LAS41005 in Hyperkeratotic Actinic Keratosis

NCT ID: NCT01358851

Last Updated: 2015-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-08-31

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).

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Drug Las41005

Group Type: EXPERIMENTAL

LAS41005

Intervention Type: DRUG

once daily

2

Cryotherapy

Group Type: OTHER

Cryotherapy

Intervention Type: PROCEDURE

1-2 times during the treatment time

Interventions

Cryotherapy

1-2 times during the treatment time

Intervention Type: PROCEDURE

LAS41005

once daily

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almirall, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosario Rodríguez

Role: STUDY_DIRECTOR

Almirall, S.A.

Locations

Almirall investigative site 3

Dülmen, , Germany

Almirall investigative site 1

Leipzig, , Germany

Almirall investigative site 4

Soest, , Germany

Almirall investigative site 2

Wuppertal, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 25257941 (View on PubMed)

Other Identifiers

H 1005 6002 1007

Identifier Type: -

Identifier Source: org_study_id