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Keratosis, Actinic clinical trials

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NCT ID: NCT05164393 Active, not recruiting - Actinic Keratoses Clinical Trials

Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK

COAKS
Start date: November 2, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Actinic keratosis (AK), also known as solar keratosis, is a common skin condition characterised by abnormal growth of skin cells caused by long-term sun exposure. AK is considered to be a precancerous lesion, and is therefore commonly treated to reduce the risk of malignant transformation into skin cancer. The trial is a randomised, double-blind, vehicle-controlled, dose-comparison trial in which adult subjects with AK grade 1 or 2 will be treated with AVX001 silicone-based gel in doses of 1% or 3% or with a gel vehicle for a 4-week field-directed treatment period. Subjects will be followed up for 8 weeks after the treatment period. The primary objective is to evaluate the local tolerability of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle.

NCT ID: NCT05152407 Not yet recruiting - Actinic Keratosis Clinical Trials

MRB 0.3% Serum Effectiveness on 2 Early Clinical Markers of Photoinduced Cutaneous Aging: Actinic Lentigo and Actinic Keratosis

Start date: January 2022
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate effectiveness of a serum containing 0.3% of MRB, a cosmetic active ingredient, against actinic lentigo and actinic keratosis.

NCT ID: NCT05136144 Active, not recruiting - Clinical trials for Seborrheic Keratosis

Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis

Start date: October 19, 2021
Phase: Phase 2
Study type: Interventional

This is a first-in-humans adaptive design open label trial to explore the safety and efficacy of SM-020. Multiple dosing cohorts will be enrolled. The first cohort will have a two-week treatment period of twice daily applications followed by a four-week follow-up period. Based on the results at any time from the first and subsequent cohorts, additional cohorts will explore different dosing regimens.

NCT ID: NCT05078827 Completed - Actinic Keratoses Clinical Trials

Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of MylanPharmaceuticals Inc., U.S.A in the Treatment of Actinic Keratosis

Start date: March 1, 2022
Phase: Phase 3
Study type: Interventional

Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites.

NCT ID: NCT05060237 Completed - Actinic Keratosis Clinical Trials

Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp

Start date: December 1, 2021
Phase: Phase 1
Study type: Interventional

The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp.

NCT ID: NCT04969419 Completed - Melanoma (Skin) Clinical Trials

Incidence of Melanoma and Non-melanoma Skin Cancer in People With Vitiligo

Start date: June 18, 2021
Phase:
Study type: Observational

This study examines melanoma and nonmelanoma skin cancer in people diagnosed with vitiligo compared to matched controls.

NCT ID: NCT04875026 Completed - Actinic Keratoses Clinical Trials

Frequency and Intensity of Local Reactions in Patients Treated With 4% 5-FU vs 4% 5-FU Associated With an Emollient Cream: a Randomised, Controlled Clinical Trial

Start date: February 16, 2021
Phase: Phase 4
Study type: Interventional

Transient local skin reactions with topical Actinic Keratosis treatments such as 5-FluoroUracil (5-FU) often lead to non-adhesion from patients and thus to treatment failure. In regards to 5-FU treatment, these local reactions are related to the pharmacological action of the molecule. The current therapeutic challenge is to reduce the local reactions induced by 5-FU without interfering with its efficacy, in particular by the use of an emollient cream. The aim of the present study is to investigate how the use of an emollient, namely Dexeryl, could improve the local skin reactions occurring during 4 weeks of a 4% 5-FU treatment.

NCT ID: NCT04843553 Completed - Actinic Keratoses Clinical Trials

Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients

NICE
Start date: October 14, 2016
Phase: Early Phase 1
Study type: Interventional

Skin cancers and pre-cancerous growths (called actinic keratoses, "AKs"), that aren't melanomas, develop in patients with a kidney transplant at excessive rates. When these pre-cancerous AKs, and "non-melanoma" skin cancers occur in kidney transplant patients, they tend to be aggressive, and require frequent medical procedures, often surgery, for the removal of the skin cancers. If not removed adequately the pre-cancers can develop into skin cancers, and the skin cancers, if not removed, may spread, and even cause death. Reducing the occurrence and complications of these skin cancers and pre-cancers in kidney transplant patients with a safe, effective, well-tolerated treatment taken by mouth would be an important medical advance. We are testing oral nicotinamide (NAM)-a B-vitamin compound-for that purpose. Approximately fifty kidney transplant patients who have had at least one non-melanoma skin cancer in the past, will be given randomized to receive NAM, 1 gram twice daily by mouth, or identical pills without NAM, and followed for 1 year to see if NAM treatment reduces the numbers of pre-cancerous AKs, and non-melanoma skin cancers they develop. Patients will be asked to come to the clinic for 3 follow up visits (every 4 months for up to 12 months). They will receive a full body skin exam by a dermatologist, have detailed counting of AKs and biopsies for any suspicious lesions as standard of care. Blood will also be drawn as well as a urine sample obtained at each visit for safety assessment and storage. We will also ask them to answer a series of questions about dietary patterns and intake of whole foods and supplements.

NCT ID: NCT04842422 Completed - Actinic Keratoses Clinical Trials

Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream

Start date: April 16, 2021
Phase: Phase 4
Study type: Interventional

Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream: The study is to demonstrate that Aktinic Keratosis are present before they are clinically visible, i.e. in a subclinical stage. Since on the basis of the research situation, also subclinical AK can proliferate into the dermis, it is possible that with the application of Imiquimod on chronically light-exposed skin, undetected squamous cell carcinoma can be recognized and treated at the same time.

NCT ID: NCT04814953 Enrolling by invitation - Clinical trials for Squamous Cell Carcinoma

HRQoL Keratinocyte Carcinomas

Start date: July 1, 2020
Phase:
Study type: Observational

Rationale: Keratinocyte skin cancer is known to influence the HRQoL in a specific way. Derived utility values are required for cost-effectiveness analyses of new interventions. However there is no sensitive tool to capture HRQoL that translates into utilities available. Objective: To document the exact HRQoL in patients with in KC using the generic EQ-5D-5L questionnaire, as well as the TTO, 15D and the BaSQoL questionnaire, and to develop health utilities based on these tools. Study design: Longitudinal observational study (at time 0 and time 0 +12 months). Study population: Patients aged ≥18 years consulting a dermatologist or their GP for diagnosis, treatment or follow-up of a (pre)malignant skin lesion(s).