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Acne Vulgaris clinical trials

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NCT ID: NCT06263413 Recruiting - Acne Vulgaris Clinical Trials

Clinical Workflow Optimization Using Artificial Intelligence for Dermatological Conditions

IDEI_2023
Start date: January 15, 2024
Phase:
Study type: Observational

Artificial intelligence (AI) based on imaging holds tremendous potential to enhance visual diagnostic accuracy in the medical field. Amid the COVID-19 pandemic, limited access to in-person healthcare services drove shifts in medical care, hastening the adoption of telemedicine. In this context, AI usage for triage and decision support may be crucial for professionals to manage workload and improve performance. In dermatology, pigmented lesions, acne, and alopecia are three recurring pathology groups with high demand in dermatological centers. Both triage, clinical evaluation, and patient follow-up require in-person resources and specialist dedication. Employing tools like AI can benefit these professionals in reducing such processes and optimizing workload. Advancements in image recognition and interpretation, as well as in artificial intelligence, have spurred innovations in diagnosing various pathologies, including skin conditions. Computer-Aided Diagnosis (CAD) systems and other algorithm-based technologies have demonstrated the ability to classify lesion images with a competency comparable to that of an expert physician. In this study, the Legit.Health tool, developed by AI LABS GROUP S.L., which utilizes artificial intelligence to optimize clinical flow and patient care processes for skin conditions, will be evaluated. The purpose of this tool is to automatically prioritize patients with greater urgency, assign the type of consultation (dermatological or aesthetic), enhance diagnostic capability and detection of malignant pigmented lesions in auxiliary staff, and provide a visual record (photograph) of the condition for later review by external experts. Thus, the main objective of this study is to validate that Legit.Health, based on Artificial Intelligence, improves efficiency in clinical flow and patient care processes, thereby reducing time and cost of patient care through enhanced diagnostic accuracy and severity determination. The secondary objectives focus on measuring the diagnostic performance of Legit.Health: Demonstrate that Legit.Health enhances healthcare professionals' ability to detect malignant or suspicious pigmented lesions. Demonstrate that Legit.Health improves healthcare professionals' ability and precision in measuring the degree of involvement in patients with female androgenetic alopecia. Demonstrate that Legit.Health improves healthcare professionals' ability and precision in measuring the degree of involvement in patients with acne. Additionally, the study aims to assess the utility of this tool: Automate the triage/initial assessment process in patients presenting with pigmented lesions. Evaluate the reduction in healthcare resources usage by the center by reducing the number of triage consultations and directing the patient directly to the appropriate consultation (esthetic or dermatological). Evaluate Legit.Health's usability by the patient. Demonstrate that Legit.Health increases specialist satisfaction. Evaluate the reduction in healthcare resources usage by reducing the number of triage consultations and directing the patient directly to the appropriate consultation, whether in aesthetic or dermatological settings. Methodology Study Design Type This is an observational study, both prospective with a longitudinal character and retrospective case series. Study Period This study estimates a recruitment period of 3 months. The total study duration is estimated at 6 months, including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing, data analysis, and preparation of the final study report. The total study duration for each participant with pigmented lesions will be 1-3 months. The duration for patients with acne and alopecia will be 1 day. Study Population Adult patients (≥ 18 years) with skin pathologies treated at the Dermatology Unit of IDEI.

NCT ID: NCT06252194 Recruiting - Acne Vulgaris Clinical Trials

Comparative Study of Metformin Versus Doxycycline in Moderate to Severe Adult Acne Vulgaris Patients.

Start date: March 5, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare the effect of doxycycline and metformin in treatment of acne vulgaris patients. The main question is aimed to answer is whether metformin is more effective than doxycycline in treatment of acne vulgaris patient or not. Patients will be asked to take doxycycline along with tropical treatment in one group and metformin along with tropical treatment in another group. Researcher will compare the clinical improvement in two groups.

NCT ID: NCT06248008 Not yet recruiting - Acne Clinical Trials

A Study to Evaluate Safety of ASC40 Tablets in Patients With Moderate to Severe Acne Vulgaris

Start date: April 24, 2024
Phase: Phase 3
Study type: Interventional

This is a multicenter, open-label study designed to determine the long-term safety of ASC40 (Denifanstat) tablets in patients with moderate to severe acne vulgaris enrolled in the ASC40-303 Phase III study. All subjects are eligible for study eligibility screening after enrollment in ASC40-303 Phase III study, and all eligible subjects with moderate to severe acne vulgaris will receive ASC40 (Denifanstat) tablets after signing informed consent. The investigational drug will be administered orally once daily (QD) for up to 40 weeks. There will be a total of 7 visits for screening and follow-up. The tests required by the program included routine blood tests, blood biochemistry, lipid profile, pregnancy test and urine routine, etc.

