Double-blind, Randomized, Vehicle- and Comparator-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of LAS41007 in the Treatment of Actinic Keratosis

NCT01265602 | Completed Phase 3

• 1 other identifier: H 569 000 - 1004
• Study Type: interventional
• Target: 889
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the efficacy, safety and tolerability of LAS41007 compared to a marketed reference product as well as to vehicle (topical application, twice daily, indication mild to moderate AK).

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis; AK; NMSC

Outcome Measures

Primary Outcomes (2)

• superiority of LAS41007 compared to vehicle

  superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion

  Day 1

• superiority of LAS41007 compared to vehicle

  superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion

  Day 150

Secondary Outcomes (5)

• superiority of LAS41007 compared to vehicle

  Day 1

• superiority of LAS41007 compared to vehicle

  Day 21

• superiority of LAS41007 compared to vehicle

  Day 56

• superiority of LAS41007 compared to vehicle

  Day 90

• superiority of LAS41007 compared to vehicle

  Day 150

Study Arms (3)

LAS41007

EXPERIMENTAL

All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum.

Drug: LAS41007

LASW1510

ACTIVE COMPARATOR

All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum.

Drug: LASW1510

vehicle

PLACEBO COMPARATOR

All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum.

Drug: vehicle of LAS41007

Interventions

LAS41007 DRUG

Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².

LAS41007

LASW1510 DRUG

Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².

LASW1510

vehicle of LAS41007 DRUG

Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².

vehicle

Eligibility Criteria

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

You may qualify if:

• Have at least 6 but not more than 16 clinically confirmed AK target lesions of mild to moderate (grade I to II, according to Olsen et al., 1991) intensity in the whole treatment area (TA) (and additionally one representative AK lesion for histological diagnosis of AK), which must be located in the face including the forehead (excluding eyelids, lips and mucosa) and/or bald scalp,
• The AK target lesions must be discrete and quantifiable; the distance from one lesion to its neighbor lesion must be greater than 1.0 cm,
• The diameter of each AK target lesion should be not less than 0.5 cm and not greater than 1.5 cm,
• The target lesions must be located in up to 3 TAs with a size of 25 cm2 per TA (i.e. total area of TA is up to 75 cm2),
• Diagnosis of AK histologically confirmed

You may not qualify if:

• Have known hypersensitivity, intolerance or allergies against ingredients of the IMPs and other non-steroidal anti-inflammatory agents,
• Have a history of bronchospasm, asthma, urticaria, or rhinitis after the intake of non-steroidal anti-inflammatory drugs (NSAIDs),
• Have a history of gastrointestinal bleeding or perforation associated with prior therapy with NSAIDs,
• Have evidence of clinically significant or unstable medical conditions,
• Have currently and within the past 3 months other malignant tumors of the skin in the TAs,
• Suffer from paresthesia in the TAs,
• Show cornu cutaneum of the skin and/or hypertrophic AK lesions in the TAs,
• Are known to be pregnant or lactating (currently or within the past 3 months),
• Any clinically relevant abnormal finding during Screening and/or Baseline,
• Specific topical treatments in the target area within defined time periods.
• Specific physical treatments in the TAs within defined time periods.
• Specific systemic treatments within defined time periods.
• Patients suffering from AK in locations other than the target areas, receiving any topical AK-therapy throughout the interventional phase of the study until termination of V6,
• Patients who need a permanent therapy with any other NSAID. The use of NSAIDs as "prn" (pro re nata), i.e. to be taken as needed (≤ 3 days at a stretch) and the use of ASA as anticoagulative therapy will be allowed,
• Patients taking methotrexate or sulfonylurea during the interventional phase of the study,

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

Almirall Investigational Site

Vechta, 49377, Germany

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Estrella Estrella Garcia, PhD

  Almirall, S.A.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 23, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

DE (1)