Clinical Research Directory

Topical Application of Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne

A growing body of evidence suggests that the development and progression of acne are closely linked to an imbalance in the skin's microbial community. Compared to healthy skin, the composition and function of the microbiota in acne lesions are significantly altered. This microbial imbalance is believed to drive the formation and recurrence of acne through mechanisms such as triggering abnormal inflammatory responses and compromising the skin barrier. An in-depth exploration of the interaction between acne and the skin microbiome not only offers new perspectives for understanding the root causes of the disease but also lays the groundwork for developing novel treatment strategies aimed at modulating the microbiota. Therefore, identifying innovative approaches that integrate acne treatment with the regulation of microbial balance holds significant clinical and social value. Although existing acne treatments have made progress, research focusing on interventions that regulate the local skin microecology through probiotics remains relatively limited. This study aims to explore a new strategy based on skin microecological modulation. Investigators are using a common probiotic-Lactobacillus reuteri-and applying an engineering modification with a special coating formed by zinc sulfate and tannic acid (MPN coating). This modification is intended to enhance the bacterium's survival and colonization on the skin, thereby more effectively regulating the local microbiota and reducing inflammation. This study is a rigorous scientific clinical trial designed as randomized, double-blind, and controlled. Eligible participants will be randomly assigned to one of four groups, receiving either the engineered Lactobacillus reuteri cream, the plain Lactobacillus reuteri cream, a simple moisturizing cream (placebo), or an already-marketed effective cream (tretinoin cream). The treatment will last for 2 weeks, followed by an 8-week observation period. Efficacy and safety will be evaluated through professional assessments. Our goal is to scientifically evaluate the safety and efficacy of this new therapy, hoping to provide a potential new treatment option for individuals with acne and explore new pathways for improving skin health.

Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers

The purpose of the study is to collect different samples for molecular characterization of inflammatory skin diseases.

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Acne is common illness of adolescents and young adults which is associated with substantial morbidity. While topical treatments are often sufficient for mild acne, moderate to severe acne often requires treatment with systemic medications such as oral antibiotics, hormonal therapies such spironolactone, and isotretinoin. Sebum overproduction is fundamental to the pathogenesis of acne with associated disordered keratinization and subsequent microbial colonization and inflammation resulting in the clinical manifestations of acne. Given the influence of hormones on sebum production, therapies that address these underlying hormonal factors such as spironolactone and oral contraceptive pills represent an underutilized treatment option for women with acne and could help decrease the use of long-term oral antibiotics in this patient population. The purpose of this trial is to evaluate the comparative effectiveness of spironolactone versus doxycycline hyclate (tetracycline class antibiotic) for women with acne.

Non-interventional Translational Study in Mild, Moderate and Severe Acne Patients

This study aims to uncover the specific immunopathology, microbiome and pathophysiology of acne vulgaris in people living in a tropical climate such as Singapore. This is a largely unexplored population in terms of acne pathogenesis, and will lead to population-specific interventions for the management of acne vulgaris.

Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne

This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of TVB-3567 administered orally in healthy participants. Part B will be a randomized, open-label, 2-way crossover investigation to assess the effect of food on a single dose TVB-3567 administered orally in healthy participants. Parts C and D will be randomized, double-blind, placebo-controlled investigations of multiple ascending doses (MAD) to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants without and with moderate to severe acne, respectively.

The Suitability of Tience® for Treating Acne Scars

This is an open-label, single-center, split-face, pseudo-randomized clinical trial designed to evaluate the efficacy and safety of a human-derived, cell-free adipose tissue derivative (Tience® ), for treating moderate to severe acne scars. Participants will receive three treatment sessions over a three-month period: on Day 0, Day 30, and Day 90. Treatment will be administered via injections to acne-scarred areas on one side of the face. The untreated side will be treated after the follow-up period. Outcomes will be evaluated over a twelve-month period using investigator clinical assessments, patient self-evaluation and VISIA skin analysis system to monitor changes in scar severity and overall skin quality.

Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adults Subjects With Facial Acne.

The aim of this study is to evaluate the efficacy of the RV3278B-OS0386 cosmetic product, compared to the control product in managing acne relapse during the 12-month maintenance phase follow-up after oral isotretinoin treatment in adult subjects with facial acne.

