Lentigo MalignaPhase 4LIMIT-1NCT01161888
Effect of Topical Imiquimod on Lentigo Maligna
A Phase 4 study testing Imiquimod in people with Lentigo Maligna, run by Jerry Marsden at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine if topical imiquimod is effective in the pathological complete regression of lentigo maligna. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Lentigo Maligna
- What is being tested?
- Imiquimod
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Mar 2012
- Phase
- Phase 4
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of lentigo maligna (LM) (acquired pigmented macule present for more than 12 months with no change in skin surface texture or contour, no palpability, diameter >10 mm, sited on the head or neck). The lower anatomical limit is the root of the neck - a line joining the medial end of the clavicles with the medial insertion of trapezius.
- Histological findings consistent with LM (increased numbers of atypical melanocytes confined to the epidermis, sun damaged skin) in one or more 4mm punch biopsies(s) from the darkest area, reported by a pathologist with expertise in the diagnosis of melanocytic lesions, and part of a recognised NHS skin cancer Multi-Disciplinary Team.
- The upper limit of the lesion is not defined by size, but it must be suitable for complete surgical excision using a 5 mm lateral margin.
- The outline of the lesion must be easily defined visually in daylight around its entire circumference.
- Patient fit enough and willing to undergo surgery as required by the protocol.
Who cannot join
- Clinical or histological evidence of invasive melanoma including any palpability of the lesion, or clinical and/or histological evidence of regression or dermal invasion
- Aged less than 45 years
- Recurrent LM - the index lesion must not have been previously treated
- Life expectancy of less than 12 months
- Other skin lesions which may compromise the ability to complete this study, such as co-existing or adjacent melanoma or non-melanoma skin cancer. Co-existing adjacent actinic keratoses would not exclude the patient from the study
- Women of childbearing potential, who are pregnant, plan to become pregnant during their study participation or breastfeeding.
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- Unable to give informed consent.
- Hypersensitivity to imiquimod or to any of the excipients (methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetyl alcohol and stearyl alcohol).
- Taking immunosuppressive medication.
- Taking part in any other intervention study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dr J Marsden
Queen Elizabeth Hospital, Birmingham, B15 2TH
About this study
The purpose of this study is to determine if topical imiquimod is effective in the pathological complete regression of lentigo maligna.
- Conditions
- Lentigo Maligna
- Being tested
- Imiquimod
- Medical subject headings
- Hutchinson's Melanotic Freckle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
Also called Aldara 5% cream
250mg sachets to be applied at a start dose of 5 days a week. Dose will be adjusted using an algorithm according to tolerability.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete regression (PCR) in the mapped biopsied and resected LM using 2 mm slices.
Measured: Results available at 1-2 week post surgery follow up visit.
Secondary outcomes (5)
Clinical assessment of response after imiquimod treatment
The pathological response in the entire resected lesion will be compared with that predicted from clinical examination and biopsies taken before surgery, post imiquimod treatment. We will assess whether adequate surgical margins can be determined using clinical maps. It is essential to know the accuracy of the method of clinical assessment of response.
Measured: Assessed at 12 week treatment visit and 1-2 week post surgery follow up
Clinical feasibility of imiquimod treatment
Number of reported local adverse reactions and systemic adverse reactions; adherence to treatment schedule and acceptability of imiquimod treatment.
Measured: Tolerability will be assessed during treatment period of 12 weeks
Number of consultations with NHS staff during imiquimod treatment
Measured: Assessed up to week 12 visit
Frequency of functional T cell responses recognising peptide epitopes in melanocyte differentiation and cancer-testis antigens.
Circulating immune responses to proteins expressed within melanoma will be measured using blood draws taken before imiquimod treatment and after completion of imiquimod therapy but before surgery. The demonstration of a circulating immune response would be an important finding that would strongly support the investigation of imiquimod as primary therapy for melanoma, even if coupled with subsequent surgery because of the potential for such an immune response to be preventative against recurrence or invasive disease.
