LAS41005 in Hyperkeratotic Actinic Keratosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01358851
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
Almirall, S.A.

Brief Summary:
The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies).

Condition or disease Intervention/treatment Phase
Actinic Keratosis Procedure: Cryotherapy Drug: LAS41005 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Comparator Controlled Randomized Exploratory Study on the Efficacy of LAS 41005 Compared to Cryotherapy in Subjects With Hyperkeratotic Actinic Keratosis
Study Start Date : April 2011
Primary Completion Date : March 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug Las41005
Drug: LAS41005
once daily
Procedure: Cryotherapy
1-2 times during the treatment time

Primary Outcome Measures :
  1. Histological status (AK diagnosis and grade) of one predefined target lesion [ Time Frame: Screening and 8 weeks after last treatment ]
    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.

Secondary Outcome Measures :
  1. Total Actinic keratoses (AK)lesion count at each visit [ Time Frame: day 1, day 21, day 42 and day 98. ]
    The clearance rate (complete/partial) of AK lesions (determined by clinical evaluation) in the treatment area (target areas A and B) will be measured by comparing the total AK lesion counts pre-treatment (on Day 1 before study treatment has been applied) with the lesion counts measured.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main 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 evaluation.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01358851

Almirall investigative site 3
Dülmen, Germany, 48249
Almirall investigative site 1
Leipzig, Germany, 04107
Almirall investigative site 4
Soest, Germany, 59494
Almirall investigative site 2
Wuppertal, Germany, 42275
Sponsors and Collaborators
Almirall, S.A.
Study Director: Rosario Rodríguez Almirall, S.A.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Almirall, S.A. Identifier: NCT01358851     History of Changes
Other Study ID Numbers: H 1005 6002 1007
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions