Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis

Actinic Keratosis Clinical Trial

Official title:

Double-blind, Randomized, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41007 Once Daily and LAS41007 Twice Daily Versus LAS106521 Gel Twice Daily in the Treatment of Actinic Keratosis Grade I to II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991861
• Other study ID #: H 569 000 - 0908
• Secondary ID: EudraCT: 2009-01
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2009
• Last updated: May 28, 2015
• Start date: August 2009
• Est. completion date: February 2010

Study information

• Verified date: May 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 4-10 clinically assessed actinic keratosis grade I to II (according to Olsen et al, 1991) in the face/forehead and/or on the bald scalp

• The diameter of each AK target lesion is not less than 0.5 cm and not greater than 1.5 cm

• The target lesions must be located in overall 2 treatment areas with a size of 25 cm2 per treatment area

Exclusion Criteria:

• Have evidence of clinically significant or unstable medical conditions such as:

• metastatic tumor or tumor with high probability of metastatic spread

• heart failure (NYHA class III or higher)

• immunosuppressive disorder (e.g. HIV)

• hematologic, hepatic, renal, neurologic or endocrine disorder.

• collagen-vascular disorder (e.g. cerebrovascular disorder or other bleedings).

• gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage)

• Suffer from paresthesia in the treatment areas

• Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• LAS41007 o.d.
Once daily, topical application
• LAS41007 b.i.d.
Twice daily, topical application
• LAS106521
Twice daily, topical application

Locations

Country	Name	City	State
Germany	Investigational Site	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological clearance of one pre-selected target lesion		Day 120	No
Primary	Complete clinical clearance of all target lesions in the treatment areas		Day 120	No
Secondary	Physician's Global Tolerability Assessment (PGT)		Day 120	Yes

External Links

•   Almirall Corporate Website