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Keratosis, Actinic clinical trials

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NCT ID: NCT06026358 Withdrawn - Actinic Keratoses Clinical Trials

Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands

Start date: October 2023
Phase: Phase 4
Study type: Interventional

Interventional, monocentric, national, internal placebo-controlled, prospective pilot study, consisting of two parts, A (single-blinded) and B (open) to assess Efficacy of Tirbanibulin for the treatment of AK on the back of the hand. In part A, eligible subjects receive Tirbanibulin on the left hand and placebo on the right hand for 5 d in a single-blinded manner. Safety and efficacy are assessed at day 8 (± 1 d) (3 days after the end of treatment (EoT+3) and day 57 (± 7 d) after the start of the treatment. Pictures will be taken at baseline, 8 d and 57 d (± 7 d) as per protocol and optional during unscheduled visits.

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: NCT06008171 Recruiting - Actinic Keratoses Clinical Trials

Patient Decision Aid for the Treatment of Actinic Keratosis

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

This study evaluates whether a Patient Decision Aid for the field-directed treatment of actinic keratosis has an effect on shared decision making and patient satisfaction.

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: NCT05942794 Recruiting - Oral Cancer Clinical Trials

Identification of Oral Lesions Through an Autofluorescence System

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

The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa. The screening process will be performed by 3 clinicians with a different level of experience. Sensitivity and specificity tests will be conducted.

NCT ID: NCT05937529 Completed - Actinic Keratoses Clinical Trials

Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis

Start date: September 27, 2023
Phase: N/A
Study type: Interventional

Premalignant AKs are highly frequent in the light-skinned populations with an increasing incidence. PDT is considered a well-establish treatment for these lesions, and therefore it is essential to achieve an optimal and effective treatment as possible. The present study proposes a new post-treatment modality with application of an anti-inflammatory moisturizer Cicaplast Baume B5+ to the treated areas that may improve the overall patient satisfaction and minimize the local skin reactions. Treatment regime consists of two daily applications of Cicaplast Baume B5+ for 14 days, and this regime is not associated with increased risk of systemic AEs or serious events.

NCT ID: NCT05923060 Not yet recruiting - Actinic Keratoses Clinical Trials

Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses

Start date: October 2024
Phase: Phase 2
Study type: Interventional

The purpose of the study is to test a new video device for actinic keratoses. The device takes images of your skin lesions during the treatment, to learn whether this device can predict how well the treatment is working.

NCT ID: NCT05900258 Completed - Actinic Keratosis Clinical Trials

Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

SunDamage
Start date: May 11, 2023
Phase: Phase 4
Study type: Interventional

Interventional, monocentric, national, single-arm, uncontrolled, open, prospective phase IV study. Since this study is not powered for confirmative testing, analysis is done by descriptive statistics Eligible AK patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC. Diagnosis and monitoring of treatment effects are supported by UV imaging using Canfield VISIA®. Safety and efficacy are assessed at end of treatment visit (EoT, approximately 3 days after the last dose, i.e, day 8 ± 2) and at a follow-up visit (FuV) 57 ± 7 d after the start of the treatment. UV images (Canfield VISIA®) will be taken at baseline, EoT and FuV, accompanied by conventional dermatological assessment according to clinical routine.