Ongoing Clinical Trials for Acne

Currently, there are 6 clinical trials investigating new treatments for acne, a common skin condition that causes pimples, blackheads, and whiteheads. These studies are taking place across several European countries and are testing various topical gels and oral medications to improve acne management and reduce symptoms. Some trials focus specifically on treating moderate to severe acne, while others examine long-term safety and effectiveness of new treatments.

Clinical trial locations

• France
  • Study Comparing Isotretinoin with Doxycycline, Tretinoin, and Adapalene for Moderate Acne in Patients with Skin of Color
• Germany
  • Study on the Effectiveness and Safety of Clindamycin and Tretinoin Gel for Patients with Papulopustular Acne
• Greece
  • Study on the Effectiveness of Clindamycin and Tretinoin Gel for Treating Acne in Patients
• Italy
  • Title: Long-term safety study of N-Acetyl-GED-0507-34-LEVO gel 5% applied to the skin for patients with acne vulgaris
  • Study of N-Acetyl-GED-0507-34-LEVO 5% gel applied daily for 12 weeks in patients with acne vulgaris
  • Study of N-Acetyl-GED-0507-34-LEVO gel 5% applied daily for treating acne vulgaris
• Poland
  • Title: Long-term safety study of N-Acetyl-GED-0507-34-LEVO gel 5% applied to the skin for patients with acne vulgaris
  • Study of N-Acetyl-GED-0507-34-LEVO 5% gel applied daily for 12 weeks in patients with acne vulgaris
  • Study of N-Acetyl-GED-0507-34-LEVO gel 5% applied daily for treating acne vulgaris
• Spain
  • Title: Long-term safety study of N-Acetyl-GED-0507-34-LEVO gel 5% applied to the skin for patients with acne vulgaris
  • Study of N-Acetyl-GED-0507-34-LEVO 5% gel applied daily for 12 weeks in patients with acne vulgaris
  • Study of N-Acetyl-GED-0507-34-LEVO gel 5% applied daily for treating acne vulgaris

Study Comparing Isotretinoin with Doxycycline, Tretinoin, and Adapalene for Moderate Acne in Patients with Skin of Color

This trial is taking place in France and focuses on comparing different treatment approaches for moderate acne in individuals with darker skin tones. The study specifically targets people with Fitzpatrick skin types IV, V, and VI.

Who can participate: The trial is open to women and men aged between 13 and 30 years who have moderate acne and darker skin tones. Participants must have a cell phone capable of taking high-quality selfies and must be affiliated with French social coverage. Informed consent is required from participants, or from their parents or guardians if they are under 18.

Who cannot participate: Pregnant women, those planning pregnancy during the study, or breastfeeding mothers cannot join. People with known allergies to isotretinoin, severe liver disease, high cholesterol or triglyceride levels, or those taking medications that may interact with isotretinoin are excluded. The trial also excludes individuals with a history of depression, other mental health issues, inflammatory bowel disease, or those not using effective birth control methods if they are of childbearing potential.

What the trial involves: This study compares the effectiveness of oral isotretinoin with standard treatments currently used for moderate acne. Standard treatments may include doxycycline, tretinoin cream, adapalene cream, or lymecycline. The main goal is to determine whether starting treatment with isotretinoin earlier can better reduce acne severity over six months. Participants will take selfies throughout the study to track changes in their skin, and these images will be analyzed using a special algorithm to assess acne severity and skin pigmentation issues.

Investigational drugs: The trial tests isotretinoin, an oral medication that reduces the amount of oil released by skin glands and helps the skin renew itself more quickly. This is compared with standard care treatments that include various topical creams and oral medications commonly used for acne management.

Study of N-Acetyl-GED-0507-34-LEVO 5% gel applied daily for 12 weeks in patients with acne vulgaris

This trial is being conducted in Poland, Spain, and Italy and examines a new topical treatment for acne vulgaris that is applied directly to the skin once daily for 12 weeks.

Who can participate: The study includes individuals aged between 9 and 49 years with facial acne. For those over 14 years, moderate to severe acne is required, while those aged 9-14 need at least mild acne. Participants must have between 20 and 100 inflammatory spots and 20 and 100 non-inflammatory spots, with no more than 1 large nodule. Women who can become pregnant must use effective birth control for at least 6 months before starting if using hormonal methods, or have an IUD in place for at least 2 months.

