LAS41005 in Hyperkeratotic Actinic Keratosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01358851
First received: May 2, 2011
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Hyperkeratotic Actinic Keratosis
Procedure: Cryotherapy
Drug: LAS41005
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Histological status (AK diagnosis and grade) of one predefined target lesion [ Time Frame: Screening and 8 weeks after last treatment ] [ Designated as safety issue: No ]
    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:
  • Total Actinic keratoses (AK)lesion count at each visit [ Time Frame: day 1, day 21, day 42 and day 98. ] [ Designated as safety issue: No ]
    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.


Enrollment: 67
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug Las41005
Drug: LAS41005
once daily
2
Cryotherapy
Procedure: Cryotherapy
1-2 times during the treatment time

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358851

Locations
Germany
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.
Investigators
Study Director: Rosario Rodríguez Almirall, S.A.
  More Information

No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01358851     History of Changes
Other Study ID Numbers: H 1005 6002 1007
Study First Received: May 2, 2011
Last Updated: January 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 16, 2014