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Keratosis, Actinic clinical trials

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NCT ID: NCT02278861 Completed - Actinic Keratosis Clinical Trials

Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis

ARISOAK
Start date: November 2011
Phase: Phase 2
Study type: Interventional

Actinic keratosis (AKs) are premalignant disorders that can evolve into skin cancer. To prevent their development, a study is being conducted with oral isotretinoin and topical tretinoin to verify what drug is the most effective and has the best security profile for these patients. Along with these treatments, cryotherapy with liquid nitrogen and sunscreens will be part of the treatment. The study will have the duration of 10 months. In the first four months, the AKs will be counted and treated with cryotherapy (face and arms) and sunscreens FPS 60 will be used. After it, the patients will return (the AKs will be counted), a new session of cryotherapy will be performed and they will be randomized into two groups: one group using oral isotretinoin 10mg/day ( ISO: 30 patients) and the other one using tretinoin 0,05% cream (AR: 30 patients) applied on face and arms. Skin biopsies will be done for all 60 patients at the beginning of the treatment with retinoids (isotretinoin and tretinoin). After six months of treatment with retinoids, the study will be stopped, AKs will be counted again and skin biopsies will be done. Patients in the group ISO (oral isotretinoin) also have to make blood tests at the beginning, two months and after six months of the treatment. Clinical (AK counting), histological (improvement of parts of the skin) and immunohistochemical parameters will be evaluated to see what drug is more effective for prevention of AKs.

NCT ID: NCT02260180 Completed - Clinical trials for Seborrheic Keratosis

Study of A-101 for the Treatment of Seborrheic Keratosis

Start date: October 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis.

NCT ID: NCT02251652 Active, not recruiting - Actinic Keratoses Clinical Trials

Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses

Start date: April 2013
Phase: Phase 4
Study type: Interventional

Sequential therapy with cryosurgery and ingenol mebutate may optimize the treatment of hypertrophic AKs and also treat non-hypertrophic AKs in this anatomic location. Furthermore, use of ingenol mebutate will also be evaluated for potential treatment of subclinical lesions.

NCT ID: NCT02248298 Completed - Actinic Keratosis Clinical Trials

Efficacy of AFL-assisted PDT With Short Incubation Time in Actinic Keratosis

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

Photodynamic therapy (PDT) using methyl aminolevulinate (MAL) is an effective first-line treatment for actinic keratosis (AK). Erbium: yttrium-aluminium-garnet (Er:YAG) ablative fractional laser-assisted MAL-PDT (AFL-PDT) has shown significant benefit for the treatment of AK. However, knowledge on the optimal photosensitizer incubation time for AFL-PDT is limited

NCT ID: NCT02242747 Completed - Actinic Keratosis Clinical Trials

Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis

Start date: May 2014
Phase: N/A
Study type: Interventional

Background: 5% 5-fluorouracil cream (5-FU) is a well-established treatment for actinic keratosis (AK) and ingenol mebutate gel (IMB) is a new topical field therapy. Objective: To compare tolerability and safety of IMB with 5-FU for the treatment of facial AKs. Methods: Open-label, prospective, randomized, controlled clinical trial with 100 patients with AKs within 25-cm2 contiguous field on the face. IMB was applied daily for three consecutive days. 5-FU was applied twice a day for four weeks. Treatment effect was evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering ITT populations.

NCT ID: NCT02239679 Completed - Actinic Keratosis Clinical Trials

Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

Start date: September 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and effective in the treatment of actinic keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy.

NCT ID: NCT02209012 Completed - Actinic Keratosis Clinical Trials

Twelve Month Follow-Up of CP0108

Start date: August 2014
Phase: Phase 3
Study type: Observational

The purpose of this study is to determine the long-term safety and efficacy of Levulan PDT in subjects with multiple actinic keratosis of the upper extremities who received treatment as part of the DUSA CP0108 study.

NCT ID: NCT02160626 Completed - Clinical trials for Seborrheic Keratosis

Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis

Start date: June 2014
Phase: Phase 2
Study type: Interventional

The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.

NCT ID: NCT02150863 Terminated - Actinic Keratosis Clinical Trials

Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study

Start date: August 2014
Phase: N/A
Study type: Interventional

This project aims to treat field cancerization ( pre-skin cancers) in a manner that will reduce the future pre-skin cancers and non-melanoma skin cancers in patients with significant photodamage. This is 3 year prospective, randomized, controlled comparison of a single treatment with carbon dioxide laser resurfacing vs. carbon dioxide resurfacing plus autologous epidermal skin graft from a non sun exposed site vs. control. Thirty subjects will receive treatment with each of the modalities. The primary measures of efficacy are (a) count of the number of actinic keratosis and non melanoma skin cancers, (b) blinded evaluation of severity from standard digital photographs taken before and after the treatments, and (c) change in histology before and after treatment. Safety measures include (a) pain, (b) scarring, (c) wound healing, (d) and infection

NCT ID: NCT02149342 Recruiting - Actinic Keratoses Clinical Trials

Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2% and 2%HAL With 16%MAL

Start date: May 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12 months. Pain during and after treatments and adverse reactions at one week are recorded.