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Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses

2014-08-27 03:42:34 | BioPortfolio

Summary

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

Description

Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Actinic Keratosis

Intervention

PEP005

Location

Medical Affiliated Research Center, Inc.
303 Williams Ave, Suite 512, Huntsville
Alabama
United States
35801

Status

Completed

Source

Peplin

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:34-0400

Clinical Trials [127 Associated Clinical Trials listed on BioPortfolio]

Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies

This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month pe...

A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or ...

A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study

This study is designed to follow up patients, who have participated in the PEP005-028 study and observed complete clearance of their Actinic Keratosis (AK) lesions, over a 12 month period ...

A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.

PubMed Articles [72 Associated PubMed Articles listed on BioPortfolio]

Validity and Reliability of the Dutch Adaptation of the Actinic Keratosis Quality of Life Questionnaire (AKQoL).

The Actinic Keratosis Quality of Life Questionnaire (AKQoL) is a disease-specific instrument to measure the impact of actinic keratosis (AK) on patients' lives.

Swiss (German) Version of the Actinic Keratosis Quality of Life questionnaire.

Actinic keratosis (AK) is a sun-induced skin lesion that may progress to invasive squamous cell carcinoma of the skin. Recently, the Actinic Keratosis Quality of Life questionnaire (AKQoL) was designe...

Diclofenac Sodium 3% in Hyaluronic Acid 2.5% Gel Significantly Diminishes the Actinic Keratosis Area and Severity Index.

Actinic keratosis area and severity index (AKASI) is a new assessment tool to quantify the severity of actinic damage on the head. Thus far, it has not been evaluated in monitoring the efficacy of fie...

A randomized split-scalp study comparing Calcipotriol assisted MAL-PDT with Conventional MAL-PDT for the treatment of Actinic Keratosis.

Topical photodynamic therapy (PDT) is an approved treatment for actinic keratosis (AK). To enhance the efficacy of PDT for AKs, physical (ablative lasers and microneedling) and chemical (pro-different...

Impact of Topical Fluorouracil Cream on Costs of Treating Keratinocyte Carcinoma (Nonmelanoma Skin Cancer) and Actinic Keratosis.

It is unknown whether treatment costs of Keratinocyte Carcinoma (KC) and Actinic Keratosis (AK) can be lowered by spending more on chemoprevention.

Medical and Biotech [MESH] Definitions

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.

Any horny growth such as a wart or callus.

Benign eccrine poromas that present as multiple oval, brown-to-black plaques, located mostly on the chest and back. The age of onset is usually in the fourth or fifth decade.

A heritable disorder of faulty keratinization characterized by the proliferation of abnormal clones of KERATINOCYTES and lesions showing varying atrophic patches surrounded by an elevated, keratotic border. These keratotic lesions can progress to overt cutaneous neoplasm. Several clinical variants are recognized, including porokeratosis of Mibelli, linear porokeratosis, disseminated superficial actinic porokeratosis, palmoplantar porokeratosis, and punctate porokeratosis.

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