Who cannot participate: The trial excludes individuals outside the specified age range, pregnant or breastfeeding women, those with allergies to similar medications, people currently using other acne treatments, and individuals with severe skin conditions other than acne. Those who have participated in other clinical trials within the last 30 days or who have serious medical conditions that could interfere with the study are also excluded.

What the trial involves: The study tests N-Acetyl-GED-0507-34-Levo gel 5%, comparing it with a vehicle gel without the active medication. The treatment is applied to affected areas of the face and, if needed, to the upper chest, shoulders, and upper back. Healthcare providers will monitor changes in acne by counting different types of spots and evaluating overall skin appearance throughout the 12-week period.

Investigational drugs: N-Acetyl-GED-0507-34-LEVO gel is a topical medication designed for once-daily application. It is being tested against a placebo vehicle gel to evaluate its effectiveness in treating acne vulgaris.

Study of N-Acetyl-GED-0507-34-LEVO gel 5% applied daily for treating acne vulgaris

This study, also conducted in Poland, Spain, and Italy, tests the same N-Acetyl-GED-0507-34-Levo gel 5% medication over a 12-week period, focusing on both facial and trunk acne.

Who can participate: Participants must be between 9 and 50 years old with facial acne. For ages 14-50, moderate to severe acne is required, while those aged 9-14 need at least mild acne. The requirements for acne lesion counts are similar to the previous study. Participants may also have acne on the upper body, including shoulders, upper back, and chest, which they can reach for self-application. Effective birth control is required for women of childbearing potential.

Who cannot participate: Similar to the previous trial, pregnant or breastfeeding women, those with allergies to similar medications, people using other acne treatments, and individuals with severe conditions or recent participation in other trials cannot join. Those unable to follow study procedures or attend scheduled visits are also excluded.

What the trial involves: The study evaluates how well the gel reduces different types of acne lesions, including inflammatory lesions like red, swollen bumps and non-inflammatory lesions like blackheads and whiteheads. Throughout the study, participants will have their acne assessed using standardized scoring systems, and safety monitoring includes checking for skin reactions such as redness, peeling, dryness, stinging, burning, or itching.

Investigational drugs: N-Acetyl-GED-0507-34-LEVO gel is tested against a vehicle gel placebo to compare effectiveness in treating acne vulgaris over 12 weeks of daily application.

Study on the Effectiveness and Safety of Clindamycin and Tretinoin Gel for Patients with Papulopustular Acne

This trial in Germany examines a combination gel containing clindamycin and tretinoin for treating papulopustular acne, a type of acne characterized by red, inflamed bumps and pimples.

Who can participate: Women, men, and adolescents aged between 12 and 65 years can participate. Participants must have papulopustular acne with at least 25 non-inflammatory lesions and at least 20 inflammatory lesions on the face, with no more than 2 nodular lesions. The severity must be assessed as grade 2, 3, or 4 on a specific scale. Written consent is required, and for those under 18, both the participant and legal guardian must provide consent. Women who can become pregnant must use highly effective birth control and have a negative pregnancy test before starting.

Who cannot participate: The trial excludes individuals outside the specified age range, pregnant or breastfeeding women, those with known allergies to the study medications, people using other acne treatments within a certain period before the study, and those with certain skin conditions that might interfere with results. People who have recently participated in other clinical trials or have medical conditions that could affect outcomes are also excluded.

What the trial involves: The study compares a new clindamycin and tretinoin gel with an existing treatment called Acnatac and a placebo over 12 weeks. Clindamycin is an antibiotic that reduces bacteria and inflammation, while tretinoin is a form of vitamin A that helps the skin renew itself more quickly. The primary goal is to assess the change in the number of inflammatory and total lesions from the start of the study to week 12.

Investigational drugs: The trial tests Clindamycin/Tretinoin Gel, a combination medication that helps reduce acne-causing bacteria and promotes skin renewal. This is compared with Acnatac Gel, which contains the same active ingredients and is already used to treat acne.

Long-term safety study of N-Acetyl-GED-0507-34-LEVO gel 5% applied to the skin for patients with acne vulgaris

This long-term study conducted in Poland, Spain, and Italy evaluates the safety and effectiveness of N-Acetyl-GED-0507-34-Levo gel 5% when used for up to 52 weeks, which is one full year.

