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

Spirig Pharma

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: Resiquimod 0.03%; Drug: placebo; Drug: Resiquimod 0.01%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01583816

SP848-AK-1101

Details and patient eligibility

About

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

Full description

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).

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 5 patient groups

Resiquimod Gel 0.03% or placebo

Experimental group

Description:

Resiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once

Treatment:

Drug: placebo

Drug: Resiquimod 0.03%

Resiquimod or placebo

Experimental group

Description:

Once daily, 7x within 2 weeks, break of 8 weeks, cycle repeated once

Treatment:

Drug: placebo

Drug: Resiquimod 0.03%

Resiquimod or vehicle

Experimental group

Description:

Once daily, 5x for 1 week, break of 8 weeks, cycle repeated once

Treatment:

Drug: placebo

Drug: Resiquimod 0.03%

Resiquimod gel 0.01%

Experimental group

Description:

Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up

Treatment:

Drug: Resiquimod 0.01%

Resiquimod gel 0.03%

Experimental group

Description:

Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up

Treatment:

Drug: Resiquimod 0.03%