NCT ID: NCT06242288 Recruiting - Acne Vulgaris Clinical Trials

Correlation Between Depression Scores and Serum NF-ĸB/NLRP3 Axis, Biotinidase, and HMGB After Treatment With Isotretinoin in Patients With Acne Vulgaris

Start date: January 30, 2024
Phase: Phase 3
Study type: Interventional

Acne is a chronic inflammatory disease of the pilosebaceous unit resulting from androgen-induced increased sebum production, altered keratinization, inflammation, and bacterial colonization of hair follicles on the face, neck, chest, and back by, Cutibacterium acnes. Although all age groups can be affected, it is primarily a disease of adolescence. Treatment selection is based on disease severity, patient preference, and tolerability. Isotretinoin is drug of chioce used for moderate and severe acne. Isotretinoin results in a significant reduction in sebum production, influences comedogenesis, lowers surface and ductal c. acnes and has anti-inflammatory properties. Biotin deficiency may be caused by insufficient dietary uptake of biotin, drug- vitamin interactions and increased biotin catabolism during pregnancy and in smokers. Biotin deficiency can also be precipitated by decreased activities of biotinidase, which plays a central role in the intestinal absorption of biotin

NCT ID: NCT06237387 Not yet recruiting - Acne Vulgaris Clinical Trials

Association of Acne Vulgaris With Oral Hygiene and Gingivitis

Start date: June 5, 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about in the relationship between acne vulgaris and oral hygiene and gingivitis. The main questions it aims to answer are: - Is there a relationship between the severity of acne vulgaris lesions and the severity of plaque-related gingivitis? - Could oral hygiene or the severity of plaque-related gingivitis have an impact on the treatment of acne lesions? Participants will; - First be examined at the dermatology clinic. - Then be examined at the periodontology clinic. - Participants with severe acne vulgaris lesions will be examined a second time at the dermatology clinic. (1.5 months after the first examination) - Regularly use the antibiotic containing 100 mg doxycycline prescribed in the dermatology clinic for acne treatment. (Patients deemed suitable by the dermatologist)

NCT ID: NCT06225570 Not yet recruiting - Acne Vulgaris Clinical Trials

Weekly Isotretinoin vs Tetracycline for Moderate Acne

Start date: January 2025
Phase: Early Phase 1
Study type: Interventional

In the effort to find better treatments for Moderate Acne, which often relies on long-term antibiotic use, researchers are exploring alternative options. While Isotretinoin, a Vitamin A derivative, is highly effective for severe acne, its side effects limit its use for milder cases. A recent study from our institution investigated a new approach: weekly Isotretinoin dosing. The results were promising, with acne improvement and no major side effects. This suggests that weekly Isotretinoin could be a successful alternative for moderate acne in both males and females. To validate these findings, investigators propose a randomized controlled trial comparing weekly Isotretinoin to daily Doxycycline over four months. This study could confirm the safety and effectiveness of weekly Isotretinoin, as well as shed light on patient satisfaction, and long-term results compared to standard antibiotics. This research may offer a breakthrough in treating moderate acne while addressing concerns about antibiotic overuse.

NCT ID: NCT06192264 Recruiting - Acne Clinical Trials

A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris

Start date: January 23, 2024
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of ASC40 (Denifanstat) tablets compared to placebo in the treatment of patients with moderate to severe acne vulgaris. The proposed plan for this trial is to enroll subjects who are 18-40 years of age (including borderline values), with a diagnosis of moderate to severe acne vulgaris, and an Investigator's Global Assessment (IGA) graded as moderate (grade 3) or severe (grade 4). 480 subjects were planned to be enrolled in the trial and placebo groups, with all subjects randomly assigned in a 1:1 ratio to receive either ASC40 (denifanstat) tablets dose 1 or placebo, administered orally once daily (taken after dinner) for 12 weeks. There will be a total of 6 visits for screening and follow-up. The tests required by the program included routine blood tests, blood biochemistry, lipid profile, pregnancy test and urine routine, etc..

NCT ID: NCT06186596 Recruiting - Acne Vulgaris Clinical Trials

Self-Administered Intralesional Injections for Acne

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the safety of intralesional injections of triamcinolone self-administered into acne lesions via an injection assistance device. The main question[s] it aims to answer are: - is use of the injection assistance device safe? - is delivery of triamcinolone to acne lesions via the injection assistance device efficacious? Participants will self-inject low dose triamcinolone into acne lesions and track lesion response via photos and survey for 14 days following injection.

NCT ID: NCT06181838 Active, not recruiting - Quality of Life Clinical Trials

Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction

Start date: August 28, 2023
Phase: N/A
Study type: Interventional

This study will compare the quality of life between 2 groups, which are group that receive standard moderate acne therapy in addition of lesion extractions, and the second group which only receive standard moderate acne therapy without lesion extractions.

NCT ID: NCT06179056 Completed - Acne Vulgaris Clinical Trials

Anti-microbial Role of Non-antibiotic Agents Against Cutibacterium Acnes in Patients With Acne Vulgaris

Start date: March 1, 2023
Phase:
Study type: Observational

- To evaluate and compare the anti-biofilm activity of Salicylic acid, Isotretinoin, and N-acetylcysteine against C. acne . - To assess the possible role of Salicylic acid, Isotretinoin, and N-acetylcysteine in improving the susceptibility of C. acne for Azithromycin and Doxycycline.