Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis

NCT00987246 | Completed Phase 3

• 2 other identifiers: H 1005 6002 - 0702EudraCT: 2007-003889-18
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 40

Brief Summary

The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis; AK; NMSC; Combination

Outcome Measures

Primary Outcomes (1)

• Histological status of AK target lesion

  Day 140

Study Arms (3)

LAS41005

EXPERIMENTAL

Drug: LAS41005

LAS106521

ACTIVE COMPARATOR

Drug: LAS106521

Placebo

PLACEBO COMPARATOR

Drug: Placebo Gel

Interventions

Placebo Gel DRUG

Topical

Placebo

LAS41005 DRUG

Topical

LAS41005

LAS106521 DRUG

Topical

LAS106521

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have at least 4 but not more than 10 clinically confirmed AK target lesions of mild to moderate intensity within the face/forehead or bald scalp (excluding eyelids, lips, and mucosa), i.e. actinic keratosis grade I and II according to Olsen EA et al. 1991
• Woman of childbearing potential are allowed to participate in this study only if they use a highly effective method of contraception

You may not qualify if:

• Have received effective treatment of AK in the three months preceding this clinical trial
• Have known hypersensitivity to LAS41005 or LAS106521
• Have currently other malignant or benign tumors of the skin within the treatment area (e.g. malignant melanoma, basal cell carcinoma, squamous cell carcinoma)
• Patient's taking phenytoin
• Show cornu cutaneum like alterations of the skin in the face or the bald scalp (target area)

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (40)

Almirall Facility Site#37

Altenkirchen, 57610, Germany

Location

Almirall Facility Site#24

Augsburg, 86163, Germany

Location

Almirall Facility Site#23

Augsburg, 86179, Germany

Location

Almirall Facility Site#01

Berlin, 10117, Germany

Location

Almirall Facility Site#28

Berlin, 10437, Germany

Location

Almirall Facility Site#02

Berlin, 10827, Germany

Location

Almirall Facility Site#34

Berlin, 10967, Germany

Location

Almirall Facility Site#35

Berlin, 12353, Germany

Location

Almirall Facility Site#31

Bonn, 53111, Germany

Location

Almirall Facility Site#04

Buxtehude, 21614, Germany

Location

Almirall Facility Site#40

Detmold, 32756, Germany

Location

Almirall Facility Site#30

Dresden, 01097, Germany

Location

Almirall Facility Site#11

Dülmen, 48249, Germany

Location

Almirall Facility Site#12

Düsseldorf, 40225, Germany

Location

Almirall Facility Site#17

Frankfurt, 60590, Germany

Location

Almirall Facility Site#22

Freiburg im Breisgau, 79104, Germany

Location

Almirall Facility Site#36

Friedrichshafen, 88045, Germany

Location

Almirall Facility Site#19

Fulda, 36037, Germany

Location

Almirall Facility Site#32

Göttingen, 37075, Germany

Location

Almirall Facility Site#09

Hamburg, 20148, Germany

Location

Almirall Facility Site#29

Jena, 07740, Germany

Location

Almirall Facility Site#07

Kiel, 24103, Germany

Location

Almirall Facility Site#08

Kiel, 24105, Germany

Location

Almirall Facility Site#15

Koblenz, 56068, Germany

Location

Almirall Facility Site#21

Landau, 76829, Germany

Location

Almirall Facility Site#27

Leipzig, 04103, Germany

Location

Almirall Facility Site#06

Lübeck, 23538, Germany

Location

Almirall Facility Site#03

Mahlow, 15831, Germany

Location

Almirall Facility Site#25

München, 80337, Germany

Location

Almirall Facility Site#39

München, 81476, Germany

Location

Almirall Facility Site#33

Nördlingen, 86720, Germany

Location

Almirall Facility Site#38

Osnabrück, 49078, Germany

Location

Almirall Facility Site#05

Pinneberg, 25421, Germany

Location

Almirall Facility Site#26

Quedlinburg, 06484, Germany

Location

Almirall Facility Site#20

Radolfzell, 78315, Germany

Location

Almirall Facility Site#10

Salzwedel, 29410, Germany

Location

Almirall Facility Site#16

Soest, 59494, Germany

Location

Almirall Facility Site#14

Vechta, 49377, Germany

Location

Almirall Facility Site#18

Wiesbaden, 65191, Germany

Location

Almirall Facility Site#13

Wuppertal, 42275, Germany

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Estrella Garcia, MD, MBA

  Almirall Hermal GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

DE (40)