Clinical Research Directory

Study to Determine Efficacy, Safety, and Tolerability of B244 as a Topical Spray in Subjects With Moderate to Severe Acne Vulgaris

This is a phase 2b, randomized, double-blind, vehicle-controlled clinical trial evaluating the efficacy, safety, and tolerability of B244 compared to vehicle in the treatment of moderate to severe acne vulgaris in adolescents and adults. Participants who meet the study entry criteria will be randomized in a 1:1 ratio to receive twice daily topical doses of B244 O.D. 5.0 or vehicle (control) for 12 weeks.

Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne

The purpose of this study is to evaluate the safety and efficacy of denifanstat compared with matching placebo in participants with moderate to severe acne vulgaris who are ≥12 years of age. After the 12-week treatment phase, a subset of approximately 530 participants will have the option to consent to an open-label extension phase for an additional 40 weeks of treatment.

The Efficacy and Safety of Winona Barrier Special Cream in Post-acne Erythema a Parallel Randomized Controlled Study

The goal of this study is to evaluate the efficacy and safety of winona barrier special cream in post-acne erythema(PAE). The main questions it aims to answer are: whether winona barrier special cream can improve facial skin erythema, transepidermal water loss, water content of stratum corneum, pH,melanin, lipidomic and microbiodemic in patients with PAE . type of study:clinical trial participant population/health conditions The study proposes to recruit 60 PAE patients and 20 healthy individuals The checks of patients were randomly selected to use winona barrier special cream on one side and the Basal Water on the other side. the sampes of surface skin are collected on week0, week4 and week8. Measurements of erythema, transepidermal water loss, stratum corneum water content, pH, and melanin were taken from fixed lesion sites on both cheeks before on week0, week4 and week8. Researchers will compare differences in facial lipidomics and microbiomics between patients' lesion sites and the healthy population, as well as before and after the use of creams by patients to see whether the lipidomics and microbiomics at skin lesions are different in PAE patients compared to the healthy population and whether the intensive care cream has an improved effect on them.

Facial Skin Microbiome in Patients With Moderate-to-Severe Acne Vulgaris Treated With Isotretinoin

Acne vulgaris is associated with changes in the facial skin microbiome, but longitudinal microbiome changes during isotretinoin therapy remain incompletely understood. This prospective observational cohort study aims to characterize the facial skin microbiome in patients with moderate-to-severe acne vulgaris before and during isotretinoin treatment and to compare microbiome profiles with healthy individuals. Participants with moderate-to-severe acne vulgaris receiving standard-of-care oral isotretinoin will be followed prospectively. Facial skin swab samples will be collected before treatment and at scheduled follow-up visits during therapy. Healthy volunteers without acne will provide a single facial skin swab for comparison. Bacterial communities will be analyzed using 16S rRNA gene sequencing, and clinical severity will be assessed using validated acne severity scores and lesion counts. The study will evaluate changes in microbial diversity, bacterial composition, and the relative abundance of acne-associated microorganisms during isotretinoin treatment. Associations between microbiome changes and clinical improvement will also be explored. Results are expected to improve understanding of the role of the skin microbiome in acne and provide evidence for future microbiome-based therapeutic strategies.

Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults

The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) for the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for moderate to severe Acne vulgaris.

Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients

In Dermatology, assessment of people of color remains underrepresented in RCTs (\<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in mild acne and isotretinoin in severe acne. In darker skin type patients, i.e., Fitzpatrick phototypes IV-VI, acne-related pigmentation (ARP) occurs in 65% of cases which reflects either per- or post-inflammatory hyperpigmentation. Whatever is the mechanism, ARP (number, size, importance of dyschromia) impacts the quality of life in such patients. In moderate acne, treatment is based on oral antibiotics for 3 months, i.e., doxycycline or lymecycline, with topical treatment like tretinoin targeting comedons (and potentially ARP). However, oral antibiotics first-line were developed in white skin patients only and never showed its efficacy in ARP. Moreover, doxycycline could be associated with new-onset hyperpigmentation in acne patients. Isotretinoin -acting on the sebaceous gland and therefore the most effective drug in acne- is only prescribed after failure of antibiotics according to the guidelines.The main objective: To assess the superiority at M6 of a treatment of moderate facial acne in skin of color patients with oral isotretinoin in first line compared to the current standard of care on the severity of ARP.Multicenter randomized controlled trial - open study. The number of subjects required for the trial = 420

Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris

This Phase III randomized, double-blind, placebo-controlled, adaptive, multicenter study evaluates the efficacy and safety of a new concentration of the fixed-dose combination EF190 in women with moderate acne vulgaris over six 28-day treatment cycles. Eligible participants will be randomized (2:1) to receive either the experimental drug or placebo alongside standard skincare. The study includes five in-person visits (screening, randomization, and three follow-ups) and three phone contacts (cycles 2, 4, and 5) to monitor adherence, adverse events, and contraceptive use. A subgroup will undergo additional exploratory assessments, including acne questionnaires, ovarian activity tests, photographic documentation, and specialized lab/ultrasound exams.

A Long-term Safety and Efficacy Study of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Subjects With Acne Vulgaris (GEDACNE-LT)

The clinical trial aims to test the long term safety of a new drug for acne vulgaris. The trial is performed to answer this question "Is it safe to apply the IMP daily for up to 52 weeks?". The trial aims to accurately measure the safety and the effects of the new treatment (N-Acetyl-GED-0507-34-LEVO gel 5%) and to achieve this, patients will be review the drug containing the active ingredient. Participants will: * Take drug every day for up to 52 weeks * Visit the site once every 4 weeks for checkups and tests (where applicable) for the first 3 months of treatment, then visit the site every 13 weeks approximately for checkups and tests (where applicable). * Record on a diary the daily/weekly applications of the study drug at home, and record any adverse events

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

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

A Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5% in Patients With Acne Vulgaris (GEDACNE 2)

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

Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.

Acne vulgaris of adult woman has increased over the past 10 years; it affects currently 20% to 30% of adult women. The physiopathology of adult woman acne is distinguished from the teenager one by essentially 2 factors: * hormonal factor with a peripheral hyperandrogenism coupled with an hypersensibility of cutaneous androgens receptors of these women. But this point is still at the stage of hypothesis. * inflammatory factor linked with Propionibacterium Aces ; indeed these women received most of the time many cures of local and systematic antibiotics at the origin of resistant Propionibacterium Aces strains which lead to a chronical activation of cutaneous innate immunity. On a therapeutic plan, four types of systemic treatment, approved in this indication are: * Tetracyclines which are problematic for the bacterial resistance and consequently constant relapse when they are stopped. * Zinc salts which target only the inflammatory lesions and were shown less effective than cycline * Antiandrogens, with acetate of cyproterone associated with risks of phlebitis and pulmonary embolism, and increase risk of triglycerides, cholesterol and hepatic balance. * The last alternative is represented by isotretinoin but the use in women of childbearing potential is binding because of the teratogen risks and the hyperandrogenism represents an identified risk of relapse. In this context, the spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at sebaceous gland and inhibits Luteinizing hormone (LH) production at the pituitary level. It is not submitted to isotretinoin constraints, does not lead to bacterial resistance and targets the peripheral hyperandrogenism. Currently, very few studies have been performed and on a weak number of patients but they showed that at low doses (lower than 200mg/day), spironolactone can be effective against acne. In that context, it seemed clearly interesting to perform the first double-blind randomized study spironolactone vs cyclines which remains the moderate acne reference treatment and to demonstrate the superiority of spironolactone's efficacy in order to establish it as alternative way to cycline.

The Impact of Baseline Hormonal Profiles (DHEAS, FSH, LH) on Treatment Response to Systemic Isotretinoin in Adult Female Patients With Acne Vulgaris

Acne vulgaris is a common dermatological condition in adult women, often influenced by hormonal factors. Androgens such as dehydroepiandrosterone sulfate (DHEAS) can stimulate sebaceous gland activity, while gonadotropins (FSH and LH) reflect ovarian and hypothalamic-pituitary axis function. Although systemic isotretinoin is highly effective in severe or treatment-resistant acne, variability in treatment response has been observed among female patients. The role of baseline hormonal levels in predicting isotretinoin response remains unclear. Identifying hormonal predictors of treatment response may improve patient stratification and personalized management. Aim of the study is to evaluate whether baseline serum levels of DHEAS, FSH, and LH are associated with clinical response to systemic isotretinoin in women aged 18 years and older with acne vulgaris.

