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Actinic Keratosis clinical trials

View clinical trials related to Actinic Keratosis.

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NCT ID: NCT03037541 Completed - Actinic Keratosis Clinical Trials

Cryosurgery and Cream Combination for Actinic Keratosis

Start date: January 5, 2011
Phase: Phase 3
Study type: Interventional

Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as tolerated, though local irritation often occurs within the first week of treatment and increases in a dose-dependent manner. In this study, the investigators will examine the combination of standard cryosurgery treatment followed by a shortened course of topical fluorouracil cram. The investigators anticipate that a one week treatment course will maintain overall effectiveness when combined with previous cryosurgery, but will reduce the overall adverse effects of topical therapy due to the reduced treatment time and the presence of fewer baseline lesions to treat. This treatment approach may provide a more acceptable risk/benefit ratio option for patients with more extensive disease and simplify standard combination treatment options. The primary objective is to evaluate the efficacy of combination cryosurgery and 5-fluorouracil0.5% cream, compared to combination cryosurgery and placebo in the treatment of actinic keratosis lesions. The efficacy of this combination therapy will be evaluated by assessing AK lesion clearance. The primary efficacy parameter will be 10% clearance of all AK lesions from treatment initiation to end-of-treatment.

NCT ID: NCT03024060 Withdrawn - Actinic Keratosis Clinical Trials

Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp

Start date: March 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.

NCT ID: NCT03013647 Recruiting - Actinic Keratosis Clinical Trials

Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization

Start date: September 2016
Phase: N/A
Study type: Interventional

Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and will be treated with Daylight Photodynamic therapy. Before and after skin biopsies will be performed, for histological and immunohistochemical analysis.

NCT ID: NCT03006185 Completed - Actinic Keratosis Clinical Trials

Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin

Start date: August 2016
Phase: Phase 2
Study type: Interventional

Comparison of treatment efficacy and safety of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic therapy with methyl aminolevulinate for actinic keratoses

NCT ID: NCT02990221 Completed - Actinic Keratosis Clinical Trials

Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization vs Cryotherapy

Start date: April 12, 2017
Phase: Phase 4
Study type: Interventional

The main objective of this study is to compare the effectiveness of ingenol mebutate gel (150 mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or scalp, for 3 days consecutive) cryotherapy (application with 5 seconds of freezing time of each lesion located in a predetermined skin area of 25 cm2 of the face or scalp) in the treatment of actinic keratosis and their field cancerization. Study details: This study is randomized. 50 subjects with at least two actinic keratoses of grade I and II, located in two different districts of 25 cm2 skin of the face or scalp, and who meet all the inclusion criteria will be enrolled in the study by the investigators in the three different centers mentioned above. The investigators will assess the effect of treatment by confocal microscopy and digital dermoscopy. The investigator will acquire images of selected areas of the face and scalp before and after treatment. Data will be collected and analyzed by the coordinating centre. Procedure for the study: Recruitment of subjects; random assignment of treatment (ingenol mebutate gel 150 micrograms/g and cryotherapy) to the two skin areas of 25 cm2 of the subject recruited; evaluation of the two areas with reflectance confocal microscopy and digital dermoscope. The measurements will be carried out at time 0, after 1 month and 6 months. The investigator must fill out a form for each subject at the beginning (day 0), after 1 month and at the end of the study (after 6 months). The subject must complete a questionnaire at the beginning (day 0), after 1 month and at the last follow-up visit (after 6 months). Measurement parameters: Dermoscopy and confocal microscopy will be used to assess the percentage reduction in actinic keratoses and the damage of the cancerous area in the two selected areas treated with ingenol mebutate gel or cryotherapy, respectively. Adverse / side events will be collected at each visit by the investigator and will be contained in another form.

NCT ID: NCT02984072 Completed - Actinic Keratosis Clinical Trials

Menthol for PDT Pain Relief

MentholPDT
Start date: October 23, 2018
Phase: Phase 4
Study type: Interventional

Topical photodynamic therapy (PDT) is widely used to treat superficial non-melanoma skin cancer (NMSC) and dysplasia, notably actinic keratosis and may also be effective in a range of other dermatological conditions. A major limitation of PDT is pain during irradiation. A lack of knowledge of the mechanism of PDT-induced pain has limited the development of effective approaches for prevention or relief of this adverse effect. The investigators have investigated the possible efficacy of menthol for PDT pain ex vivo and will now study this in a clinical trial. This proposal describes the prospective randomised double blind, placebo controlled clinical trial that will be undertaken to investigate the use of topical menthol for PDT-induced pain relief in patients with actinic keratosis of the face and scalp who will be attending general dermatology and PDT outpatient clinics at Ninewells Hospital, Dundee.

NCT ID: NCT02952898 Completed - Actinic Keratosis Clinical Trials

Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses

Start date: October 27, 2016
Phase: Phase 3
Study type: Interventional

This research study is being done to compare the safety and effectiveness of GDC 695 (test drug) against the currently marketed reference drug (diclofenac sodium gel, 3%) and to establish that these two drugs work better than placebo in the treatment of actinic keratosis.

NCT ID: NCT02938715 Completed - Actinic Keratosis Clinical Trials

Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil

Start date: October 2016
Phase: N/A
Study type: Interventional

In this study, subjects who are attending the dermatology clinic and who have already been prescribed topical 5-fluorouracial for the treatment of actinic keratoses as part of their standard of care will be recruited. The purpose of the study is to assess patient satisfaction when engaging in follow up treatment of actinic keratosis via the HIPAA-compliant teledermatology platform called Klara. Additionally, the goal is to assess the difference in total duration of treatment between treatment and control group. A total of 50 subjects will be enrolled and will be randomly assigned into the treatment group (teledermatology group; n=25) or control group (telephone only group; n=25).

NCT ID: NCT02902822 Completed - Melanoma Clinical Trials

Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo

Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the validity and utility of a tele-dermatology system in the midterm periodic screening of non-widespread skin lesions of recent onset or for which a specialized early classification is deemed to change the prognosis - including precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to control visits at fixed follow-up.

NCT ID: NCT02878382 Completed - Actinic Keratosis Clinical Trials

Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT

PDT
Start date: October 2016
Phase: N/A
Study type: Interventional

In topical photodynamic therapy (PDT) for non-melanoma skin cancers, a photosensitizing prodrug, 5-aminolaevulinic acid (ALA) or its methylated ester, methyl aminolevulinate (MAL), is converted to the endogenous photosensitizer protoporphyrinIX (PpIX). Reduced response rates are observed in thicker skin lesions, which may be due to insufficient PpIX accumulation within the target tissue. To enhance PpIX production,several physical and chemical pretreatments have been suggested. One of the chemical substances proposed to stimulate PpIX production is vitamin D because of its ability of being a keratinocyte pro-differentiating hormone. Based on in vitro and in animal model studies, we propose to study the potential impact of patient vitamin D pre-treatment in AK response to MAL-PDT.