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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Histological clearance of one pre-selected target lesion

Outcome Time Frame:

Day 120

Safety Issue:

No

Principal Investigator

Christoph Willers, MD, MBA

Investigator Role:

Study Director

Investigator Affiliation:

Almirall Hermal GmbH

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

H 569 000 - 0908

NCT ID:

NCT00991861

Start Date:

August 2009

Completion Date:

February 2010

Related Keywords:

  • Actinic Keratosis
  • Actinic Keratosis
  • AK
  • NMSC
  • Keratosis
  • Keratosis, Actinic

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