LAS41005 in Hyperkeratotic Actinic Keratosis

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358851
• Other study ID #: H 1005 6002 1007
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2011
• Last updated: May 28, 2015
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: May 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Procedure:
• Cryotherapy
1-2 times during the treatment time

Drug:
• LAS41005
once daily

Locations

Country	Name	City	State
Germany	Almirall investigative site 3	Dülmen
Germany	Almirall investigative site 1	Leipzig
Germany	Almirall investigative site 4	Soest
Germany	Almirall investigative site 2	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Screening and 8 weeks after last treatment	No
Secondary	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.	day 1, day 21, day 42 and day 98.	No