Measured: Assessed with baseline and 12 week visit samples.
Measurement of hypothetical treatment preferences for surgery or imiquimod for LM using standard gamble technique.
Measured: Questionnaire completed at 12 weeks post surgery (follow up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lentigo MalignaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jerry Marsden
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, United Kingdom
- Responsible party
- Sponsor-investigator, Jerry Marsden, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Jerry Marsden, Dr, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161888
- Sponsor's protocol ID
- LIMIT-1
- Acronym
- LIMIT-1
- Status last verified
- May 2010
- First submitted
- 24 Jun 2010
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Imiquimod on Lentigo Maligna
- ClinicalTrials.gov ID
- NCT01161888
- Acronym / sponsor ID
- LIMIT-1 / LIMIT-1
- Conditions
- Lentigo Maligna
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jerry MarsdenUniversity, hospital or other
- Collaborators
- Department of Health, United Kingdom
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Jul 2010 (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 purpose of this study is to determine if topical imiquimod is effective in the pathological complete regression of lentigo maligna.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of lentigo maligna (LM) (acquired pigmented macule present for more than 12 months with no change in skin surface texture or contour, no palpability, diameter >10 mm, sited on the head or neck). The lower anatomical limit is the root of the neck - a line joining the medial end of the clavicles with the medial insertion of trapezius.
- Histological findings consistent with LM (increased numbers of atypical melanocytes confined to the epidermis, sun damaged skin) in one or more 4mm punch biopsies(s) from the darkest area, reported by a pathologist with expertise in the diagnosis of melanocytic lesions, and part of a recognised NHS skin cancer Multi-Disciplinary Team.
- The upper limit of the lesion is not defined by size, but it must be suitable for complete surgical excision using a 5 mm lateral margin.
- The outline of the lesion must be easily defined visually in daylight around its entire circumference.
- Patient fit enough and willing to undergo surgery as required by the protocol.
Key exclusion criteria (10 listed)
- Clinical or histological evidence of invasive melanoma including any palpability of the lesion, or clinical and/or histological evidence of regression or dermal invasion
- Aged less than 45 years
- Recurrent LM - the index lesion must not have been previously treated
- Life expectancy of less than 12 months
- Other skin lesions which may compromise the ability to complete this study, such as co-existing or adjacent melanoma or non-melanoma skin cancer. Co-existing adjacent actinic keratoses would not exclude the patient from the study
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 |
|---|---|---|
| ImiquimodAlso: Aldara 5% cream250mg sachets to be applied at a start dose of 5 days a week. Dose will be adjusted using an algorithm according to tolerability. | Drug | – |
Primary outcome
Pathological complete regression (PCR) in the mapped biopsied and resected LM using 2 mm slices.
Time frame: Results available at 1-2 week post surgery follow up visit.
5 secondary outcomes
Clinical assessment of response after imiquimod treatment
Time frame: Assessed at 12 week treatment visit and 1-2 week post surgery follow up
Clinical feasibility of imiquimod treatment
Time frame: Tolerability will be assessed during treatment period of 12 weeks
Number of consultations with NHS staff during imiquimod treatment
Time frame: Assessed up to week 12 visit
Frequency of functional T cell responses recognising peptide epitopes in melanocyte differentiation and cancer-testis antigens.
Time frame: Assessed with baseline and 12 week visit samples.
Measurement of hypothetical treatment preferences for surgery or imiquimod for LM using standard gamble technique.
Time frame: Questionnaire completed at 12 weeks post surgery (follow up visit)
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 20 Jun 2012.
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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.
Jerry Marsden, Dr principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imiquimod in people with Lentigo Maligna, run by Jerry Marsden at 1 site in United Kingdom.
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 5 inclusion and 10 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 20 Jun 2012. 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 United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Pathological complete regression (PCR) in the mapped biopsied and resected LM using 2 mm slices. (time frame: Results available at 1-2 week post surgery follow up visit.). It is what the study was designed to measure, not a finding.
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 20 Jun 2012.