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Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis

2014-08-27 03:18:58 | BioPortfolio

Summary

The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).

Description

To investigate as primary objective:

- Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion;

To investigate as secondary objective:

- Superiority to LAS106521

- Improvement of treated lesions (lesion response)

- Assessment of tolerability and safety by physicians global assessment score (PGA, PGT)

- Patient's assessment of tolerability and efficacy and patient's compliance

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Actinic Keratosis

Intervention

Placebo Gel, LAS41005, LAS106521

Status

Completed

Source

Almirall, S.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:58-0400

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PubMed Articles [972 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.

Incidence of Actinic Keratosis and Risk of Skin Cancer in Subjects with Actinic Keratosis: A Population-based Cohort Study.

In vivo Confocal Laser Microscopy for monitoring of actinic keratosis treatment: a comparison with histopathologic assessment after treatment with topical 5% 5-fluorouracil.

Histological examination is the gold standard for actinic keratosis diagnosis; however, it is not always a feasible approach. Reflectance confocal microscopy (RCM) is a non-invasive technique that may...

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...

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.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Any horny growth such as a wart or callus.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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