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Keratosis, Actinic clinical trials

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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: NCT06014697 Active, not recruiting - Diagnosis Clinical Trials

OCT and Invasion in Cutaneous Skin Lesions

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

The increasing incidence of actinic keratosis (AK), morbus Bowen (MB) and cutaneous squamous cell carcinoma (cSCC), the patients with often multiple lesions and the disadvantages of invasive diagnostics show the need for an accurate non-invasive diagnostic tool for the determination of invasive growth in AK and MB. Optical coherence tomography (OCT) is a non-invasive scanner creating cross-sectional images of the skin, to a depth of 1-1,5 mm based on light waves. Until now, OCT has been proposed as non-invasive diagnostic tool for basal cell carcinomas. Although the diagnostic value of OCT for detection and sub-typing of basal cell carcinomas has already been demonstrated, it is unclear whether OCT can discriminate between invasive and non-invasive lesions (AK, MB and cSCCs). There are some studies that describe OCT characteristics of AK, MB and cSCCs, however, these characteristics have a lot of overlap (8-13). To date there are no clearly distinctive OCT features to distinguish between AK, MB and cSCCs. This study aims to investigate the value of OCT in discriminating between the presence and absence of invasion in lesions with clinical suspicion for invasion. Two experienced OCT-assessors will evaluate the OCT scans independently. The OCT assessors are blinded to the histological diagnosis of the lesions (invasive or non-invasive), which is used as golden standard. A 5-point Likert scale is used for OCT assessment. 1. Definitely not invasive 2. Probably not invasive 3. Unknown, probably invasive/probably not invasive 4. Probably invasive 5. Definitely invasive In addition to completing the Likert-scale, assessors are asked to describe the presence/absence of predefined OCT characteristics (a.o. hyperkeratosis and the presence of the dermo-epidermal junction) In case of disagreement between the independent assessors, the OCT scan will be re-assessed in a consensus meeting.

NCT ID: NCT05987553 Active, not recruiting - Actinic Keratoses Clinical Trials

The Influence of an E-learning Program on Recognition of Actinic Keratosis

Start date: January 1, 2021
Phase:
Study type: Observational

The evaluation on the diagnostic accuracy of actinic keratosis recognition by general practitioners before and after participation on an e-learning program.

NCT ID: NCT05976061 Active, not recruiting - Actinic Keratoses Clinical Trials

High- and Low-risk Actinic Keratosis Referrals to Secondary Care

Start date: March 1, 2021
Phase:
Study type: Observational

This study evaluates the implementation of the General Practitioners guidelines 'Suspicious Skin Lesions' and investigated whether their publication and implementation has led to a reduction in the proportion of referrals of low-risk patients with actinic keratosis to secondary care, after publication of the General Practitioners guidelines and implementation activities.

NCT ID: NCT05976048 Active, not recruiting - Actinic Keratoses Clinical Trials

Implementation of Actinic Keratosis Guideline Among General Practitioners.

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

This study investigates 5-fluorouracil cream prescription trends by general practitioners for the treatment of field changes of actinic keratosis over the years 2016-2021. The aim is to analyse whether the publication of the multidisciplinary guideline on suspect skin lesions for general practitioners in 2017 has made an impact in the prescribing behaviour of general practitioners.

NCT ID: NCT05456334 Active, not recruiting - Actinic Keratoses Clinical Trials

New Treatments for Actinic Keratoses of the Scalp

Start date: March 24, 2016
Phase: N/A
Study type: Interventional

This blinded controlled 2-year study on 120 patients with 2 or more actinic keratoses, compare the efficacy and tolerability of pulsed dye-laser- mediated photodynamic therapy compared to conventional photodynamic therapy and fractional-laser assisted daylight photodynamic therapy compared to daylight photodynamic therapy.

NCT ID: NCT05202860 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma

Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients With Actinic Keratosis

VAXAK
Start date: May 9, 2022
Phase: Phase 2
Study type: Interventional

A double-blind, randomized, placebo controlled intervention trial on patients with actinic keratosis.

NCT ID: NCT05164393 Active, not recruiting - Actinic Keratoses Clinical Trials

Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK

COAKS
Start date: November 2, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Actinic keratosis (AK), also known as solar keratosis, is a common skin condition characterised by abnormal growth of skin cells caused by long-term sun exposure. AK is considered to be a precancerous lesion, and is therefore commonly treated to reduce the risk of malignant transformation into skin cancer. The trial is a randomised, double-blind, vehicle-controlled, dose-comparison trial in which adult subjects with AK grade 1 or 2 will be treated with AVX001 silicone-based gel in doses of 1% or 3% or with a gel vehicle for a 4-week field-directed treatment period. Subjects will be followed up for 8 weeks after the treatment period. The primary objective is to evaluate the local tolerability of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle.

NCT ID: NCT05136144 Active, not recruiting - Clinical trials for Seborrheic Keratosis

Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis

Start date: October 19, 2021
Phase: Phase 2
Study type: Interventional

This is a first-in-humans adaptive design open label trial to explore the safety and efficacy of SM-020. Multiple dosing cohorts will be enrolled. The first cohort will have a two-week treatment period of twice daily applications followed by a four-week follow-up period. Based on the results at any time from the first and subsequent cohorts, additional cohorts will explore different dosing regimens.

NCT ID: NCT04809662 Active, not recruiting - Actinic Keratoses Clinical Trials

Comparing Immune Responses to Topical Imiquimod

Start date: March 16, 2021
Phase:
Study type: Observational

The study is a basic science research study that is designed to characterize and compare the immune response in individuals who are designated as ABO blood group secretors, meaning they have a functional copy of the FUT2 gene versus those patients who are designated ABO non-secretors after application of topical imiquimod to these patients.