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

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Placebo Gel

LAS41005

LAS106521

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, AK, NMSC, Combination

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

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

Main Exclusion Criteria:

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)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

LAS41005

LAS106521

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Histological status of AK target lesion

Secondary Outcome Measures

Full Information

NCT ID

NCT00987246

First Posted

September 29, 2009

Last Updated

July 27, 2015

Sponsor

Almirall, S.A.

1. Study Identification

Unique Protocol Identification Number

NCT00987246

Brief Title

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

Official Title

Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Almirall, S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

To investigate as primary objective: Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion; To investigate as secondary objective: Superiority to LAS106521 Improvement of treated lesions (lesion response) Assessment of tolerability and safety by physicians global assessment score (PGA, PGT) Patient's assessment of tolerability and efficacy and patient's compliance

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

Keywords

Actinic Keratosis, AK, NMSC, Combination

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

470 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LAS41005

Arm Type

Experimental

Arm Title

LAS106521

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo Gel

Intervention Description

Topical

Intervention Type

Drug

Intervention Name(s)

LAS41005

Intervention Description

Topical

Intervention Type

Drug

Intervention Name(s)

LAS106521

Intervention Description

Topical

Primary Outcome Measure Information:

Title

Histological status of AK target lesion

Time Frame

Day 140

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: 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 Main Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Estrella Garcia, MD, MBA

Organizational Affiliation

Almirall Hermal GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Almirall Facility Site#37

City

Altenkirchen

ZIP/Postal Code

57610

Country

Germany

Facility Name

Almirall Facility Site#24

City

Augsburg

ZIP/Postal Code

86163

Country

Germany

Facility Name

Almirall Facility Site#23

City

Augsburg

ZIP/Postal Code

86179

Country

Germany

Facility Name

Almirall Facility Site#01

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Almirall Facility Site#28

City

Berlin

ZIP/Postal Code

10437

Country

Germany

Facility Name

Almirall Facility Site#02

City

Berlin

ZIP/Postal Code

10827

Country

Germany

Facility Name

Almirall Facility Site#34

City

Berlin

ZIP/Postal Code

10967

Country

Germany

Facility Name

Almirall Facility Site#35

City

Berlin

ZIP/Postal Code

12353

Country

Germany

Facility Name

Almirall Facility Site#31

City

Bonn

ZIP/Postal Code

53111

Country

Germany

Facility Name

Almirall Facility Site#04

City

Buxtehude

ZIP/Postal Code

21614

Country

Germany

Facility Name

Almirall Facility Site#40

City

Detmold

ZIP/Postal Code

32756

Country

Germany

Facility Name

Almirall Facility Site#30

City

Dresden

ZIP/Postal Code

01097

Country

Germany

Facility Name

Almirall Facility Site#11

City

Dülmen

ZIP/Postal Code

48249

Country

Germany

Facility Name

Almirall Facility Site#12

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Almirall Facility Site#17

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Almirall Facility Site#22

City

Freiburg

ZIP/Postal Code

79104

Country

Germany

Facility Name

Almirall Facility Site#36

City

Friedrichshafen

ZIP/Postal Code

88045

Country

Germany

Facility Name

Almirall Facility Site#19

City

Fulda

ZIP/Postal Code

36037

Country

Germany

Facility Name

Almirall Facility Site#32

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Almirall Facility Site#09

City

Hamburg

ZIP/Postal Code

20148

Country

Germany

Facility Name

Almirall Facility Site#29

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Almirall Facility Site#07

City

Kiel

ZIP/Postal Code

24103

Country

Germany

Facility Name

Almirall Facility Site#08

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Almirall Facility Site#15

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Almirall Facility Site#21

City

Landau

ZIP/Postal Code

76829

Country

Germany

Facility Name

Almirall Facility Site#27

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Almirall Facility Site#06

City

Lübeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Almirall Facility Site#03

City

Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

Almirall Facility Site#25

City

München

ZIP/Postal Code

80337

Country

Germany

Facility Name

Almirall Facility Site#39

City

München

ZIP/Postal Code

81476

Country

Germany

Facility Name

Almirall Facility Site#33

City

Nördlingen

ZIP/Postal Code

86720

Country

Germany

Facility Name

Almirall Facility Site#38

City

Osnabrück

ZIP/Postal Code

49078

Country

Germany

Facility Name

Almirall Facility Site#05

City

Pinneberg

ZIP/Postal Code

25421

Country

Germany

Facility Name

Almirall Facility Site#26

City

Quedlinburg

ZIP/Postal Code

06484

Country

Germany

Facility Name

Almirall Facility Site#20

City

Radolfzell

ZIP/Postal Code

78315

Country

Germany

Facility Name

Almirall Facility Site#10

City

Salzwedel

ZIP/Postal Code

29410

Country

Germany

Facility Name

Almirall Facility Site#16

City

Soest

ZIP/Postal Code

59494

Country

Germany

Facility Name

Almirall Facility Site#14

City

Vechta

ZIP/Postal Code

49377

Country

Germany

Facility Name

Almirall Facility Site#18

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Almirall Facility Site#13

City

Wuppertal

ZIP/Postal Code

42275

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.almirall.com/webcorp2/cda/ImD_04_02.jsp

Description

Sponsor website

Learn more about this trial

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

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

Actinic Keratosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial