Trial | NCT01583816  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    resiquimod ...

  • Study Participants

    218
A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions
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).
Study Started
May 31
2012
Primary Completion
Nov 30
2013
Study Completion
Jun 30
2014
Last Update
Dec 15
2015
Estimate

Drug Resiquimod 0.03%

topical application

Drug Resiquimod 0.01%

topical application

Drug placebo

topical application

Resiquimod Gel 0.03% or placebo Experimental

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

Resiquimod or placebo Experimental

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

Resiquimod or vehicle Experimental

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

Resiquimod gel 0.01% Experimental

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

Resiquimod gel 0.03% Experimental

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

Criteria 

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
No Results Posted