Experience With Topical Acne Treatment

Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. Primary nonadherence refers to problems acquiring and starting treatment. Challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 Secondary nonadherence refers to when the patient does not use the medication as prescribed. Hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2

Expert Consensus on the Use of Isotretinoin in Acne Vulgaris: A Delphi Study

This study is a Delphi-based expert consensus project designed to establish evidence-informed, practical recommendations for the use of isotretinoin in acne vulgaris. Despite isotretinoin being the most effective therapy for severe and refractory acne, variations persist in its indications, dosing strategies, monitoring protocols, and safety counseling.

A Clinical Trial to Investigate the Efficacy and Safety of GenLabs' Social Skin on Improving Acne Symptoms and Skin Repair Among Healthy Adults

The goal of this interventional clinical trial is to investigate the efficacy and safety of GenLabs' Social Skin on improving acne symptoms and skin repair among healthy adults. The main question\[s\] it aims to answer is: What is the difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Skin and placebo from baseline at Day 30.

Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to three dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE). The Core Study will consist of a Sentinel Cohort A paired with a Main Cohort, evaluating the safety and efficacy of the 2-administration regimen and a Sentinel Cohort B, evaluating the safety of the 3- administration regimen. The Sentinel Cohorts will assess the safety of the dose levels and regimens in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long-term effects of the vaccine.

Assessment of the Efficacy of Topical Ketoconazole 2% Cream in Comparison With Topical Retinoids in the Treatment of Mild Comedonal and Papulopustular Acne

objective: is to assess the efficacy of topical ketoconazole 2% cream in comparison with topical retinoid in the treatment of mild comedonal and papulopustular acne to determine if ketoconazole can be an alternative to topical retinoid with less side effects and more compliance. Patients and methods: 52 patients with mild comedonal and papulopustular acne will be randomized into 2 groups and instructed to apply randomly either topical KTZ 2% cream or topical retinoid cream for a period of 12 weeks. Evaluation of response will be done by a blinded investigator

Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne

The purpose of the VBE00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the Acne mRNA vaccine candidate at single dose level in participants aged 18 to 45 years with mild acne. This study will consist of a Core Study followed by an optional Long-Term Extension (LTE). Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long term effects of the vaccine.

Clinical Study to Evaluate the Safety and Efficacy of Candela Technology

This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.

PMCF Investigation of Medical Device ChitoCare® Medical

This is a post-marketing observational clinical investigation conducted as part of the post-market clinical follow-up of ChitoCare® Medical, aimed to confirm safety and efficacy according to the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, for the following indications: Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne Spray - conditions after dermatosurgical procedures, dermatitis, acne

Photodynamic Therapy With Topical Application of a Zn(II) Phthalocyanine (RLP068/Cl) and Red Light for the Treatment of Moderate-to-severe Acne Vulgaris

This pilot clinical study will evaluate the safety, tolerability, and effectiveness of a novel photodynamic therapy (PDT) for moderate-to-severe acne vulgaris. PDT combines a topical photosensitizing gel with red light to treat acne lesions. The gel to be used in this study, called RLP068/Cl (a zinc phthalocyanine compound), has demonstrated antimicrobial, anti-inflammatory, and sebosuppressive effects in laboratory studies. A total of 10 patients with moderate-to-severe acne on the face will be enrolled. RLP068/Cl 0.3% gel will be applied topically for 30 minutes under occlusion, followed by 8 minutes of red LED light exposure. Treatments will be performed twice weekly, with the total number of sessions individualized based on clinical response. Acne severity will be assessed using the Global Acne Grading System (GAGS). Pain levels will be recorded after each session using a visual scale, and patient satisfaction will be evaluated at the end of the treatment cycle. The goal of the study is to determine whether RLP068/Cl-PDT is a safe, well-tolerated, and effective non-antibiotic treatment option for patients with moderate-to-severe acne vulgaris who may not respond to or tolerate conventional therapies.

