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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Number of patients with complete clinical clearance in the treated area at the end of trial

Outcome Time Frame:

8 weeks after a maximal treatment period of 8 weeks

Safety Issue:

No

Principal Investigator

Lars E French, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Clinic of Dermatology, Zurich

Authority:

Switzerland: Ethikkommission

Study ID:

SP848-AK-1101

NCT ID:

NCT01583816

Start Date:

May 2012

Completion Date:

March 2014

Related Keywords:

  • Actinic Keratosis
  • Actinic Keratosis
  • Resiquimod
  • Keratosis
  • Keratosis, Actinic

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