LAS41005 in Hyperkeratotic Actinic Keratosis | NCT01358851

NCT01358851

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
1	Experimental	Drug Las41005	Drug: LAS41005
2	Other	Cryotherapy	Procedure: Cryotherapy

Name	Type	Description	Arm Group Labels	Other Names
Cryotherapy	Procedure	1-2 times during the treatment time	2
LAS41005

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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.

Name	Affiliation	Role
Rosario Rodríguez	Almirall, S.A.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Almirall investigative site 3		Dülmen		48249	Germany
Almirall investigative site 1

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25257941	Derived	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.