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LAS41005 in Hyperkeratotic Actinic Keratosis

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cryotherapy
LAS41005
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Almirall investigative site 3
  • Almirall investigative site 1
  • Almirall investigative site 4
  • Almirall investigative site 2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Drug Las41005

Cryotherapy

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
May 2, 2011
Last Updated
May 28, 2015
Sponsor
Almirall, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01358851
Brief Title
LAS41005 in Hyperkeratotic Actinic Keratosis
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Drug Las41005
Arm Title
2
Arm Type
Other
Arm Description
Cryotherapy
Intervention Type
Procedure
Intervention Name(s)
Cryotherapy
Intervention Description
1-2 times during the treatment time
Intervention Type
Drug
Intervention Name(s)
LAS41005
Intervention Description
once daily
Primary Outcome Measure Information:
Title
Histological status (AK diagnosis and grade) of one predefined target lesion
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.
Time Frame
Screening and 8 weeks after last treatment
Secondary Outcome Measure Information:
Title
Total Actinic keratoses (AK)lesion count at each visit
Description
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.
Time Frame
day 1, day 21, day 42 and day 98.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosario Rodríguez
Organizational Affiliation
Almirall, S.A.
Official's Role
Study Director
Facility Information:
Facility Name
Almirall investigative site 3
City
Dülmen
ZIP/Postal Code
48249
Country
Germany
Facility Name
Almirall investigative site 1
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Almirall investigative site 4
City
Soest
ZIP/Postal Code
59494
Country
Germany
Facility Name
Almirall investigative site 2
City
Wuppertal
ZIP/Postal Code
42275
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25257941
Citation
Simon JC, Dominicus R, Karl L, Rodriguez R, Willers C, Dirschka T. A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis. J Eur Acad Dermatol Venereol. 2015 May;29(5):881-9. doi: 10.1111/jdv.12702. Epub 2014 Sep 25.
Results Reference
derived

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LAS41005 in Hyperkeratotic Actinic Keratosis

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