- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01611480
Efficacy and Safety of a New Topical Formulation With Imiquimod (Limtop) Applied 1, 3 or 7 Times Weekly During 2 x 2 Weeks Treatment for Actinic Keratosis on the Head
June 25, 2013 updated by: Moberg Pharma AB
The aim is to evaluate efficacy and safety of three different dosing regimens of Limtop in a study involving 96 patients with actinic keratosis on the head or face.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Germany, Germany
- 5 Locations
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent form (ICF) signed and dated by the patient prior to any study-related activity
- Male or female patients aged 18 or older
- Have a total of 5-20 clinically confirmed, palpable or visible (grade I or II according to modified Olsen score) nonhyperkeratotic, nonhypertrophic AK lesions located within a contiguous 25 - 100 cm² area on the balding scalp or face
- Any skin type or race, providing the skin pigmentation will allow discernment of erythema
- Willingness to actively participate in the study and to comply with the study procedures as defined in the study protocol
- High probability of a good compliance and orderly completion of the study
Negative urine pregnancy test (in female subjects with childbearing potential)
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Exclusion Criteria:
- Evidence of clinically significant, unstable cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease
- Diagnosed autoimmune diseases and anaemia
- Any dermatological disease and or condition in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination (e.g. rosacea, psoriasis, atopic dermatitis, eczema)
- Any significant findings (e.g. tattoos) in the potential application site area that may impair examination of treatment or surrounding area
- Confirmed squamous cell or basal cell carcinoma anywhere on the head in the past 3 months
- Share a household where there is a person participating in a concurrent clinical study of imiquimod or being treated with imiquimod 5% topical cream
- Active chemical dependency or alcoholism, as assessed by investigator
- Patients unwilling to stay out of the sun or wear protective clothing or to take appropriate measures to cover the treatment area during the study
- Previous treatments with imiquimod for AK in the predetermined treatment area within the past 3 months
- Treatment with COX-2 inhibitors 14 days prior to randomization
- Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization
- Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.
- Known allergy or sensitivity to imiquimod or any of the excipients (butyl lactate, isopropyl myristate, propylene glycol, butylated hydroxy anisole) in the IMP
Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who:
- are pregnant or nursing,
- are not surgically sterile,
- are of child bearing potential and not practicing an acceptable method of birth control, or does not plan to continue practicing an acceptable method of birth control throughout the trial (acceptable methods include intrauterine devices (IUD), oral, implantable or injectable contraceptives, diaphragm or cervical cap with intravaginal spermicide, condom with intravaginal spermicide or vasectomised partner)
- Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before Baseline
- Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry.
- Currently using or have used systemic steroids 2 months prior to study except inhaled corticosteroids (<1200 microgram/day for beclomethasone, or <600 microgram/day for fluticasone)
- Known infectious diseases (e.g. HIV, hepatitis)
- Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
- The Patient is institutionalized by virtue of an order issued either by the judicial or the administrative authorities
- Employee of the study site or of the Sponsor's company
- Any disease or circumstances on account of which the subject should not participate in the study in the opinion of the investigator -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
June 1, 2012
First Submitted That Met QC Criteria
June 4, 2012
First Posted (Estimate)
June 5, 2012
Study Record Updates
Last Update Posted (Estimate)
June 26, 2013
Last Update Submitted That Met QC Criteria
June 25, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIMTOP-I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Actinic Keratosis
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Dolorgiet GmbH & Co. KGd.s.h. statistical services GmbH; CenTrial GmbHCompletedActinic Keratosis Olsen Grade I/IIGermany
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Cosmetique Active InternationalNot yet recruiting
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Centre Dermatologique du RoyCompleted
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Encube Ethicals Pvt. Ltd.CBCC Global ResearchCompleted
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University of California, DavisActive, not recruiting
-
Northwestern UniversityWithdrawn
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Tulane UniversityMayne Pharma International Pty LtdTerminatedActinic KeratosesUnited States
-
Medical University of ViennaTerminatedActinic KeratosesAustria
-
University Hospital RegensburgGerman Research FoundationCompleted
-
St Vincent's University Hospital, IrelandCompleted
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Maruho Co., Ltd.Completed
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