Clinical trial · Interventional
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
NCT00991861CI-TRIAL-00018082completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LAS106521 | Drug | — | UNRESOLVED |
| LAS41007 b.i.d. | Drug | — | UNRESOLVED |
| LAS41007 o.d. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- LAS41007 o.d.
- description
- Once daily
- interventionNames
- Drug: LAS41007 o.d.
- type
- EXPERIMENTAL
- label
- LAS41007 b.i.d.
- description
- Twice daily
- interventionNames
- Drug: LAS41007 b.i.d.
- type
- ACTIVE_COMPARATOR
- label
- LAS106521
- interventionNames
- Drug: LAS106521
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.