Actinic KeratosisPhase 2NCT01611480
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
A Phase 2 study testing Imiquimod (topical use) in people with Actinic Keratosis, run by Moberg Pharma AB at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Imiquimod (topical use)
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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)
- -
Who cannot join
- 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
Show all 25Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Actinic Keratosis
- Being tested
- Imiquimod (topical use)
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod (topical use)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
Sponsor and investigators
- Lead sponsor
- Moberg Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611480
- Sponsor's protocol ID
- LIMTOP-I
- Status last verified
- Jun 2013
- First submitted
- 1 Jun 2012
- Last updated
- 26 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01611480
- Acronym / sponsor ID
- LIMTOP-I
- Conditions
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Moberg Pharma ABIndustry (pharma, biotech, devices)
- Primary completion
- Jan 2013 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imiquimod (topical use) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imiquimod (topical use) in people with Actinic Keratosis, run by Moberg Pharma AB at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.