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Keratosis, Actinic clinical trials

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NCT ID: NCT01413763 Active, not recruiting - Actinic Keratosis Clinical Trials

Potential Effect of Topical Imiquimod on Atrial Ectopy in Patients With Actinic Keratosis

Start date: July 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the potential effect of topically applied 3.75% imiquimod cream on atrial ectopy in actinic keratosis (AK) patients. The primary endpoint is the change in the 24-hour supraventricular premature beat count. The secondary endpoint is the change in 24-hour supraventricular premature couplet and run counts and atrial fibrillation (% time); change in 24-hour mean heart rate; change in 24-hour ventricular premature beat count, ventricular premature couplet and run counts.

NCT ID: NCT01405144 Unknown status - Actinic Keratosis Clinical Trials

5fluorouracil for Advanced Photoaging

Start date: August 2010
Phase: Phase 3
Study type: Interventional

It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging while treating Aks was reported. The aim of this study is to compare the efficacy and safety of the two modalities of 5% 5-FU use for forearms photoaging.

NCT ID: NCT01387711 Completed - Actinic Keratosis Clinical Trials

PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology

Start date: August 2011
Phase: Phase 1
Study type: Interventional

This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by histology.

NCT ID: NCT01358851 Completed - Actinic Keratosis Clinical Trials

LAS41005 in Hyperkeratotic Actinic Keratosis

Start date: April 2011
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies).

NCT ID: NCT01354717 Completed - Actinic Keratoses Clinical Trials

Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo

Start date: September 2010
Phase: Phase 3
Study type: Interventional

This is a double-blind, randomized, placebo-controlled, three treatment parallel study in which normal, healthy men and women (age 45-85) with actinic keratosis will be treated on the face once daily for two weeks with 5-Fluorouracil Cream 0.5%, Spear Pharmaceuticals (Generic), Carac® Cream 0.5% (Brand), or Cream Vehicle (Placebo). Actinic keratoses will be counted at the baseline visit and at the visit four weeks following cessation of treatment.

NCT ID: NCT01302925 Completed - Healthy Clinical Trials

PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects

Start date: February 2011
Phase: Phase 1
Study type: Interventional

The purpose of this phase 1 trial is to investigate the local tolerability on the finger following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3 consecutive days.

NCT ID: NCT01281644 Completed - Clinical trials for Keratosis Pilaris (KP)

Treatment of Keratosis Pilaris With 810 nm Diode Laser

KP
Start date: March 2011
Phase: N/A
Study type: Interventional

The investigators hope to establish whether or not the diode laser, a longer-wavelength laser, is effective in treating keratosis pilaris, and hopefully opening a door into the discussion and management of this skin condition. The primary outcome of interest is the difference in the overall blind rater severity scores of the treated versus the untreated sites. The secondary outcome of interest is the change in the patient's self-rated severity score of the treated site. To account for potential natural disease progression or regression, the investigators will also compare patient mean changes to the mean changes in severity scores of the untreated site.

NCT ID: NCT01265602 Completed - Actinic Keratosis Clinical Trials

Double-blind, Randomized, Vehicle- and Comparator-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of LAS41007 in the Treatment of Actinic Keratosis

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine the efficacy, safety and tolerability of LAS41007 compared to a marketed reference product as well as to vehicle (topical application, twice daily, indication mild to moderate AK).

NCT ID: NCT01260987 Completed - Clinical trials for Basal Cell Carcinoma

Fractional CO2 Laser Assisted Photodynamic Therapy

Start date: October 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Nodular Basal Cell Carcinomas: Compare the efficacy and safety of conventional versus fractional laser assisted PDT for difficult to treat nodular cell carcinomas in the face. Actinic keratosis: Compare the efficacy and safety of conventional versus fractional laser assisted PDT for moderate to severe actinic keratoses located in the face and on the hands.

NCT ID: NCT01229319 Recruiting - Actinic Keratosis Clinical Trials

Imiquimod 3.75% Cream in Combination With Cryotherapy in the Treatment of Hypertrophic Actinic Keratoses

Start date: October 2010
Phase: Phase 4
Study type: Interventional

Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). In addition, the skin around clinically obvious AK lesions has been subject to the same chronic ultraviolet exposure, resulting in genetic damage and mutations, resulting in "field cancerization." Subclinical AKs may progress to clinical AKs, or even de novo invasive SCCs. Among the current therapies for the treatment of AK are excisional surgery, cryosurgery, electrodessication and curettage, topical chemotherapy and light therapies. With cryotherapy, treated lesion clearance rates at 3 months post-treatment after double-freeze thaw cryotherapy has been reported to be around 76-88%; Overall lesion clearance rate at approximately 5 months post-cryosurgery has been reported to be 35-51%. Imiquimod is a topical immune response modifier and a 5% formulation has been approved for the treatment of AKs in the US as a 2x/week for 16 week regimen and in Europe as a 3x/week for 4 week regimen for 1 or 2 courses of therapy. Topical imiquimod treatment may also reduce subclinical lesions in the treatment area, resulting in fewer "new" AK lesions developing over the same period of time when compared to focal treatment. In a comparison of cryosurgery versus imiquimod for the treatment of AKs, Krawtchenko et al reported initial complete clearance rates of 68 and 85% by clinical assessment, respectively. However, the treatment field sustained clearance rate was 4% versus 73%, respectively. Tan et al reported that while application of imiquimod or vehicle following cryosurgery resulted in comparable target AK clearance rates at 12 weeks of 79% versus 76%, respectively, the imiquimod group had fewer total AKs and fewer subclinical AKs. Imiquimod cream at a concentration of 3.75% has been found in Phase 3 studies to be superior to placebo cream with respect to clearance of AKs using a regimen of up to 2 packets (250 mg of cream per packet, 500 mg total) applied daily to the entire face (approximately 200 cm2) for two 2-week treatment cycles separated by a 2-week no-treatment period. This study aims to examine the benefit of cryotherapy in combination with imiquimod 3.75% compared to cryotherapy alone.