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Safety and Efficacy of Imiquimod Applied in Dose-Cycle for Actinic Keratoses

2014-07-23 21:48:29 | BioPortfolio

Summary

It is believed that imiquimod 5% cream has the potential to be an effective treatment for actinic keratoses. The purpose of this study is to evaluate the duration of the effect of topical imiquimod 5% topical cream for the treatment of actinic keratoses.

Description

This study will assess the safety and efficacy of imiquimod 5% cream applied to actinic keratoses on the head to reduce the size of lesions. The objective is to analyze the effect of dose cycling with respect to the complete clearance rate when imiquimod 5% cream is applied 3 times per week for 4 weeks in 1 or 2 cycles. The complete clearance rate is defined as the proportion of subjects with no clinically visible AK lesions in the treatment area at the end of cycle 1 or the end of cycle 2.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Actinic Keratoses

Intervention

imiquimod

Location

Clinical Trials Unit, Skin Care Centre, UBC Dermatology
Vancouver
British Columbia
Canada
V5Z 4E8

Status

Completed

Source

University of British Columbia

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:48:29-0400

Clinical Trials [203 Associated Clinical Trials listed on BioPortfolio]

Imiquimod and Actinic Keratoses: an Observational Study

Objective: To show how dermatologists treat actinic keratoses with imiquimod 5% cream in their daily clinical routine. Design: Prospective, non-interventional, observational, multicenter ...

Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses

The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally us...

A Study to Follow up Recurrence Rates of Actinic Keratoses One Year After Completion of Study 1487-IMIQ

The purpose of the study is to obtain recurrence rates and long-term safety data for patients who had been treating actinic keratoses on the face and scalp with 5 % Imiquimod Cream in a p...

Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis

At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently mar...

A Study to Evaluate the Effectiveness and Safety of Multiple Applications of Imiquimod 5% Cream for the Treatment of Actinic Keratoses in Organ Transplant Recipients

The purpose of the study is to compare effectiveness and safety of multiple applications of imiquimod 5% cream and vehicle cream in graft recipients suffering from actinic keratosis.

PubMed Articles [106 Associated PubMed Articles listed on BioPortfolio]

PDT with PPIX absorption peaks adjusted wavelengths: Safety and efficacy of a new irradiation procedure for actinic keratoses on the head.

Daylight photodynamic therapy (dl-PDT) is an effective and almost painless treatment for patients with actinic keratoses (AKs) but carries important limitations due to seasonal conditions. PDT with Pr...

Actinic Keratosis Clinical Course Correlates with Underlying Molecular Mechanisms.

Actinic keratoses (AKs) are common premalignant skin lesions triggered by excessive UV exposure. The majority of AKs regress or persist, but some progress to squamous cell carcinomas. The biomarkers a...

CME Answers: Update Actinic Keratoses.

Peptidase inhibitor 3 and chemokine ligand 27 may serve as biomarkers for actinic keratoses in organ transplant recipients.

Molecular profiling of tissue samples in organ transplant recipients (OTRs) may allow early and minimally invasive identification of actinic keratosis (AK). The aim of this study was to compare mRNA e...

Treatment of actinic keratoses and cancerization field of the face and scalp with 0.015% ingenol mebutate gel in Brazilian individuals: safety, tolerability and patients' perspectives.

Actinic keratosis (AK) represents a risk of progression to squamous cell carcinoma. Ingenol mebutate gel is a novel therapeutic option for field-directed treatment.

Medical and Biotech [MESH] Definitions

A pattern recognition receptor that binds several forms of imidazo-quinoline including the antiviral compound Imiquimod.

A compound produced from succinyl-CoA and GLYCINE as an intermediate in heme synthesis. It is used as a PHOTOCHEMOTHERAPY for actinic KERATOSIS.

White or pink lesions on the arms, hands, face, or scalp that arise from sun-induced DNA DAMAGE to KERATINOCYTES in exposed areas. They are considered precursor lesions to superficial SQUAMOUS CELL CARCINOMA.

A lignan (LIGNANS) found in PODOPHYLLIN resin from the roots of PODOPHYLLUM plants. It is a potent spindle poison, toxic if taken internally, and has been used as a cathartic. It is very irritating to skin and mucous membranes, has keratolytic actions, has been used to treat warts and keratoses, and may have antineoplastic properties, as do some of its congeners and derivatives.

Caustic extract from the roots of Podophyllum peltatum and P. emodi. It contains PODOPHYLLOTOXIN and its congeners and is very irritating to mucous membranes and skin. Podophyllin is a violent purgative that may cause CNS damage and teratogenesis. It is used as a paint for warts, skin neoplasms, and senile keratoses.

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