Actinic KeratosesPhase 3NCT01532453
Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients
A Phase 3 study testing MD-3511356 and Standard Sun Protection Measures in people with Actinic Keratoses and Squamous Cell Carcinomas, run by Spirig Pharma Ltd. at 10 sites in 9 countries.
Trial summary
The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Actinic Keratoses, Squamous Cell Carcinomas
- What is being tested?
- MD-3511356 and Standard Sun Protection Measures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 10 sitesin 9 countries
- Study dates
- Nov 2010to Jan 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-Patients of either sex aged ≥ 40 years
- Life-expectancy of 2 years at minimum
- Solid organ-transplant recipients who received a kidney (including pancreas), liver, lung, or heart transplant
- Patients treated for 5 years with an immunosuppressant medication
- Severe sun damage of the skin
- Multiple actinic keratoses (2-5 lesions) and/or multiple dysplastic naevi
- No present squamous cell carcinoma, basal cell carcinoma or malignant melanoma; but history of cutaneous/cutaneous invasive malignancy with restitutio ad integrum is allowed
- Patients who are able to understand and provide written informed consent to participate in the clinical trial (signed informed consent) according to ICH GCP
Who cannot join
- Non-Caucasian
- Absence of sun damage i.e. no signs of AK
- Multi-organ transplantation (exception: simultaneous transplantation of kidney and pancreas)
- Evidence of systemic infection, except viral hepatitis, at the time of recruitment
- Known or supposed systemic malignant tumour or systemic chemotherapy within the last 5 years prior to randomisation
- Patients participating in a clinical trial within the last four weeks before trial
Show all 11Show fewer
- Patients treated with the antitumour/antiangiogenetic immunosuppressant sirolimus, respectively everolimus, or acitretin or any other systemic treatment for AK at the time of randomisation
- Patients treated with a topical drug for the AK at the time of randomisation (exception: excision or Cryotherapy for hyperkeratotic lesions are allowed)
- Change of the immunosuppression-treatment less than 3 months ago or planned
- Present or planned interferon therapy (in liver transplant patients with hepatitis B/C)
- Female patients with childbearing potential with a positive pregnancy test, breast feeding, or female patients with childbearing potential without adequate contraception
Trial locations and contacts
10 sites in 9 countries.
10 sites in 9 countries
Germany2 sites
Klinikum der Charité Universitätsmedizin
Berlin, 10117
Hautklinik am Nationalen Zentrum für Tumorerkrankungen
Heidelberg
Switzerland1 site
Universitätsspital Zürich, Dermatologische Klinik
Zurich
About this study
Official title: Open, Multicentre, Randomised, Comparative, Prospective Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Solid Organ Transplanted Patients for Prevention of UV-induced Carcinogenic Skin Alterations
The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.
Read the detailed description
This open-label multicenter, randomized, inter-individual comparative, prospective clinical trial was designed to evaluate the efficacy and safety of MD 3511356 sunscreen in preventing AK and SCC in post transplant immune-suppressed patients compared to standard of care.
The present multicenter trial is intended to contribute to the evidence that daily sun protection will have a prophylactic effect in this high risk population of chronically immune compromised patients.
- Conditions
- Actinic Keratoses, Squamous Cell Carcinomas
- Being tested
- MD-3511356, Standard Sun Protection Measures
- Medical subject headings
- Keratosis, Actinic, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD-3511356Device
Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
Standard Sun Protection MeasuresOther
Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
| Study group | Role | What they receive |
|---|---|---|
| Standard Sun Protection Measures | Active comparator | Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget). Receives: Other: Standard Sun Protection Measures |
| MD-3511356 | Experimental | Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g). Receives: Device: MD-3511356 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas
Measured: 2 Years
Secondary outcomes (1)
Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startNov 2010
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: For futility reasons and potential "loss of chance" for MD 3511356 group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosesStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spirig Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claas Ulrich, MD, Principal investigator, Klinikum der Charité Universitätsmedizin, Hauttumorzentrum Charité, D-10117 Berlin/Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532453
- Sponsor's protocol ID
- SP 488/2009
- Status last verified
- Dec 2015
- First submitted
- 9 Feb 2012
- Last updated
- 8 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multicentre, Randomised, Comparative, Prospective Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Solid Organ Transplanted Patients for Prevention of UV-induced Carcinogenic Skin Alterations
- ClinicalTrials.gov ID
- NCT01532453
- Acronym / sponsor ID
- SP 488/2009
- Conditions
- Actinic Keratoses, Squamous Cell Carcinomas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For futility reasons and potential "loss of chance" for MD 3511356 group
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Spirig Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Posted 8 Jan 2016
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 trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.
Detailed description
This open-label multicenter, randomized, inter-individual comparative, prospective clinical trial was designed to evaluate the efficacy and safety of MD 3511356 sunscreen in preventing AK and SCC in post transplant immune-suppressed patients compared to standard of care.
The present multicenter trial is intended to contribute to the evidence that daily sun protection will have a prophylactic effect in this high risk population of chronically immune compromised patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Sun Protection Measures | Active comparator | Other: Standard Sun Protection MeasuresDetailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget). |
| MD-3511356 | Experimental | Device: MD-3511356Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Out-Patients of either sex aged ≥ 40 years
- Life-expectancy of 2 years at minimum
- Solid organ-transplant recipients who received a kidney (including pancreas), liver, lung, or heart transplant
- Patients treated for 5 years with an immunosuppressant medication
- Severe sun damage of the skin
Key exclusion criteria (11 listed)
- Non-Caucasian
- Absence of sun damage i.e. no signs of AK
- Multi-organ transplantation (exception: simultaneous transplantation of kidney and pancreas)
- Evidence of systemic infection, except viral hepatitis, at the time of recruitment
- Known or supposed systemic malignant tumour or systemic chemotherapy within the last 5 years prior to randomisation
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 |
|---|---|---|
| MD-3511356Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun. | Device | MD-3511356 |
| Standard Sun Protection MeasuresSelf-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product. | Other | Standard Sun Protection Measures |
Primary outcome
Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas
Time frame: 2 Years
1 secondary outcome
Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Claas Ulrich, MD principal investigator
Klinikum der Charité Universitätsmedizin, Hauttumorzentrum Charité, D-10117 Berlin/Germany
10 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MD-3511356 and Standard Sun Protection Measures in people with Actinic Keratoses and Squamous Cell Carcinomas, run by Spirig Pharma Ltd. at 10 sites in 9 countries.
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 11 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: stopped early, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Austria, Czechia, France, Ireland and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas (time frame: 2 Years). 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 8 Jan 2016.