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A Prospective Comparator Controlled Randomized Exploratory Study on the Efficacy of LAS 41005 Compared to Cryotherapy in Subjects With Hyperkeratotic Actinic Keratosis

Phase 2
18 Years
85 Years
Not Enrolling
Hyperkeratotic Actinic Keratosis

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Trial Information

A Prospective Comparator Controlled Randomized Exploratory Study on the Efficacy of LAS 41005 Compared to Cryotherapy in Subjects With Hyperkeratotic Actinic Keratosis


Inclusion Criteria:

- Signed and dated written informed consent.

- Men and women aged between 18 and 85 years inclusive.

- Have a general good and stable health condition as confirmed by a physical
examination and by medical history.

- Have at least 4 but not more than 10 clinically confirmed hyperkeratotic AK target
lesions of moderate to severe intensity within the face/forehead or bald scalp

- Skin type I to IV according to Fitzpatrick's .

- Are free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the
potential treatment area that may cause difficulty with examination or final

- Physical ability to apply the study preparation correctly and to follow the study
restrictions and visit.

- Women 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 treatment of AK within the treatment area (face / scalp) in the three
months preceding this clinical trial.

- Have known hypersensitivity to the ingredients

- Are subjects under immunosuppressive therapy.

- Having coagulation defects which are inherited or acquired

- Have evidence of clinically significant, unstable medical conditions

- Have currently other malignant or benign tumors of the skin within the treatment area

- Subjects who have taken topical or systemic treatments that might interfere with the
study end points, within a time window that is not allowed, or who are currently
taking phenytoin, methotrexate or sulfonylurea.

- Subjects taking inhibitors of DPD (e.g. Brivudin, Sorivudin)

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

- Have any dermatological disease in the treatment area or surrounding area that may be
exacerbated by treatment

- Are currently or within the past 8 weeks participating in another clinical study.

- Have active chemical dependency or alcoholism as assessed by the investigator.

- Subject is institutionalized because of legal or regulatory order.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Histological status (AK diagnosis and grade) of one predefined target lesion

Outcome Description:

Histological clearance at 8 weeks after end of treatment with LAS 41005, respectively 14 weeks after first cryotherapy. Histological Status will be measured by Histological Biopsy in order to confirm the diagnosis of AK and the grade.

Outcome Time Frame:

Screening and 8 weeks after last treatment

Safety Issue:


Principal Investigator

Rosario Rodríguez

Investigator Role:

Study Director

Investigator Affiliation:

Almirall, S.A.


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

H 1005 6002 1007



Start Date:

April 2011

Completion Date:

August 2012

Related Keywords:

  • Hyperkeratotic Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic