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Keratosis, Actinic clinical trials

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NCT ID: NCT02600598 Completed - Actinic Keratosis Clinical Trials

Biological Effects of LEO 43204 in Actinic Keratosis

Start date: July 2016
Phase: Phase 1
Study type: Interventional

This is a Phase I, single-centre, open label, within-subject comparison trial to explore the biological effects of LEO 43204 Gel, 0.037%, applied once daily for 3 consecutive days in patients with actinic keratosis on the upper extremity. The treatment area for each patient will be as defined as a contiguous area of 250 cm2 of skin on the upper extremity (including the dorsum manus) that contains a minimum of 5 AK lesions. Additionally there must be at least one AK lesion located in a non-treated area on the contralateral arm. All eligible subjects will receive LEO 43204 Gel, 0.037%, on the treatment area on Days 1, 2 and 3. Study medication application will be (sub)investigator applied. A total of 30 patients will be enrolled into this study (n=15 in each of the two groups). Patients will be divided into two groups with different biopsy schedules.

NCT ID: NCT02594644 Completed - Keratosis, Actinic Clinical Trials

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

Start date: November 6, 2014
Phase: N/A
Study type: Interventional

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

NCT ID: NCT02594436 Completed - Actinic Keratosis Clinical Trials

The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice

PrAKtice
Start date: December 1, 2015
Phase:
Study type: Observational

This is a prospective, non-interventional study of adult patients prescribed topical treatment with ingenol mebutate gel (Picato®) as part of provision of care for the treatment of Non-hyperkeratotic, non-hypertrophic Actinic Keratosis (AK). Patients with complete clearance at 8 weeks will be followed for one year or until retreatment of AK in the area initially treated, whatever comes first. For patients with incomplete clearance in the treated area at 8 weeks the treatment strategy for this area will be recorded but no further follow-up will take place. The effectiveness, tolerability, adherence, patient satisfaction and health-related quality of life (HRQoL) associated with Picato® treatment will be evaluated.

NCT ID: NCT02559934 Completed - Actinic Keratosis Clinical Trials

Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis

Start date: November 2015
Phase: Phase 1
Study type: Interventional

The aim of this study is to assess the delivery of SR-T100 from the topical gel (containing 2.3% solamargine in Solanum undatum plant extract) by determining the plasma levels of solamargine in subjects with AK while administration of a 25 cm2 contiguous or non-contiguous dermal treatment area.

NCT ID: NCT02549352 Completed - Actinic Keratosis Clinical Trials

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up

Start date: November 2015
Phase: Phase 3
Study type: Interventional

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment

NCT ID: NCT02549339 Completed - Actinic Keratosis Clinical Trials

Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up

Start date: November 13, 2015
Phase: Phase 3
Study type: Interventional

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment

NCT ID: NCT02547363 Completed - Actinic Keratosis Clinical Trials

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up

Start date: November 2015
Phase: Phase 3
Study type: Interventional

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment.

NCT ID: NCT02547233 Completed - Actinic Keratosis Clinical Trials

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up

Start date: November 2015
Phase: Phase 3
Study type: Interventional

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment.

NCT ID: NCT02520700 Completed - Actinic Keratoses Clinical Trials

A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses

Start date: September 2013
Phase: N/A
Study type: Interventional

Photodynamic therapy (PDT) uses visible light to treat a premalignant condition, called actinic keratosis, which results on chronically sun exposed skin such as on a balding scalp. A cream is applied containing aminolaevulinic acid or methyl aminolaevulinate and this is converted in the cells to the photodegradable product protoporphyrin IX (PpIX). Visible light causes the degradation of PpIX resulting in the production of reactive oxygen species and then cell death in the actinic keratosis. In conventional PDT a lamp is used to supply the visible light. The main draw back to treatment is pain. Recent studies have shown that daylight can be used as the source of visible light and is as effective as conventional PDT. Patients find this form of treatment less painful and therefore preferable. The reduction in pain seen in daylight PDT appears to be related to the fact that no significant quantity of PpIX accumulates prior to exposure to the light source and small quantities of PpIX are activated continuously during daylight exposure. The drawback of performing daylight PDT in Ireland is the climate, both in terms of cloud cover and temperature. The typical daylight treatment times is 2 hours and it would be difficult for patients to stay outside in winter, spring and autumn. This study investigates the use of an artificial white light source, a Maquet PWD 50SF theatre-light, as an alternative.

NCT ID: NCT02464709 Completed - Actinic Keratosis Clinical Trials

Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)

Start date: June 2015
Phase: Phase 4
Study type: Interventional

This study compares two photosensitizing creams' BF-200 ALA's (aminolevulinic acid, Ameluz®) and MAL's (methyl 5-aminolevulinate, Metvix®) efficacy on actinic keratoses in natural daylight photodynamic therapy (NDL-PDT). The participants' facial skin or scalp will be randomized in two sides and one side is treated with BF-200 ALA and the other side with MAL. Result of the treatment is assessed with clinical examination 12 months after treatment. The investigators will also compare delayed skin reactions after treatment and cost-effectiveness of both photosensitizer creams.