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Double-blind, Randomized, Vehicle- and Comparator-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of LAS41007 in the Treatment of Actinic Keratosis

Phase 3
18 Years
Not Enrolling
Actinic Keratosis

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Trial Information

Double-blind, Randomized, Vehicle- and Comparator-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of LAS41007 in the Treatment of Actinic Keratosis

Inclusion Criteria:

- Have at least 6 but not more than 16 clinically confirmed AK target lesions of mild
to moderate (grade I to II, according to Olsen et al., 1991) intensity in the whole
treatment area (TA) (and additionally one representative AK lesion for histological
diagnosis of AK), which must be located in the face including the forehead (excluding
eyelids, lips and mucosa) and/or bald scalp,

- The AK target lesions must be discrete and quantifiable; the distance from one lesion
to its neighbor lesion must be greater than 1.0 cm,

- The diameter of each AK target lesion should be not less than 0.5 cm and not greater
than 1.5 cm,

- The target lesions must be located in up to 3 TAs with a size of 25 cm2 per TA (i.e.
total area of TA is up to 75 cm2),

- Diagnosis of AK histologically confirmed

Exclusion Criteria:

- Have known hypersensitivity, intolerance or allergies against ingredients of the IMPs
and other non-steroidal anti-inflammatory agents,

- Have a history of bronchospasm, asthma, urticaria, or rhinitis after the intake of
non-steroidal anti-inflammatory drugs (NSAIDs),

- Have a history of gastrointestinal bleeding or perforation associated with prior
therapy with NSAIDs,

- Have evidence of clinically significant or unstable medical conditions,

- Have currently and within the past 3 months other malignant tumors of the skin in the

- Suffer from paresthesia in the TAs,

- Show cornu cutaneum of the skin and/or hypertrophic AK lesions in the TAs,

- Are known to be pregnant or lactating (currently or within the past 3 months),

- Any clinically relevant abnormal finding during Screening and/or Baseline,

- Specific topical treatments in the target area within defined time periods.

- Specific physical treatments in the TAs within defined time periods.

- Specific systemic treatments within defined time periods.

- Patients suffering from AK in locations other than the target areas, receiving any
topical AK-therapy throughout the interventional phase of the study until termination
of V6,

- Patients who need a permanent therapy with any other NSAID. The use of NSAIDs as
"prn" (pro re nata), i.e. to be taken as needed (≤ 3 days at a stretch) and the use
of ASA as anticoagulative therapy will be allowed,

- Patients taking methotrexate or sulfonylurea during the interventional phase of the

- Anticoagulative therapy, e.g. with cumarines or heparines throughout the
interventional phase of the study. Treatment with ASA at a dose not exceeding 100
mg/d and clopidogrel at a dose not exceeding 75 mg/d will be allowed,

- Patients having any significant physical abnormalities in the potential TAs that may
cause difficulty with examination or final evaluation,

- Have any dermatological disease in the TAs or surrounding area that may be
exacerbated by treatment with topical diclofenac or cause difficulty with

- Physical or mental inability and/or unwillingness to apply the study preparations
correctly and to follow the study restrictions and visits,

- Any suspicion of current drug and/or alcohol abuse as assessed by the investigator,

- Anticipated non-availability for study visits / procedures,

- Exposure to an investigational product within the last 3 months,

- Any previous randomization into this trial,

- Patient is institutionalized because of legal or regulatory order,

- Employee of the study site or of the Sponsor's company or the CRO.

Type of Study:


Study Design:

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

Outcome Measure:

superiority of LAS41007 compared to vehicle

Outcome Description:

superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion

Outcome Time Frame:

Day 1

Safety Issue:


Principal Investigator

Dr. Estrella Estrella Garcia, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Almirall, S.A.


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

H 569 000 - 1004



Start Date:

November 2010

Completion Date:

March 2012

Related Keywords:

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