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Pigmentation Disorders 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: NCT06189768 Completed - Hyperpigmentation Clinical Trials

A Study on Pigmentation Disorders in Children

Start date: January 1, 2020
Phase:
Study type: Observational

The descriptive cross-sectional study was undertaken at Kanti Children's Hospital during the period from January 2020 to June 2021. Ethical approval for the study was obtained from the Institutional Review Board of Kanti Children's Hospital (IRB-KCH). The refence number is 59/2020-021. The study focused on children with hyperpigmentation disorders presenting at the Dermatology Outpatient Department of Kanti Children's Hospital.

NCT ID: NCT06144541 Recruiting - Skin Pigment Clinical Trials

Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type

Start date: November 21, 2023
Phase:
Study type: Observational

The purpose of this study is to correlate subjective skin pigment measurements as reported by patient-responses to the Fitzpatrick Skin Type Scale versus objective classification of skin pigment utilizing Individual Typology Angle (ITA) measurements.

NCT ID: NCT06123572 Completed - Aging Clinical Trials

A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel

Start date: September 14, 2023
Phase: N/A
Study type: Interventional

This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel. Total of 44 adult female subjects (22 Subjects/Arm) of age 35 - 55 years will be enrolled to get 40 completed subjects (20 Subjects/Arm)

NCT ID: NCT06122090 Recruiting - Cicatrix Clinical Trials

Treatment of Hypopigmented Scars With Bimatoprost

Start date: July 18, 2023
Phase: Phase 2
Study type: Interventional

Patients who have hypo-pigmented burn scar will have two scars chosen and randomized to treated scar and control scar. The subject will then have both scars treated with fractional ablative CO2 laser (FLSR). The treated scar will have bimatoprost delivered through the laser channels, while the control will have the vehicle (normal saline) only delivered. The treatment will continue for 14 days with twice daily application. The scars will then be monitored at a 2-week follow-up visit where levels of melanin will be evaluated. Tissue punch biopsies will also be used to evaluate the mechanism of action of bimatoprost. Treatment will occur for 6 sessions at 4-6 week intervals including follow- up visits and evaluations.

NCT ID: NCT06091215 Active, not recruiting - Pigment Skin Clinical Trials

Combining Broad Based Light (BBL), Fractionated 1927 (MOXI) and Dual Wavelength 2940/1470 (HALO)

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery. The study is designed to follow up to 15 consenting subjects who may receive up to 2 BBL/MOXI/HALO treatments under an IRB approved protocol.

NCT ID: NCT06063148 Recruiting - Pulse Oximetry Clinical Trials

Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation

Neo-PODS
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine if pulse oximeters show an SaO2-SpO2 discrepancy that correlates with skin pigmentation such that pulse oximetry will overestimate oxygenation in newborns with darker skin. The main questions it aims to answer is if SaO2-SpO2 discrepancy varies with the degree of skin pigmentation among neonates, if gestational age has an influence on SaO2-SpO2 discrepancy, and if packed red blood cell (PRBC) transfusion has an influence on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin. Researchers will compare SaO2 and SpO2 values in neonates of various skin pigmentation.

NCT ID: NCT05981118 Not yet recruiting - Clinical trials for ICD10 Code L40.9 for Psoriasis

Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant)

Start date: June 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this prospective study is to evaluate the degree of post-inflammatory pigmentation alteration on legs of study subjects treated with two different psoriasis treatments. Betamethasone dipropionate 0.05% cream is a high potency steroid that is commonly used to alleviate the inflammation of psoriasis. Tapinarof is another medication approved for psoriasis; tapinarof activates aryl hydrocarbon receptors to downregulate inflammatory cytokines (such as interleukin [IL]-17) which play a large role in psoriasis. Study subjects will be randomized to receive one of these medications and will be followed to monitor for PIPA. Photographs will be taken to help evaluate visual changes. The Taylor Hyperpigmentation scale will be used to grade the area and severity of hyperpigmentation and hypopigmentation; severity of erythema, burning, peeling, and dryness will also be recorded. This will allow us to understand the effects of two standard-of-care psoriasis medications to better treat patients.

NCT ID: NCT05913102 Active, not recruiting - Pigmentation Clinical Trials

A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin

Start date: September 28, 2022
Phase: N/A
Study type: Interventional

Juvelook® (VAIM, Korea) is made by dissolving irregular PDLLA particles in a solvent mixture of DMSO (Dimethylsulfoxide) and EC (Ethylene Carbonate) and then injecting them through microneedling to create reticulated foamy microspheres, which are hollow spherical particles. It received CE approval in Europe in 2020 and is widely used domestically as a material for tissue restoration, including skin fillers and collagen stimulators. The spherical shape with internal foam structure of PDLLA exhibits excellent biocompatibility, biodegradability, porosity, and mechanical strength. It allows for the control of particle size and acts as a collagen stimulator while gradually dissolving over time. This stimulates fibroblast cells and promotes skin rejuvenation. In clinical practice, Juvelook® particles are injected to address various concerns such as facial wrinkles, increased elasticity, depressed scars, acne scars, accident scars, under-eye hollows, freckles, whitening effects, and neck wrinkles. Therefore, this study aims to investigate the efficacy of Juvelook® not only in volume augmentation but also in improving photoaged skin.

NCT ID: NCT05750914 Completed - Pigmentation Clinical Trials

Evaluation of Broadband Light Treatment for Pigmented Skin Lesions

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Evaluation of safety and efficacy of Broadband light treatment