Who can participate: The study is open to individuals aged 9 to 49 years with facial acne. For new patients, mild to moderate acne severity is required, while continuing patients from previous studies may have any severity level. Participants may also have body acne on shoulders, upper back, or upper chest. Those under 18 must have parent or legal guardian approval. Women who can become pregnant must use effective birth control, including hormonal contraceptives for at least 6 months or a non-hormonal IUD for at least 2 months before screening.

Who cannot participate: The trial excludes individuals outside the age range of 12 to 65 years, pregnant or breastfeeding women, those with known allergies to topical acne medications, and people with severe or cystic acne requiring oral medication. Those currently using other acne treatments, with skin conditions other than acne, with a history of skin cancer, or who have participated in another clinical trial within the past 30 days cannot join. People with uncontrolled hormone-related conditions, weakened immune systems, active skin infections, or who are unable to follow study procedures for 52 weeks are also excluded.

What the trial involves: This study examines how safe and effective the gel treatment is when used for up to one year. The medication is applied once daily to affected areas on the face and, in some cases, the upper chest, shoulders, and upper back. Regular check-ups occur at weeks 12, 26, 38, and 52 to monitor skin response, count acne lesions, and track any side effects. The study also evaluates how the treatment affects participants’ quality of life through questionnaires.

Investigational drugs: N-Acetyl-GED-0507-34-LEVO gel is a topical medication applied directly to the skin once daily. This long-term study evaluates whether it is safe and effective for extended use in treating acne vulgaris.

Study on the Effectiveness of Clindamycin and Tretinoin Gel for Treating Acne in Patients

This trial in Greece compares two different gels containing clindamycin and tretinoin for treating acne vulgaris over a 12-week period.

Who can participate: Males and non-pregnant, non-breastfeeding females aged between 12 and 40 years can join. Participants must have a clinical diagnosis of mild to severe facial acne with at least 25 non-inflammatory lesions and at least 20 inflammatory lesions on the face, but no more than 2 nodulocystic lesions. They must have been using the same type of non-medicated makeup, cleanser, or facial products for at least 14 days before starting and agree to continue without changes. Participants must be in good general health, and females of childbearing potential must use acceptable birth control and have a negative pregnancy test at the start.

Who cannot participate: Pregnant or breastfeeding women, individuals with known allergies to study medications or their ingredients, people who have used other acne treatments recently, and those with certain skin conditions that might interfere with results cannot participate. Those who have taken part in another clinical trial recently, have medical conditions that could affect outcomes, are unable to follow study procedures, or attend scheduled visits are also excluded.

What the trial involves: The study compares a test product, Clindamycin + Tretinoin/Verisfield gel, with a reference product, Acnatac®/Meda gel, and a placebo. Participants apply the gel to their face once daily for 12 weeks. The purpose is to determine if the test product is as effective as the reference product in reducing acne symptoms. Throughout the study, changes in the number of inflamed and non-inflamed acne lesions are monitored, and participants are observed for any side effects such as skin reactions.

Investigational drugs: Clindamycin + Tretinoin/Verisfield Gel combines clindamycin, an antibiotic that reduces bacteria and inflammation, with tretinoin, a form of vitamin A that helps the skin renew itself. This is compared with Acnatac®/Meda Gel, which contains the same active ingredients, to ensure they provide similar benefits in reducing acne.

Summary

The 6 ongoing clinical trials for acne treatment are distributed across several European countries, with a notable concentration of trials in Poland, Spain, and Italy, where three studies are testing the same investigational drug. France, Germany, and Greece each host one unique trial focusing on different treatment approaches.

A significant focus across these trials is on topical treatments, with four studies examining N-Acetyl-GED-0507-34-LEVO gel 5%, including one long-term safety study lasting up to 52 weeks. This represents a major research effort to evaluate this new topical medication for acne treatment. Two trials focus on combination gels containing clindamycin and tretinoin, testing them against existing treatments and placebos.

The trials show diversity in their target populations, with age ranges varying from as young as 9 years to 65 years, though most focus on adolescents and young adults. One trial in France specifically targets individuals with skin of color, addressing the need for research in diverse populations. Treatment durations range from 12 weeks for most studies to up to 52 weeks for the long-term safety evaluation.

Most trials test topical gel formulations applied once daily, though one study in France examines oral isotretinoin compared with standard care treatments. This variety in treatment approaches reflects ongoing efforts to find effective and safe options for different types and severities of acne, from mild to severe cases.