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

Phase 2

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: LAS41007 o.d.; Drug: LAS106521; Drug: LAS41007 b.i.d.

• Registration Number: NCT00991861
• Lead Sponsor: Almirall, S.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-08
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAS41007 o.d.	LAS41007 o.d.	Once daily
LAS106521	LAS106521	-
LAS41007 b.i.d.	LAS41007 b.i.d.	Twice daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Physician's Global Tolerability Assessment (PGT)	Day 120

Trial Locations

Locations (1)

Investigational Site; 🇩🇪 Hamburg, Germany