Efficacy and Safety Evaluation of N-Acetyl-GED-0507-34-Levo Gel 5% in Patients with Acne Vulgaris: A Phase III Randomized Controlled Trial
- Trial ID
- 2023-510341-19-00
- Protocol
- NACGED0507ACN0123B
- Sponsor
- PPM Services S.A.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this phase III clinical study is to evaluate the **efficacy** and **safety** of N-Acetyl-GED-0507-34-Levo gel 5% in comparison to its corresponding vehicle gel. This topical treatment is applied once daily for 12 weeks in patients diagnosed with **acne vulgaris**. The clinical relevance of this study lies in its potential to offer a new therapeutic option for managing acne vulgaris, a common dermatological condition that can significantly impact patients' quality of life. The study aims to determine whether the active gel formulation provides superior outcomes in terms of reducing acne lesions and improving skin condition compared to the vehicle gel, thereby contributing to the optimization of acne treatment protocols.
Participants
The clinical trial involves a total of **80 participants** diagnosed with **acne vulgaris**. The study population includes both male and female subjects, aged between 9 and 49 years. Participants were selected based on specific inclusion criteria, including an Investigator’s Global Assessment (IGA) score and the presence of a defined number of inflammatory and non-inflammatory lesions on the face, with optional truncal acne assessment. The trial population is characterized by individuals who are capable of understanding the study's nature and purpose, including potential risks and side effects, and who can comply with study requirements. Women of childbearing potential are required to use effective contraception throughout the study duration. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The study aims to evaluate the efficacy and safety of N-Acetyl-GED-0507-34-Levo gel compared to a vehicle gel, applied once daily for 12 weeks.
Plans and Procedures
The clinical trial is designed to evaluate the **efficacy** and safety of N-Acetyl-GED-0507-34-Levo gel 5% in patients with **acne vulgaris**. This is a phase III, randomized, double-blind, controlled study comparing the active gel to a corresponding vehicle gel. The trial will involve a 12-week treatment period, during which participants will apply the gel topically once daily. The study aims to assess the relative change from baseline in total lesion count and the proportion of patients achieving Investigator's Global Assessment (IGA) success at the end of the study.
Participants will be involved in the study for approximately 12 weeks, with the possibility of early termination if they experience significant adverse events or fail to comply with study protocols. The study will begin with a screening visit to confirm eligibility based on criteria such as age, diagnosis of facial acne vulgaris, and ability to comprehend the study's nature. Following the screening, eligible participants will attend a baseline visit to establish initial lesion counts and other baseline measurements.
Throughout the study, participants will attend follow-up visits to monitor progress, assess safety, and adjust treatment as necessary. The primary endpoints will be evaluated at the final visit, which occurs at week 12. Secondary endpoints include changes in lesion counts over the study duration and assessments of quality of life. Safety and tolerability will be monitored through the incidence of adverse events, changes in vital signs, and physical examinations. The study is expected to conclude by November 2025, with recruitment starting in September 2024.
Treatment
The clinical trial involves the evaluation of **N-Acetyl-GED-0507-34-Levo GEL 5%**, a topical gel formulation containing the active substance **(S)-3-(4-acetamidophenyl)-2-methoxypropanoic acid**. This investigational product is applied once daily for a duration of 12 weeks. The maximum daily dose is 5.6 grams, with a total maximum dose of 470.4 grams over the treatment period. The gel is intended for **topical use** and is classified as a new chemical entity. The product is manufactured by PPM SERVICES SA and is not a pediatric formulation. Participant compliance with the dosing schedule is monitored throughout the study to ensure adherence to the treatment regimen.
The study also includes a comparator treatment, the **N-acetyl-ged-0507-34-levo corresponding vehicle**, which serves as a placebo. This vehicle gel is applied in the same manner as the experimental gel, once daily for 12 weeks. The vehicle gel does not contain the active substance and is used to assess the efficacy and safety of the active gel by providing a baseline for comparison. The use of the vehicle gel allows for the evaluation of the therapeutic effects of the active ingredient in the treatment of acne vulgaris.
Efficacy
The efficacy of N-Acetyl-GED-0507-34-Levo gel 5% in the treatment of **acne vulgaris** will be assessed through a series of primary and secondary endpoints. The primary efficacy endpoints include the relative change from baseline in total lesion count (inflammatory plus non-inflammatory) on the face at week 12, and the proportion of patients achieving Investigator's Global Assessment (IGA) success at the same time point. IGA success is defined as a score of "clear" (score = 0) or "almost clear" (score = 1) for patients aged 9 to 14 years, and for those aged over 14 to under 50 years, a score of "clear" or "almost clear" with at least a two-score point reduction in IGA.
Secondary efficacy endpoints will evaluate both facial and truncal acne. These include the absolute change from baseline in total lesion count at week 12, the percentage of patients achieving IGA success over the study duration, and changes from baseline in total, inflammatory, and non-inflammatory lesion counts over the study duration. For truncal acne, similar assessments will be made using the Physician Global Assessment (PGA) scale. Additionally, the Dermatology Life Quality Index (DLQI) and Children's Dermatology Life Quality Index (C-DLQI) will be used to assess the impact on quality of life at baseline and week 12.
Efficacy assessments will be conducted at specified time points, with the primary endpoint evaluations occurring at week 12. The study will utilize validated scales and patient-reported outcomes to ensure accurate and reliable data collection. The analysis will focus on the comparison between the active treatment and the corresponding vehicle gel, applied once daily for 12 weeks.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Informed consent obtained
- Male and female patients aged ≥ 9 and <50 years
- Diagnosis at screening and baseline visits: a) Patient 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) Optional: 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 equals 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 lesion and no more than 100 inflammatory lesion and ≤ 1 nodules on 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.
- 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
- 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: a) Hormonal oral, implantable, transdermal, or injectable contraceptives must be stable for at least 6 months before the baseline visit b) A non-hormonal intrauterine device (IUD) must be started at least 2 months before the baseline visit.
Exclusion Criteria
- 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
- 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
- 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
- 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
- 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
- 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
- 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 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: i. Increased androgen production. 1) Adrenal origin: e.g., Cushing’s disease, 21-hydroxylase deficiency; 2) Ovarian origin: e.g., polycystic ovarian syndrome, ovarian hyperthecosis ii. Cryptococcosis disseminated iii. Dimorphic fungal infections iv. Behçet’s disease v. Systemic lupus erythematosus (SLE)
- Participation in the evaluation of any investigational product or device within 24 weeks before study baseline
- Patient 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
- History of alcohol or other substance abuse within one year before screening
- Patient(s) and parents/guardian(s) (if applicable) unable to communicate or cooperate with the investigator due to e.g., language problems, impaired cerebral function, bad mental conditions
- Patients who may be unreliable for the study including patients who are unable to return for the scheduled visits
- *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 Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Italy | Not Recruiting | 01 Sept 2024 | 100 |
 Poland | Not Recruiting | 01 Sept 2024 | 150 |
 Spain | Not Recruiting | 01 Sept 2024 | 60 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
N-acetyl-ged-0507-34-levo corresponding vehicle | Placebo | N/A | — | — | — | N/A |
N-Acetyl-GED-0507-34-Levo GEL 5% | Test | GEL | TOPICAL USE | 5.6 | 12 | PRD5423583 |