Effect of Oral Isotretinoin on Ocular Surface and Meibomian Glands

The aim of the study was to evaluate meibomian gland morphology using non-contact meibography and ocular surface changes in patients with acne vulgaris treated with isotretinoin as indicators of dry eye, which is known to be a side effect of isotretinoin.

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

The goal of this observational study is to learn about the effects of a treatment that contains clindamycin phosphate, adapalene, and benzoyl peroxide in people with acne. The main questions the study aims to answer are: * How satisfied are people with this treatment? * How well do people follow the treatment plan? * How effective and safe is the treatment? * How does the treatment affect quality of life? * How do people use other skin care products, such as cleansers, moisturizers, and sunscreen, while using this treatment? About 200 people aged 12 and older with acne across Canada will use the treatment as part of their regular care and answer questions about their experience over 20 weeks.

Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris

This clinical study will compare a radiofrequency (RF) treatment with a standard topical treatment for adults with mild-to-moderate inflammatory facial acne vulgaris. Approximately 60 participants will be randomly assigned to one of two treatment groups. Participants in the RF group will receive three treatment sessions using the Density Noir radiofrequency system at 6-week intervals. Participants in the topical treatment group will use a combination gel containing adapalene 0.1% and benzoyl peroxide 2.5% once daily for 12 weeks. Participants in both groups will be followed for an additional 12 weeks after completion of treatment. The main purpose of the study is to compare how well the two treatments reduce the number of inflammatory acne lesions and facial sebum production. The study will also evaluate treatment safety and tolerability. Additional assessments will include overall acne severity, skin redness, dermal thickness, quality of life, treatment-related pain, participant satisfaction, and durability of treatment response.

Microneedling With Glycolic Acid or Trichloroacetic Acid for Atrophic Acne Scars

Atrophic acne scars are depressed scars that can remain after acne has healed. Microneedling is a procedure that uses very small needles to create controlled micro-injuries in the skin, which may stimulate collagen production and improve scar appearance. Chemical peels, including glycolic acid and trichloroacetic acid, may also improve acne scars. This study compares three approaches for treating atrophic acne scars: microneedling followed by a 35% glycolic acid peel, microneedling followed by a 15% trichloroacetic acid peel, and microneedling alone. Sixty adults with atrophic acne scars are randomly assigned to one of the three groups. Participants receive a series of microneedling treatments at 2-week intervals. The study evaluates changes in scar severity, participant satisfaction, treatment-related pain, recovery time after treatment, and side effects. The findings may help identify whether adding either chemical peel to microneedling provides greater benefit than microneedling alone and whether one combination has a shorter recovery time or fewer side effects.

A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris

The primary objective is to assess the efficacy of trifarotene 50 microgram per gram (mcg/g) cream versus vehicle cream when applied once daily (QD) for 12 weeks in Chinese participants with moderate facial and truncal acne vulgaris.

Adjunctive 308-nm Excimer Light With Oral Azithromycin for Inflammatory Acne

This randomized, evaluator-blinded, split-face study evaluated whether adjunctive lesion-directed 308-nm excimer light improves inflammatory acne outcomes during oral azithromycin therapy. All participants received oral azithromycin 500 mg three times weekly for 8 weeks. One randomly allocated hemiface additionally received 308-nm excimer light twice weekly for 8 weeks, while the contralateral hemiface served as the azithromycin-only control. Papule and pustule counts and hemiface Investigator's Global Assessment were assessed through Week 8. Investigator's Global Assessment was reassessed at Week 16 after an 8-week treatment-free follow-up. We hypothesized that the excimer-treated hemiface would demonstrate greater reduction in total inflammatory-lesion count by Week 8.

A Clinical In-Use Evaluation to Assess the Tolerability and Efficacy of a Moisturizer on Acne Prone Skin

The objective of this study is to evaluate the tolerance and efficacy of a facial moisturizer in subjects with mild to moderate acne vulgaris over a 4-week treatment period.

Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo

This study is to evaluate the safety, pharmacokinetics, and treatment effect for topically applied CABTREO lotion in pediatric participants ages 9 to 11 years, 11 months with Acne Vulgaris.