An Observational Clinical Study to Evaluate the Efficacy of the CeraVe Skin Care Line

This is an observational clinical study to evaluate the efficacy of the CeraVe Skin Care product line in improving mild to severe facial acne. Primary Objective: To evaluate the efficacy of CeraVe Skincare products in improving mild to severe facial acne through clinical observation by dermatologists of skin conditions before and after the use of the test product kit during the course of acne medication, as well as to collect concurrent feedback on the quality of life of this population and their experience with and satisfaction with the test product. Secondary objectives: 1. To collect feedback on the experience, satisfaction and quality of life improvement of CeraVe products through subjective evaluation of the subjects after using the products, in order to gain a deeper understanding of the comprehensive performance of the products in actual application; 2. To verify the tolerance of CeraVe products through clinical evaluation of the facial skin condition before and after the use of the products by dermatologists; 3. To evaluate the effectiveness of CeraVe products in improving acne. CeraVe is a dermatologist's clinical assessment of facial skin conditions before and after use to verify the tolerability and safety of CeraVe's skin care products. The study is designed to enroll approximately 240 male and female study participants aged 13 years or older with mild to severe facial acne, with a minimum sample size of 200 subjects based on a 15% dropout rate during the trial period and a protocol violation rate of no more than 5%. Participants entering the study will be classified as having mild, moderate, or severe acne according to the Global Evaluation Acne Grading Scale (GEA) (mild-grade 1 or grade 2, moderate-grade 3, severe-grade 4 or higher), with a sample size of mild acne:moderate acne:severe acne of approximately 1:1:1. The study was conducted over an 8-week period with 3 visits. They were conducted at the baseline visit (T0), week 4 follow-up (T4w) and week 8 follow-up (T8w). The window period was ±1 day for the week 4 (T4w) visit and ±2 days for the week 8 (T8w) visit. The primary evaluation parameters included: clinical assessment and product tolerance assessment by the dermatologist, patient self-assessment and questionnaires.

Exploring Acne Treatments Through Clinical Research Participation

The purpose of this study is to understand the lived experiences of acne patients enrolled in a related clinical trial testing a particular treatment. The primary focus will be on tracking trial adherence and dropout rates to enhance future research and care approaches, especially for underserved groups.

Emulsion 8-Week Anti-acne Efficacy Clinical Study

65 male and female adult subjects will be enrolled in the study, recruited according to inclusion and non-inclusion criteria listed below, at least 60 subjects should complete questionnaire, at least 40 of them should complete clinical assessment, instrumental measurement and image capture. 20 of them should complete lipid sample collection, and at least 30 of them should complete the RCM captured.

Role of Akkermansia Muciniphila in Acne Vulgaris

The project explores the use of Pendulum's Glucose Control, which contains a unique combination of probiotics, including Akkermansia muciniphila, Clostridium beijerinckii, Anaerobutyricum hallii, Clostridium butyricum, and Bifidobacterium infantis, to treat acne by improving gut health and reducing inflammation. These probiotic strains work synergistically to enhance the gut's protective barrier, lower harmful substances such as lipopolysaccharides, and increase the production of beneficial compounds like short-chain fatty acids, which can help modulate immune response and inflammation associated with acne. By integrating this probiotic combination into treatment strategies, the approach aims to offer a natural and effective solution for clearer skin. Additionally, the project seeks to investigate the correlation between postprandial glucose spikes and acne flare-ups. Continuous glucose monitoring (CGM) will be employed to track blood glucose fluctuations following meals, providing valuable insights into the potential link between metabolic responses and acne severity. This comprehensive approach aims to enhance understanding of how gut health, inflammation, and metabolic factors interact in the context of acne management.

577-nm Diode Laser in the Treatment of Non -Inflammatory Acne

The aim of this study is to evaluate the clinical efficacy and safety of the 577 nm diode laser in the treatment of non -inflammatory acne.

AVAVA MIRIA General Use

A general protocol to treat a variety of dermatologic conditions and collect patient feedback. Primary outcome is the collection and analysis of patient questionnaires related to the overall experience of the device treatment. Secondary outcome measures include physician and subject evaluations in regards to improvement seen in the device as well as assessment of side effects.

Clinical Evaluation and Study of the Efficacy of a Centella Asiatica-Infused Facial Mask on Discosmetic Dermatosis

The purpose of this study was to investigate the efficacy and safety of repairing facial mask containing Asiaticum asiatica in treating disjunctive skin diseases. A multi-center randomized double-blind self-half face control method was used. A computer-generated randomization method was used. Each cheek was randomly assigned to receive the snow glycoside mask and the control group.

A Comparative Study of Cosmetic Product in Subjects With Facial Acne During an Associated-treatment Phase Followed by a Maintenance Phase

In this study, we are interested in the global benefit of the tested product as complementary care to a topical medical treatment during a 3 month-associated treatment phase followed by a 3 month-maintenance phase, compared to a light moisturizing cream, in teenagers and adults with acne. We also want to evaluate the tolerance of the tested product in association and in maintenance of the topical medical treatment.