total treatment period of up to 52 weeks. Participants will be required to apply the gel topically once daily. The trial will commence with a screening visit to confirm eligibility based on specific inclusion criteria, such as age and diagnosis of acne vulgaris, and to obtain informed consent. The trial will include follow-up visits at regular intervals to monitor safety and efficacy endpoints, including changes in lesion counts and Investigator’s Global Assessment (IGA) scores.

The primary objective is to assess the long-term safety of the gel, with safety endpoints including the incidence of adverse events, changes in vital signs, and local tolerability at the application site. Secondary efficacy endpoints will evaluate improvements in acne severity and quality of life using standardized scales. Participants will be involved in the study for the entire 52-week period unless early termination is warranted due to adverse events or non-compliance with study protocols. The end-of-study visit will involve a comprehensive assessment to evaluate the overall outcomes of the treatment. The expected length of participant involvement is approximately one year, with conditions for early termination including significant adverse reactions or withdrawal of consent.

The clinical trial involves the use of an **experimental medication** known as N-Acetyl-GED-0507-34-Levo GEL 5%. This medication is formulated as a gel and is intended for **topical use**. The active substance in this formulation is (S)-3-(4-acetamidophenyl)-2-methoxypropanoic acid, a chemical compound also referred to by synonyms such as RGR-1999AC and NAC-GED-0507. The gel is applied once daily (OD) with a maximum daily dose of 5.6 grams, and the total treatment period can extend up to 52 weeks. The maximum total dose over the treatment period is 2038.4 grams. The product is classified as a new chemical entity and is not designated as an orphan drug. The manufacturer of this product is PPM SERVICES SA.

In this study, there are no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments mentioned. The focus is solely on evaluating the long-term safety and efficacy of the experimental gel in subjects with **acne vulgaris**. Participant compliance with the dosing schedule is monitored throughout the study to ensure adherence to the once-daily application regimen. The trial aims to provide comprehensive data on the safety profile of the gel when used over an extended period.

The efficacy of N-Acetyl-GED-0507-34-Levo gel 5% in the treatment of **acne vulgaris** will be assessed through several endpoints. For facial acne, the primary efficacy endpoints include the percentage of patients who show improvement in the Investigator’s Global Assessment (IGA) score at each time point, as well as the percentage and absolute change from baseline in total lesion count, which includes both inflammatory and non-inflammatory lesions. Similarly, for truncal acne, the efficacy will be evaluated by the percentage of patients with improvement in the Physician Global Assessment (PGA) score, and changes in total lesion count from baseline.

Additional efficacy assessments will involve the Dermatology Life Quality Index (DLQI) or the Children’s Dermatology Life Quality Index (C-DLQI) for patients aged 9 to 16 years, which will be completed at baseline, week 12, and week 52 visits. Furthermore, an additional assessment by the Scale for Acne Severity will be conducted at baseline, week 12, week 26, week 38, and week 52. These assessments will be performed prior to any investigator evaluations to ensure unbiased patient responses. Optional documentation for additional assessments will be conducted at baseline, week 12, and week 52, focusing solely on the facial area.