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Completed

NCT Number: NCT00987246

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

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

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Almirall Facility Site#37, Altenkirchen, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Have at least 4 but not more than 10 clinically confirmed AK target lesions of mild to moderate intensity within the face/forehead or bald scalp (excluding eyelids, lips, and mucosa), i.e. actinic keratosis grade I and II according to Olsen EA et al. 1991
  • Woman of childbearing potential are allowed to participate in this study only if they use a highly effective method of contraception

Main Exclusion Criteria:

  • Have received effective treatment of AK in the three months preceding this clinical trial
  • Have known hypersensitivity to LAS41005 or LAS106521
  • Have currently other malignant or benign tumors of the skin within the treatment area (e.g. malignant melanoma, basal cell carcinoma, squamous cell carcinoma)
  • Patient's taking phenytoin
  • Show cornu cutaneum like alterations of the skin in the face or the bald scalp (target area)

Treatment and study plan

Placebo Gel

Drug

Topical

LAS41005

Drug

Topical

LAS106521

Drug

Topical

Primary outcomes

  1. Histological status of AK target lesion

    Time frame: Day 140

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study title

Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 30, 2009
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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