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Completed

NCT Number: NCT00991861

Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis

The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site

Hamburg, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 4-10 clinically assessed actinic keratosis grade I to II (according to Olsen et al, 1991) in the face/forehead and/or on the bald scalp
  • The diameter of each AK target lesion is not less than 0.5 cm and not greater than 1.5 cm
  • The target lesions must be located in overall 2 treatment areas with a size of 25 cm2 per treatment area

Exclusion criteria

  • Have evidence of clinically significant or unstable medical conditions such as:
  • metastatic tumor or tumor with high probability of metastatic spread
  • heart failure (NYHA class III or higher)
  • immunosuppressive disorder (e.g. HIV)
  • hematologic, hepatic, renal, neurologic or endocrine disorder.
  • collagen-vascular disorder (e.g. cerebrovascular disorder or other bleedings).
  • gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage)
  • Suffer from paresthesia in the treatment areas
  • Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas

Treatment and study plan

LAS41007 o.d.

Drug

Once daily, topical application

LAS41007 b.i.d.

Drug

Twice daily, topical application

LAS106521

Drug

Twice daily, topical application

Primary outcomes

  1. Histological clearance of one pre-selected target lesion

    Time frame: Day 120

  2. Complete clinical clearance of all target lesions in the treatment areas

    Time frame: Day 120

Secondary outcomes

  1. Physician's Global Tolerability Assessment (PGT)

    Time frame: Day 120

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study title

Double-blind, Randomized, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41007 Once Daily and LAS41007 Twice Daily Versus LAS106521 Gel Twice Daily in the Treatment of Actinic Keratosis Grade I to II

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 8, 2009
Registry last updated
May 29, 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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