Dose-finding Trial Exploring Safety, Tolerability and Efficacy of a Topical Resiquimod Gel in Patients With Multiple Actinic Keratosis Lesions
This study is currently recruiting participants.
Verified May 2013 by Spirig Pharma Ltd.
Sponsor:
Spirig Pharma Ltd.
Information provided by (Responsible Party):
Spirig Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01583816
First received: April 18, 2012
Last updated: May 29, 2013
Last verified: May 2013
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Purpose
A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions
| Condition | Intervention | Phase |
|---|---|---|
|
Actinic Keratosis |
Drug: Resiquimod Drug: Placebo / Vehicle |
Phase 2 |
| Study Type: | 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 |
| Official Title: | 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 |
Further study details as provided by Spirig Pharma Ltd.:
Primary Outcome Measures:
- Number of patients with complete clinical clearance in the treated area at the end of trial [ Time Frame: 8 weeks after a maximal treatment period of 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluation of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
- Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
- Number of patients with partial clearance [ Time Frame: 8 weeks after a maximal treatment period of 8 weeks ] [ Designated as safety issue: No ]
- Evaluation of systemic tolerability [hematology, blood chemistry, vital signs] [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 208 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Resiquimod Gel |
Drug: Resiquimod
0.03% Resiquimod Topical Gel
|
| Placebo Comparator: Placebo Gel |
Drug: Placebo / Vehicle
Placebo Topical Gel
|
| Experimental: Resiquimod Gel - BioEP - 1 |
Drug: Resiquimod
0.01% Resiquimod Topical Gel
|
| Experimental: Resiquimod Gel - BioEP - 2 |
Drug: Resiquimod
0.03% Resiquimod Topical Gel
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583816
Contacts
| Contact: Robert Kenzelmann, MD | Robert.Kenzelmann@spirig.ch | |
| Contact: Christian Paratore, PhD | christian.paratore@spirig.ch |
Locations
| Germany | |
| Hauttumorcentrum Charité (HTCC) | Recruiting |
| Berlin, Germany | |
| Medizinisches Zentrum Bonn - Friedensplatz | Recruiting |
| Bonn, Germany | |
| Hautzentrum | Recruiting |
| Düsseldorf, Germany | |
| Johannes Wesling Klinikum Minden | Recruiting |
| Minden, Germany | |
| KLINIKUM VEST GmbH Knappschaftskrankenhaus | Recruiting |
| Recklinghausen, Germany | |
| Switzerland | |
| Kantonsspital Aarau | Active, not recruiting |
| Aarau, Switzerland | |
| Universitätsspital Basel | Recruiting |
| Basel, Switzerland | |
| Inselspital | Recruiting |
| Bern, Switzerland | |
| Kantonsspital St.Gallen | Recruiting |
| St. Gallen, Switzerland | |
| Universitaetsspital Zurich | Recruiting |
| Zurich, Switzerland | |
Sponsors and Collaborators
Spirig Pharma Ltd.
Investigators
| Principal Investigator: | Lars E French, MD | University Clinic of Dermatology, Zurich |
More Information
No publications provided
| Responsible Party: | Spirig Pharma Ltd. |
| ClinicalTrials.gov Identifier: | NCT01583816 History of Changes |
| Other Study ID Numbers: | SP848-AK-1101 |
| Study First Received: | April 18, 2012 |
| Last Updated: | May 29, 2013 |
| Health Authority: | Switzerland: Ethikkommission Switzerland: Swissmedic Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Spirig Pharma Ltd.:
|
Actinic Keratosis Resiquimod |
Additional relevant MeSH terms:
|
Keratosis Keratosis, Actinic Skin Diseases Precancerous Conditions Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013