View clinical trials related to Actinic Keratosis.
Filter by: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.
Photodynamic therapy is an effective treatment for actinic keratoses. In the United States topical aminolevulinic acid (ALA) is approved as a photosensitizing agent for this treatment, and it has traditionally been activated with the use of an in-office artificial light source. This clinical trial seeks to measure the safety and efficacy of using natural sunlight to activate the ALA.
The purpose of this research is to obtain a blood sample from patients with actinic keratoses undergoing routine Photodynamic Therapy, in order to measure biomarkers that are relevant to VitD and 5FU metabolism and might be predictive of PDT outcome. The biomarkers to be examined include serum VitD levels at the time of PDT, and the presence/absence of gene alleles that correlate with expression of several proteins involved in VitD and 5FU metabolism. The presence of these biomarkers will be correlated to the improvement in AK lesion counts at the patient's routine follow-up visit 3 months after PDT treatment.
This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% in adult participants when applied to an area of skin containing 4-8 stable, clinically typical actinic keratosis (AK) lesions on the face or scalp.
To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of Actinic Keratosis (AK) Lesions
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatment of AK on the face and scalp.
The study team plans to enroll a total of 40 subjects with self-reported perimenstrual acne. Eligible women will be over the age of 18 and not on any current therapy. The patients will first arrive for a screening visit, where they will be given questionnaires on acne quality of life (acne QOL) and subjective assessments as well as flare ups (as used in the study by Geller et al). The patients' skin will be assessed for inflammatory and non-inflammatory acne vulgaris. The baseline visit (day 1) will be scheduled for one week prior to the first day of menses (as studies indicate that most women have their acne flare during this time). The study team will perform a zit count (counting papules, pustules, and comedones) and global assessment, and the patient will be instructed to record their menses (which they will do for the duration of the study). The patients will then return in 2 weeks, at day 15, and they will be re-assessed. The patients will be dispensed the investigational product and instructed on its daily use. The patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study). The duration of the study per patient is approximately 4 months, and the study team anticipates an enrollment period of 12 months.
One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial. In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.
This is a pilot, phase 2, prospective, comparative study to evaluate the safety and efficacy of the combination of Levulan® Kerastick® for Topical Solution and blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator (LevulanPDT). The study hypothesis is that post solid organ transplantation patients, highly susceptible to non-melanoma skin cancer, can be treated safely and effectively through clinical cyclic application of PDT, lessening morbidity and possible mortality for this immunosuppressed patient population.
A Phase 2, randomized, double-blind, dose rising study to determine the safety, tolerability, and preliminary efficacy of four concentrations of SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment (SOR007) compared to SOR007 ointment vehicle applied to actinic keratosis (AK) lesions on the face twice daily for up to 28 days.