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Keratosis, Actinic clinical trials

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NCT ID: NCT03642535 Recruiting - Actinic Keratoses Clinical Trials

Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and Prevention

Start date: August 30, 2018
Phase: Phase 4
Study type: Interventional

Background Actinic keratoses (AKs) are often treated separately, lesion by lesion. However, in the past years, AKs have been described as a field disease and not limited to single clinically apparent lesions. Treatment should therefore target an area of field change which may treat the subclinical AKs and reduce the risk of development of further AKs, second tumours, and local recurrence. Objectives The investigators sought to investigate whether field ALA-PDT of facial actinic keratosis would prevent new AKs, in comparison with a lesion area receiving the same ALA-PDT, in patients with clinical signs of field cancerization. Methods Eighty patients, previously diagnosed as having AKs of the face, were randomized distribution into two groups. 10% aminolaevulinic acid (ALA)-PDT for field treatment was on one group and for a lesion area (Vehicle control cream was applied to the non-lesion area) was on the other group. During the next 5-year period of follow up, patients were clinically evaluated for new AKs.

NCT ID: NCT03606122 Completed - Actinic Keratoses Clinical Trials

5-ALA Patch-PDT of Actinic Keratosis on the Upper Extremities

Start date: July 12, 2018
Phase: Phase 2
Study type: Interventional

This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in patients with actinic keratosis on the upper extremities for the first time.

NCT ID: NCT03596619 Recruiting - Actinic Keratoses Clinical Trials

The Study of Plum-blossom Needling Enhancing Efficacy of Aminolevulinic Acid-photodynamic Therapy for Actinic Keratosis

Start date: August 30, 2018
Phase: N/A
Study type: Interventional

Background Limited in the depth of absorption and penetration of photosensitizers, ALA-PDT treatment is not strong enough for thickening significantly AK lesions. Pre-study has proved that plum-blossom needling facilitates delivery of topical ALA into the dermis. It could help ALA to diffuse a little more broadly in superficial dermis and obtain similar clinical effect with a much lower cost. Objective We sought to investigate whether plum-blossom needling (PBN) would enhance the efficacy of ALA-PDT for AKs. Methods Two hundred and fifty patients, previously diagnosed as having AKs of the face and scalp, were randomized distribution into two groups. The PBN-ALA-PDT group underwent vertical skin tapping with PBN before applying 10% ALA cream and narrow-band light-emitting diode (LED) irradiation (mean 633 nm, with a standard deviation [SD] of 10 nm; 100-200 J/cm2). The ALA-PDT group received ALA cream and irradiation only. During the next 1 year period of follow up, patients were clinically evaluated for new AKs.

NCT ID: NCT03575780 Completed - Actinic Keratoses Clinical Trials

Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis

Start date: September 7, 2018
Phase: Phase 1
Study type: Interventional

This Phase I study is designed to evaluate the systemic exposure and safety of KX2-391 Ointment in adult subjects when applied to an area of skin containing at least 5 clinically typical, visible, and discrete Actinic Keratosis lesions on the face or balding scalp.

NCT ID: NCT03538951 Completed - Actinic Keratosis Clinical Trials

Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis

Phase2b
Start date: May 23, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2 clinical study in patients with actinic keratosis involving daily application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84 days). This study has no placebo and the subjects enrolled in the study will know exactly what they are receiving. The objectives of the study are to evaluate the safety and benefit of these two strengths.

NCT ID: NCT03511326 Completed - Actinic Keratoses Clinical Trials

PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK

SESAME 2
Start date: June 7, 2017
Phase: Phase 4
Study type: Interventional

Interventional open label prospective and multicentre study conducted in Germany in subjects with thin or non-hyperkeratotic and non-pigmented multiple AKs in one anatomical area on the face (e.g., forehead or cheek or chin), excluding nose eyelids, lips and mucosa or balding scalp, using Luxerm® DL-PDT treatment.

