Clinical trial NCT01358851: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Histological status (AK diagnosis and grade) of one predefined target lesion
timeFrame: Screening and 8 weeks after last treatment
Secondary outcomes:
measure: Total Actinic keratoses (AK)lesion count at each visit
timeFrame: day 1, day 21, day 42 and day 98.
Other outcomes:
Locations:
city: Dülmen
country: Germany
facility: Almirall investigative site 3
city: Leipzig
country: Germany
facility: Almirall investigative site 1
city: Soest
country: Germany
facility: Almirall investigative site 4
city: Wuppertal
country: Germany
facility: Almirall investigative site 2
Study officials:
affiliation: Almirall, S.A.
name: Rosario Rodríguez
role: STUDY_DIRECTOR
References:
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.