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Actinic Cheilitis clinical trials

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NCT ID: NCT04744103 Not yet recruiting - Actinic Cheilitis Clinical Trials

Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis

Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

Actinic cheilitis is a condition of the lower lip characterized by grayish-white areas of discoloration and blunting of the demarcation between the cutaneous lip and the mucosa. While many studies have compared treatment options for actinic cheilitis, there is still significant debate over how to best manage this condition. The chosen treatment regimen must result in complete remission while also preventing recurrence and malignant transformation. Current treatment options are vast, including both non-surgical and surgical options. Common topical therapies include 5-fluorouracil, imiquimod, ingenol mebutate and diclofenac. More recently, photodynamic therapy has been brought forward as a potential treatment modality. From a surgical perspective, a vermilionectomy is typically the procedure of choice. TCA is a popular topical treatment for treat fine rhytides, hyperpigmentation, photodamage, and premalignant changes, such as actinic keratoses. Despite this, TCA is not commonly used for actinic changes on the lips. Here, the investigators propose an expansion of the application of TCA to be used in the treatment of actinic cheilitis.

NCT ID: NCT04219358 Recruiting - Actinic Cheilitis Clinical Trials

Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis

Start date: March 23, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Actinic cheilitis is a potentially malignant lesion on the lower lip, which can progress to more serious illnesses such as cancer if not treated. Usually treatment of this condition is only based on clinical appearance, but there is no established cure treatment. Topical imiquimod is a medicine indicated for the treatment of skin diseases, but it has not yet been proven to treat actinic cheilitis. In this research, the investigator's aim is to evaluate the response to actinic cheilitis treatment with the current standard treatment compared to high and low concentration imiquimod topical formulations.

NCT ID: NCT03990636 Not yet recruiting - Actinic Cheilitis Clinical Trials

Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial

Start date: October 17, 2019
Phase: Phase 2
Study type: Interventional

Brazil is a tropical country, with high incidence of ultraviolet radiation throughout the year. Many Europeans migrated to Brazil escaping either war or economic crisis to live in the country searching for opportunities. Low phototype combined with high incidence of UV light is a combination that not only affect the skin but also the lips. The current study was designed to use photodynamic therapy with metil 5-aminolevulinate for actinic cheilitis in a phase 2 clinical trial.

NCT ID: NCT03452566 Withdrawn - Actinic Cheilitis Clinical Trials

Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment

Start date: February 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Actinic cheilitis is a major potentially carcinogenic disorder of the lower lip and several reports of clinical cases with excellent results for the treatment of this lesion that can differentiate to squamous cell carcinoma of the lip. However, clinical trials are lacking to define the optimal dosage of the drug for a therapeutic modality and to define its true efficacy in controlled studies of this pre-malignant labial lesion.

NCT ID: NCT03224715 Withdrawn - Actinic Cheilitis Clinical Trials

Actinic Cheilitis Pre-Treated With DNA Repair Enzyme Cream

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

It is well known that ultraviolet (UV) light causes sunburn and DNA damage that can lead to skin cancer. Despite preventative measures of sunscreens and other topicals the incidence of skin cancers continues to increase every year. Chronic exposure can lead to development of both basal and squamous cell carcinoma that also is correlated to the risk of melanoma. When epidermal keratinocytes are exposed to UV radiation, they form cyclobutane pyrimidine dimmers (CPDs), 6-pyrimidine-4-pyrimidones (6-4-PPs), and oxygen radicals that alter the structure of nucleotides. When these lesions are not repaired, DNA replication is altered that leads to mutations in p53 and PTCH tumor suppressor gene and ultimately tumor development. It has been discovered that intracellular delivery of bacterial DNA incision repair enzyme T4 endonuclease V DNA repair enzymes can repair sun induced damaged DNA in patients with xeroderma pigmentosum4,. Yarosh et al also showed that T4 endonuclease V DNA repair enzymes are specific to reducing the amount of cyclobutane pyrimidine dimers and were found to lower the rate of new actinic keratoses compared to placebo lotion by 68% with no adverse effects observed. Additionally Yarosh et al also showed that T4N5 liposomes can repair keratinocyte DNA in skin cancer patients. This study will examine if pretreating actinic cheilitis with DNA repair enzyme cream before standard treatments can decrease the need for additional and possibly more aggressive therapies, decrease the surface area of affected areas, and possibly improve skin thickening and texture.

NCT ID: NCT02409732 Completed - Actinic Cheilitis Clinical Trials

Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis

Start date: April 2015
Phase: Phase 4
Study type: Interventional

To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the treatment of actinic cheilitis.

NCT ID: NCT02198469 Completed - Actinic Cheilitis Clinical Trials

Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Actinic Cheilitis

Start date: January 2012
Phase: Phase 1
Study type: Interventional

Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few cosmetic side effects and minimises patient discomfort. However, its relatively low efficacy prevents its application to the treatment of actinic cheilitis(AC). Er:YAG ablative fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no studies have directly compared the efficacy of MAL-PDT with and without Er:YAG AFL in treating AC

NCT ID: NCT00868088 Completed - Actinic Cheilitis Clinical Trials

Photodynamic Therapy to Treat Actinic Damage in Patients With Squamous Cell Carcinoma (SCC) of the Lip

Start date: July 2009
Phase: Phase 4
Study type: Interventional

Our study is designed to evaluate the efficacy of photodynamic therapy (PDT) for treatment of actinic cheilitis (AC) and as an adjunct to Mohs surgery for squamous cell carcinoma (SCC) on the lips. This study will utilize an FDA approved PDT modality (DUSA, Inc., Wilmington, MA 01887) using topical 5-amino-levulinic acid (ALA) for photosensitization followed by exposure to a Blu-U light source emitting 405-420nm wavelength light.

NCT ID: NCT00849992 Completed - Actinic Cheilitis Clinical Trials

Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy

Start date: March 2009
Phase: Phase 4
Study type: Interventional

Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin analysis), epidemiological data and follow-up data.