NCT ID: NCT03508856 Completed - Actinic Keratosis Clinical Trials

Clinical and Histologic Evaluation of Picato 0.15% Gel in the Cosmetic Improvement of Photoaged Skin

Start date: November 9, 2015
Phase: N/A
Study type: Interventional

Clinical Evaluation: Subjects having actinic keratoses and meeting Glogau Photoaging Class III or IV complete the FDA approved 3 day course of Picato® 0.015% gel as approved for the treatment of facial Actinic Keratosis. Each subject undergoes clinical multiple-angle standardized photographs on day 1, day 7, day 30, and day 60. Full face photography will be obtained with the medical research digital camera. Both subjects and investigators complete questionnaires at each visit with individual questions regarding improvement in actinic keratoses and overall skin appearance, wrinkling, dyschromia, erythema, and textural quality of skin. Each characteristic listed above will be graded on a 5 point scale ranging from 0 (lowest quality/worst appearance) to 5 (highest quality/best appearance). In addition, investigators will examine the subject's face and assign a numeric assessment on a 9 point scale ranging from 0 to 8 using previously published verified Griffiths' Photonumeric Photoaging scale. A second and third investigator will be presented at random blinded pretreatment (day 0) and posttreatment (day 60) photographs of each subject and be asked to assign a numerical value from Griffiths' Photonumeric Photoaging Scale. These blinded investgators will be given no information regarding which day each photograph represents. Comparison will be made of skin quality questionnaire scores from each visit and the pre and post treatment Griffiths' Photonumeric Grades. The investigator opted against a split-face study design given the difficulty of blinding with this type of study as well as difficulty recruiting subjects willing to treat for two separate courses. Histologic Evaluation: Standard 3mm dermatology punch biopsies from clinically sun damaged skin will be taken. Biopsy will be taken from either the cosmetically acceptable pre-or infra-auricular area. A digital photograph will be taken and used to identify the pre-treatment biopsy site. Biopsies will be taken of 5 subjects before treatment and at day 60. Day 60 biopsies will be taken immediately adjacent to previously photographed and identified pre-treatment biopsies. Biopsies will be stained with hematoxylin and eosin and histologic features of pre and post treatment skin will be evaluated. Measurement of actinic keratoses, solar elastosis and overall epidermal and dermal thickness pre and post treatment will be compared.

NCT ID: NCT03487588 Completed - Clinical trials for Seborrheic Keratosis

An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses

SK-FAN
Start date: March 21, 2018
Phase: Phase 4
Study type: Interventional

This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.

NCT ID: NCT03483935 Completed - Actinic Keratoses Clinical Trials

Microwave Therapy for Treatment of Precancerous Actinic Keratoses

MTAK
Start date: March 7, 2018
Phase: N/A
Study type: Interventional

This is a two-stage feasibility study to determine if focussed microwave energy is a suitable treatment for Actinic Keratoses (AK). The two study stages are as follows: Stage 1: To determine the electrical properties of permittivity in AK on the hand and bald scalp for subsequent optimisation of the SWIFT instrument to provide the correct dose of microwave energy to the AK. Stage 2: 1. Evaluate the efficacy of microwave energy as a treatment for AK 2. Evaluate the long-term resolution of AK following microwave treatment 3. Assess the feasibility and acceptability of using microwave energy as a treatment for AK 4. Identify the potential mode of action of microwave energy in the treatment of AK. The primary objective is to evaluate the efficacy of microwave therapy versus no treatment on the resolution of AK lesions using visual assessment. The primary outcome measure is full or partial resolution of the AK assessed by skin examination.

NCT ID: NCT03447925 Completed - Keratosis Plantaris Clinical Trials

Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients

Start date: June 1, 2017
Phase: Phase 2
Study type: Interventional

This study evaluates the addition of medicinal plant in the treatment of diabetic foot keratosis. Half of participants will receive medicinal plant and other half will receive a placebo.