Comparison of Topical Clascoterone and Adapalene for Mild Acne Vulgaris

There is no local data available regarding the comparative efficacy of topical clascoterone and topical adapalene, particularly in patients with mild acne vulgaris. The findings of this study will help dermatologists identify the more effective topical treatment for mild acne vulgaris, leading to improved patient outcomes and better utilization of healthcare resources. Furthermore, the study will contribute local data to the existing literature and may assist in developing evidence-based treatment recommendations for patients with mild acne vulgaris in our setting. Patients meeting the inclusion criteria from the Dermatology Unit, Khyber Teaching Hospital, MTI, Peshawar will be incorporated into the study following approval from the ethics committee. At the commencement of the trial, baseline demographics including gender, age, height, weight, BMI, duration of acne, socioeconomic status, profession, monthly income, education level and residential status will be documented. An elaborate explanation of the process involved in the study will be provided to the participants, and consent will be taken following an explanation of the pros and cons involved. Randomization will be performed by computer generated random list. The group assignments will be put into sealed envelopes, which will be opened when the patient will be included in study. 30 patients will be in topical clascoterone group (A) while 30 patients will be in topical adapalene group (B). Patients allocated to Group A will receive topical clascoterone 1% cream. It is required that they will clean their faces using a mild cleansing agent, dry their faces and thereafter apply a thin coating of clascoterone 1% cream to their whole face area in the morning and evening for 12 consecutive weeks. Patients allocated to Group B will receive topical adapalene 0.1% gel. Patients will cleanse the skin using a gentle cleanser, allow it to dry in the air for 10 minutes, and then apply one pea-sized amount of 0.1% adapalene gel over their entire affected area of the face once a day before going to bed for 12 weeks.

AI-Generated Acne Vulgaris Learning Material Study

This comparative educational intervention study evaluated the educational effectiveness of artificial intelligence-generated patient information material on acne vulgaris among early-year medical students. In the first phase, acne vulgaris information texts were generated using different artificial intelligence models and evaluated by two dermatologists using quality and understandability assessment tools. In the second phase, the best-performing artificial intelligence-generated material was compared with standard human-generated material from the Turkish Dermatology Association and a control group. A total of 190 first- and second-year medical students at Erciyes University Faculty of Medicine participated in the study. Participants were divided into three groups: artificial intelligence-generated material group, Turkish Dermatology Association material group, and control group. After the educational materials were presented, participants completed a 12-question knowledge assessment questionnaire on acne vulgaris.

Low-Dose Versus Conventional-Dose Oral Isotretinoin for Acne Vulgaris

Background and Purpose: Acne vulgaris is a common skin condition that can cause significant physical and emotional distress. Oral isotretinoin is a highly effective treatment for severe or persistent acne. While the standard (conventional) dose is effective, it is often associated with side effects like dry skin, chapped lips, and altered labs. The purpose of this study is to compare a lower daily dose of oral isotretinoin against the conventional daily dose in individuals with acne vulgaris. What the Study Aims to Find Out: Researchers want to determine if a low-dose regimen can match the effectiveness (efficacy) of the conventional dose while reducing the frequency and severity of side effects (safety). Study Design: Participants will be randomly assigned to receive either the low-dose oral isotretinoin or the conventional-dose oral isotretinoin. Researchers will monitor and compare acne clearance rates, patient satisfaction, and any side effects experienced by the participants throughout the treatment period.

Laser Treatment of Moderate to Severe Acne Vulgaris

The goal of this clinical trial is to learn if fractional ablative laser can treat active acne vulgaris in adults 18 to 40 years old with moderate to severe acne vulgaris. The main questions it aims to answer are: Does ablative fractional carbon dioxide treatment effectively treat moderate to severe active nodular acne vulgaris? Does ablative fractional carbon dioxide treatment effectively treat moderate to severe active nodular acne vulgaris over a short time frame? Is non-selective laser useful in treating inflammatory skin disease? How does the microbiome change after laser treatment? Participants will... * Receive up to 3 laser treatments * Attend a baseline visit and follow-up visits post-treatment where participants will receive a clinical assessment, facial swab, and facial-imaging