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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00991861

Enrollment

100

Registered

2009-10-08

Start date

2009-08-31

Completion date

2010-02-28

Last updated

2015-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis, AK, NMSC

Brief 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.

Interventions

DRUGLAS41007 o.d.

Once daily, topical application

DRUGLAS41007 b.i.d.

Twice daily, topical application

DRUGLAS106521

Twice daily, topical application

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Histological clearance of one pre-selected target lesion	Day 120
Complete clinical clearance of all target lesions in the treatment areas	Day 120

Secondary

Measure	Time frame
Physician's Global Tolerability Assessment (PGT)	Day 120

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026