Dose-finding, Safety, Efficacy Trial of Topical Resiquimod in Patients With Multiple Actinic Keratosis Lesions

Study Overview
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Brief Summary
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A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions

Detailed Description
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Prospective, randomized, partly blinded, in part placebo-controlled, multicenter dose-finding trial with patients suffering from AK. Patients were observed for efficacy, local tolerability and safety. A total of 14 sites in Switzerland and Germany enrolled male and female patients over 18 years of age with clinically diagnosed AK lesions Patients were randomized to receive resiquimod gel (Treatment Arms 1, 2, 3, 4, or 5) or matching vehicle (Treatment Arms 1-Pla, 2-Pla, or 3-Pla): Treatment Arms 1, 2 and 3: The patient was randomly assigned to one of three treatment groups and within each group there was one randomly assigned placebo patient for every two treatment patients (parallel-group randomization; 2:1 active vs placebo). Treatment Arms 4 and 5: The patient was randomly assigned to one of two treatment groups (parallel-group randomization, 1:1).

Official Title
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Prospective, Randomized, Partly Blinded, in Part Placebo-controlled, Multicenter, Dose-finding Trial Exploring Safety, Tolerability and Efficacy of a Topical Resiquimod Gel in Patients With Multiple Actinic Keratosis Lesions

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Resiquimod 0.03%
* Drug: Resiquimod 0.01%
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Male or nonpregnant, nonlactating female, ≥18 years A minimum of 2 clinically diagnosed AK-lesions within a defined area (25 cm2 contiguous treatment area). One AK-lesion must have a diameter of at least 6 mm (indicator lesion) AK-lesions on balding scalp, forehead or face Exclusion Criteria: Known allergy or hypersensitivity to any of the trial gel ingredients Dermatological disease or condition that might be exacerbated by resiquimod gel treatment or may impair trial assessments Evidence of unstable or uncontrolled clinically significant medical conditions, active infection, immunosuppression or systemic cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resiquimod Gel 0.03% or placebo<br>Resiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once | Drug: Resiquimod 0.03%<br>* topical application<br>Drug: placebo<br>* topical application<br>|
| Experimental: Resiquimod or placebo<br>Once daily, 7x within 2 weeks, break of 8 weeks, cycle repeated once | Drug: Resiquimod 0.03%<br>* topical application<br>Drug: placebo<br>* topical application<br>|
| Experimental: Resiquimod or vehicle<br>Once daily, 5x for 1 week, break of 8 weeks, cycle repeated once | Drug: Resiquimod 0.03%<br>* topical application<br>Drug: placebo<br>* topical application<br>|
| Experimental: Resiquimod gel 0.01%<br>Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up | Drug: Resiquimod 0.01%<br>* topical application<br>|
| Experimental: Resiquimod gel 0.03%<br>Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up | Drug: Resiquimod 0.03%<br>* topical application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with complete clinical clearance in the treated area at the end of trial |  | 8 weeks after a maximal treatment period of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adverse events (AEs) and serious adverse events (SAEs) |  | up to 24 weeks | 
| Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales |  | up to 24 weeks | 
| Number of patients with partial clearance |  | 8 weeks after a maximal treatment period of 8 weeks | 
| Evaluation of systemic tolerability [hematology, blood chemistry, vital signs] |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic Keratosis, Resiquimod