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Keratosis, Actinic clinical trials

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NCT ID: NCT06461442 Enrolling by invitation - Actinic Keratoses Clinical Trials

Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis

Start date: July 1, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare the effectiveness and safety of two treatments-cryotherapy and 5-Fluorouracil (5-FU)-for actinic keratosis, a common skin condition caused by long-term sun exposure. Cryotherapy is a treatment that uses extreme cold produced by liquid nitrogen to freeze and destroy abnormal cells, and 5-FU is a topical cream applied to the skin to treat lesions by interfering with cell growth. The main questions this trial aims to answer are: - Which treatment, cryotherapy or 5-FU, is more effective in reducing the number of actinic keratosis lesions? - What are the side effects associated with each treatment? - How do these treatments impact patient satisfaction, cosmetic outcomes, and health-related quality of life? Participants will: - Undergo a baseline assessment where their demographics information such as age, sex, race, smoking status, and medical history are recorded, along with the number and severity of actinic keratosis lesions. - Receive both cryotherapy and 5-FU, with each treatment applied to different areas of their body. The area of the body to receive each treatment is decided by a random process (like flipping a coin). - Complete weekly surveys to monitor for side effects during and after the treatment period. - Return to the clinic for follow-up assessments at 3 months and 12 months.

NCT ID: NCT06428721 Recruiting - Aging Clinical Trials

The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population

Start date: March 20, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.

NCT ID: NCT06385340 Not yet recruiting - Actinic Keratoses Clinical Trials

Investigation of the Effect of Lipikar Baume AP+M

Start date: April 23, 2024
Phase: N/A
Study type: Interventional

Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms. It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria. A total of 20 subjects will be enrolled. The study design consists in 4-week evaluation period, with 2 visits per subject: Screening/Baseline (Day 0, Day 28 (end of Lipikar Baume AP+M application)).

NCT ID: NCT06321003 Recruiting - Oral Cancer Clinical Trials

SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

SYMILIS OCT
Start date: March 13, 2024
Phase:
Study type: Observational

This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features. The trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC. Furthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods. In summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice.

NCT ID: NCT06319794 Recruiting - Actinic Keratosis Clinical Trials

Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis

Start date: April 2, 2024
Phase: Phase 2
Study type: Interventional

The aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis (AK) on the face and/or scalp and/or back of hands

NCT ID: NCT06274320 Recruiting - Actinic Keratoses Clinical Trials

Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment

Start date: April 5, 2024
Phase: N/A
Study type: Interventional

This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment.

NCT ID: NCT06135415 Recruiting - Keratosis, Actinic Clinical Trials

A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis

TirbAKare
Start date: December 21, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of tirbanibulin 10 milligrams per gram (mg/g) ointment when applied to a treatment field (TF) larger than 25 centimeter square (cm^2) and up to 100 cm^2 in adult participants with actinic keratosis (AK).

NCT ID: NCT06108024 Recruiting - Clinical trials for Seborrheic Keratosis

A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis

Start date: November 6, 2023
Phase: Phase 2
Study type: Interventional

The objective of the trial is to evaluate the safety and efficacy of SM-020 gel 1.0% in subjects with Seborrheic Keratosis (SK) compared to vehicle gel. It is a randomized, double-blind, vehicle-controlled trial. Approximately 60 subjects will be enrolled. Subjects will apply their assigned investigational product twice daily for 4 consecutive weeks. Subjects will be followed for 12-weeks post final application for a total of approximately 16-weeks of required participation in the study.

NCT ID: NCT06032078 Active, not recruiting - Keratosis Pilaris Clinical Trials

Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris

Start date: July 26, 2023
Phase: N/A
Study type: Interventional

This prospective study aims to evaluate the responsiveness of the validated investigator global assessment (IGA) and composite area index score for keratosis pilaris by data collection through treatment and scoring sessions held at a private practice and relevant statistical analysis.

NCT ID: NCT06027619 Recruiting - Actinic Keratosis Clinical Trials

Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses

Start date: October 2, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that patients sometimes experience during conventional PDT treatment. The main questions it aims to answer are: - Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion, still achieve significant inflammation and lesion clearance? - Will shortened incubation times of Ameluz still achieve significant inflammation and lesion clearance? - Will the new test regimens achieve reduced pain during illumination? - Will the new test regimens be safe? Participants will be randomly assigned to one of three treatment regimens, which will determine the length of time that the topical medication will incubate on the face before red light exposure in PDT treatments. The incubation period will be either 10 minutes, 20 minutes, or 60 minutes.