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NCT07286318
A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Organ Transplant Recipients This study is designed to evaluate whether a topical 5% niacinamide cream can help prevent skin cancer in organ transplant recipients. Individuals who have received an organ transplant have a much higher risk of developing precancerous skin growths and skin cancers because of long-term immune-suppressing medications. Although sunscreen is an important part of sun protection, additional preventive approaches are needed. Early research suggests that niacinamide may help protect the skin, and this trial will examine whether a topical formulation provides benefit in this high-risk group. The study will test whether daily use of topical 5% niacinamide reduces the number of actinic keratoses over 6 and 12 months and whether it decreases the development of new keratinocyte cancers when compared with sunscreen alone. The study will also evaluate how well the topical product is tolerated and whether it can be used consistently as part of a daily skin-care routine. A total of 20 adult organ transplant recipients with a history of multiple actinic keratoses and at least one prior non-melanoma skin cancer will enroll in this 12-month, randomized, controlled trial. Participants will be assigned to receive either daily topical 5% niacinamide plus sunscreen or sunscreen alone. Skin examinations will be performed at 6 and 12 months using standardized mapping methods. Information on treatment tolerability, adherence, and any side effects will be collected through structured surveys, and any lesions suspicious for cancer will be evaluated by a board-certified pathologist.
NCT07340697
This clinical trial will assess the safety and tolerability of topical application of RLS-1496 cream to lesions and adjacent skin on the left forearm of adults with actinic keratoses (AK) on the arms. The right forearm will remain untreated as a control. The therapeutic objective of topical treatment with RLS-1496 cream is to clear or decrease the number of AK in the treated area, per lesion counts performed by the Investigator. The main questions it aims to answer are: * Is it safe to apply topical RLS-1496 cream to treat AK once daily for 28 days? * Does topical RLS-1496 lower the number of AKs or eliminate AKs in a treated area when applied once daily for 28 days? Researchers will compare results on the left (treated with RLS-1496) and right (no treatment) forearm. Participants will apply RLS-1496 to an identified area on the left forearm once each day for 28 days and have intermittent clinic visits to examine the arms and have the AK lesions counted until 28 days after the last application of RLS-1496. Participants will also have small skin biopsies on the arms.
NCT07290959
Several treatments are available for actinic keratosis (AK), many of which are hampered by local inflammation, pain, long duration, and slow healing. Indoor daylight photodynamic therapy (idl-PDT) is an effective, well-tolerated, first-line treatment for both AK and field cancerization, but the feasibility of this treatment is limited by the long time required for the illumination (2 hours). Objective of this study was to evaluate the efficacy of idl-PDT with an illumination time of 1 hour versus 2 hours in the treatment of scalp AK. Adult patients (age \>50 years) with multiple AK located on the scalp (at least 5 Olsen grade I or II AK in two symmetrical areas) and diagnosed according to the typical clinical appearance were enrolled at two Dermatology Units in Italy. Exclusion criteria were the followings: previous treatment for AK within 6 months; status of congenital, infectious, or iatrogenic immunodepression; known cutaneous photosensitivity; known hypersensitivity to any ingredient of Metvix® 135 mg/g cream (Galderma SA, Lausanne, Switzerland). AK lesions on the scalp were mapped photographically with the support of a transparent sheet and graded according to Olsen grading scale. Two contralateral and symmetric areas of the scalp containing at least 5 AK were identified. Randomization of the two target areas for the two illumination durations (1 hour vs 2 hours) was performed with a 1:1 allocation ratio with a computer-generated list using permuted random blocks of six to ensure allocation concealment. At baseline, the following data were recorded: age, sex, phototype, Olsen grade and number of AK per side, any previous therapies on the treated area, any previous surgical excision of malignant skin neoplasms on the treated area, and comorbidities. The skin area to be treated was prepared with a sterile gauze pad soaked in saline solution to remove scales and crusts and then a 1 mm thick layer of cream containing 160mg/g of MAL (Metvix®) was applied. After 30 minutes of application, according to clinical practice and approved protocol, exposure to the white polychromatic LED lamp (Dermaris®, Surgiris, Croix, France, 400-700nm, fixed distance 30 cm, irradiance 72.6 W/m2 156 ) was performed, for a duration of 1 hour on one half and 2 hours on the other half, according to randomization. The emission spectrum of the light source was measured with a SR 9910 spectroradiometer (Macam Photometrics Ltd, Livingston, UK). The light doses were 26.1 J/cm2 for 1 hour illumination and 52.3 J/cm2 for 2 hours illumination, and the effective light doses for PpIX photoactivation were 0.69 Jeff/cm2 160 for 1 hour illumination and 1.39 Jeff/cm2 for 2 hours illumination. The effective light dose was calculated with the normalized PpIX absorption spectrum, the spectral irradiance of the lamps and treatment duration. Patients were evaluated 3 months and 6 months after the idl-PDT session to assess the efficacy of the two illumination times. A clinical photograph of the treated area was taken after 1 hour, 24 hours, and at each of the two follow-up visits. The primary endpoint of the study was the lesion response rate at 3 months. The analysis was performed on the total number of AK and after categorization of AK according to Olsen clinical grade. The secondary endpoints were lesion response rate at 6 months, tolerability and physicians' and patients' satisfaction. Tolerability was assessed as follows: subject's assessment of maximal pain perceived according to treated side immediately after the end of the treatment on a 0-10 numeric rating scale (NRS), from 0 (no pain) to 10 (extreme pain); local skin reactions (LSRs) assessed 1 hour and 24 hours after the treatment, including erythema, scaling, crusting, edema, blistering/pustulation and erosion/ulceration, each classified according to a 0-4 scale of severity (total LSR score range: 0-24). At the 3-months follow up visit, physicians rated their level of satisfaction on a 4-point scale with respect to treatment efficacy (very effective, effective, poorly effective, ineffective) and cosmetic outcome (excellent, good, poor or worse) for each treated area. In addition, patients were administered a questionnaire to globally assess convenience of the treatment (very convenient, convenient, poorly convenient, inconvenient) and overall level of satisfaction (very satisfied, satisfied, poorly satisfied, not satisfied at all) on a 4-point scale. The patient's willingness to undergo any further treatment with idl-PDT was recorded.
NCT06648447
The aim of this study is to observe the influence of tirbanibulin on proliferation patterns of actinic keratoses (efficacy on proliferation score according to Schmitz et al.). For this purpose, tirbanibulin is applied in-label, proliferation is measured by LC-OCT at different time points and dermatohistopathology is performed (optionally) at the end. Local skin reactions to the product will also be recorded (tolerability).