Randomized, Double-Blind Study on the Efficacy and Safety of Clindamycin/Tretinoin Gel Versus Acnatac Gel and Vehicle in Papulopustular Acne Patients

The primary objective of this double-blind, randomized clinical study is to compare the **efficacy** of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) against Acnatac® 10 mg/g + 0.25 mg/g Gel and a vehicle in reducing inflammatory and total lesions in patients with **papulopustular acne** at Day 84 ± 4. This is clinically relevant as it aims to establish the therapeutic effectiveness of the test gel formulation in managing acne, a common dermatological condition that can significantly impact quality of life.

Secondary objectives include:

• Comparing the efficacy of the test gel versus the reference gel and vehicle in reducing non-inflammatory lesions at Day 84 ± 4.
• Evaluating the reduction of inflammatory, non-inflammatory, and total lesions at all other time points.
• Assessing the clinical response of "success" at Day 84 ± 4.
• Examining changes in the Investigator's Global Assessment (IGA).
• Determining overall therapeutic success.
• Comparing the safety and tolerability of the test gel versus the reference gel and vehicle.

The clinical trial focuses on evaluating the efficacy of Clindamycin/Tretinoin Gel in comparison to Acnatac(R) Gel and a vehicle in reducing inflammatory and total lesions in individuals diagnosed with **papulopustular acne**. The study population comprises women, men, and adolescents aged between 12 and 65 years, with both genders being included. Participants are required to have a diagnosis of papulopustular acne, characterized by at least 25 non-inflammatory lesions and 20 inflammatory lesions on the face, with no more than 2 nodular lesions. The trial includes individuals with an Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4. Female participants of childbearing potential must use a highly efficient contraceptive method throughout the study and provide a negative urine pregnancy test prior to commencement. The trial population was selected based on these criteria, but the total number of participants has not been disclosed by the sponsor. The study does not specify any particular lifestyle considerations such as diet or physical activity. Participants include a vulnerable population, as indicated by the inclusion of adolescents. The sponsor has not provided information on the total number of participants involved in the trial.

The clinical trial is designed as a **randomized**, **double-blind**, controlled study to evaluate the efficacy and safety of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) compared to Acnatac 10 mg/g + 0.25 mg/g Gel and a vehicle in patients with **papulopustular acne**. The trial aims to assess the reduction in inflammatory and total lesion counts over a period of 12 weeks, with the primary endpoint being the percent change in inflammatory lesion count from baseline to week 12. Secondary endpoints include changes in non-inflammatory lesion counts and overall therapeutic success as evaluated by both the investigator and the patient.

Participants will be involved in the study for approximately 12 weeks, with the trial expected to conclude by May 2026. The study will commence with an inclusion visit, where eligibility criteria such as age, diagnosis of papulopustular acne, and consent requirements are verified. Participants must be between 12 and 65 years of age, with specific lesion counts and an Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4. Women of childbearing potential must use a highly effective contraceptive method and have a negative urine pregnancy test prior to study initiation.

Following the inclusion visit, participants will attend a series of follow-up visits at regular intervals to monitor progress and assess treatment efficacy and safety. These visits will include assessments of lesion counts and IGA scores, as well as evaluations of adverse events and treatment tolerability. The end-of-study visit will mark the completion of the trial, where final assessments will be conducted to determine the overall therapeutic success and any changes in acne severity.

Participants may be withdrawn from the study if they experience significant adverse events, fail to comply with study procedures, or if the investigator deems it necessary for their safety. The trial's design ensures that all data collected will contribute to a comprehensive evaluation of the test product's efficacy and safety compared to the reference product and vehicle.

The clinical trial involves the use of **Clindamycin Tretinoin Gel** as the experimental medication. This gel formulation contains the active substances **clindamycin** and **tretinoin**, both of chemical origin. The gel is manufactured by Dermapharm AG and is intended for **cutaneous use**. The dosage of the gel is specified as 10 mg/g of clindamycin and 0.25 mg/g of tretinoin. Participants are instructed to apply the gel topically, with a maximum daily dose of 3.57 grams and a total maximum dose of 300 grams over a treatment period of up to 12 weeks. Compliance with the dosing schedule is monitored throughout the study to ensure adherence to the treatment regimen.

The study also includes a **Vehicle to Clindamycin Tretinoin Gel** as a placebo comparator. This vehicle is used to match the appearance and application method of the active gel but does not contain the active substances. It is also applied cutaneously with the same maximum daily and total dose limits as the active gel, ensuring that any observed effects can be attributed to the active ingredients rather than the formulation itself.

Additionally, the trial utilizes **Acnatac 10mg/g + 0.25mg/g Gel** as a comparator treatment. This gel, produced by Viatris Healthcare GmbH, contains the same active substances, clindamycin and tretinoin, in identical concentrations to the experimental gel. The pharmaceutical form is a gel, and it is administered cutaneously. The dosing schedule mirrors that of the experimental gel, with a maximum daily dose of 3.57 grams and a total maximum dose of 300 grams over a 12-week period. This comparator serves to evaluate the efficacy and safety of the experimental gel against an established treatment.

The efficacy of the Clindamycin/Tretinoin Gel in the treatment of **papulopustular acne** will be assessed through a double-blind, randomized clinical study. The primary efficacy endpoints include the percent change in inflammatory lesion count and total lesion count from baseline (Day 0) to week 12 (Day 84). Secondary efficacy endpoints will evaluate the percent change from baseline to the end of treatment (Visit 8) in non-inflammatory lesion count and total lesion count, as well as changes at various timepoints including Visit 2 through Visit 7. Additionally, absolute changes in lesion counts and the proportion of subjects achieving a clinical response, defined as an Investigator's Global Assessment (IGA) score reduction of at least 2 grades from baseline, will be analyzed.

Data collection will occur at multiple visits throughout the study, with assessments at baseline (Visit 1) and subsequent visits (Visit 2 to Visit 8). The IGA will be used to evaluate changes in acne severity, and both investigators and patients will assess overall therapeutic success at the end of treatment. The incidence of adverse events and tolerability will also be monitored from Visit 2 to Visit 8. The study aims to provide a comprehensive evaluation of the gel's efficacy in reducing acne lesions over a 12-week treatment period.