Actinic KeratosisMIKADONCT04202445
TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients Satisfaction
An observational study of Actinic Keratosis, run by LEO Pharma.
Trial summary
This is an observational longitudinal study, prospective, multicenter, performed in metropolitan France, on a representative sample of dermatologists. Data will be collected by physicians during 2 or 3 visits (according to their usual practice), from the patient file, questioning and clinical examination performed… 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?
- Ingenol mebutate
- How many people
- 1,218 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Feb 2016
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with actinic keratosis planned to receive treatment with ingenol mebutate at the discretion of the dermatologist
Who may be able to join
- Patient at least 18 years old, seen by the dermatologist during a consultation, whether actinic keratosis is the reason for consultation or not.
- Patient with AK lesions and for whom the dermatologist decided to initiate a treatment with Picato®* 150 or Picato®* 500
- Patient informed and accepting the automatic processing of medical data * To respect the physicians' independence, this study is conducted among patients for whom the decision of therapeutic care is not related to their inclusion.
Who cannot join
- Patient with a contraindication to treatment with Picato®.
- Patient unable to read and/or to understand a self-administered questionnaire.
- Patient already included in the study.
- Patient participating or having participated in the previous month in a clinical trial in dermatology.
About this study
This is an observational longitudinal study, prospective, multicenter, performed in metropolitan France, on a representative sample of dermatologists.
Data will be collected by physicians during 2 or 3 visits (according to their usual practice), from the patient file, questioning and clinical examination performed during these visits.
Data about the patient's perception (satisfaction, perception of local skin reactions, quality of life) will be collected directly by the patient using self-administered questionnaires at inclusion visit, day 7 and 2 months later.
Read the detailed description
Actinic keratosis (AKs) are common skin diseases affecting areas previously overexposed to the sun (in particular face, nape of the neck, hands). They affect mainly elderly people (mean age: 74 years old, with 97% who are over 50 years old) and preferably men (60%). In Europe, prevalence of AK in the adult population over 40 years is estimated to be between 6% and 25%.
Subjects at risk are light-skinned people (phototype I and II according to Fitzpatrick scale) with high cumulative sun exposure or phototherapy. Over 80% of patients have a light phototype and 37% of patients with AK have an outside professional activity.
Diagnosis of AK is usually clinical, during skin examination which is recommended for any physician's visit. There are often multiple lesions, some of which, in the absence of effective treatment, can progress to squamous cell carcinoma (0.025% to 20% per year/lesion).
Although the evolution rate of AKs to carcinoma remains low and disappearance or sole persistence of the lesion is possible, their evolution is unpredictable, and it is therefore recommended to monitor and treat the AKs.
Treatment options include cryotherapy, topical treatments, photodynamic therapy, vaporization of lesions by CO2 laser or electrocoagulation and curretage.
When there are few AK lesions, which are localized and with superficial forms, cryotherapy is the reference treatment (it is widely used by dermatologists, as it is simple, fast and does not require special equipment), whereas topical treatment (5-FU, imiquimod, diclofenac) is recommended in case of multiple keratosis or lesions on a larger area of the skin. The disadvantage of cryotherapy and photodynamic therapy is that these techniques can be painful and lead to depigmentation or scarring. Topical treatments which are available (imiquimod, 5-FU, diclofenac) may induce severe inflammatory reactions sometimes responsible for premature termination and thus ineffective.
Combined with their length (4 to 16 weeks), the complexity of current topical regimens would be the cause of poor compliance.
So, all dermatologists agree with the need to shorten duration of treatment and reduce the number of applications. Ingenol mebutate gel (Picato®), used in very short 2-3 days cycle, with one application per day, meets this need.
Development of ingenol mebutate gel included 4 pivotal phase III trials, evaluating its efficacy and safety. The results of these studies have established satisfactory efficacy and safety for Picato® with, on one hand, proven efficacy after two months for face, scalp, trunk and extremities and, on the other hand, transient local skin reactions (erythema, flaking/scaling, crusting,swelling,...), which appear early, peak in intensity after the end of treatment (day 3 or day 4) and disappear without sequelae within 2-4 weeks after application of the gel. At day 57, mean patient global satisfaction scores, either assessed with TSQM or Skindex-16, were statistically higher in the ingenol mebutate gel group than in the vehicle group. In a long term follow up study, ingenol mebutate produced clinically relevant sustained clearance and long-term lesion reduction.
These characteristics are a potentially important advantage for treatment compliance as well as for patient comfort.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol mebutate
- Keywords
- Actinic keratosis, Field treatment, Ingenol mebutate, Picato, Mikado
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingenol mebutateDrug
Also called Picato
Topical field treatment as prescribed by dermatologist
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction Questionnaire of Medication (TSQM-9)
The TSQM-9 scale is a 7-item instrument to be completed by patients. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domaine.
Measured: 2 months after end of treatment
Secondary outcomes (2)
Dermatology Life Quality Index - DLQI
Dermatology Life Quality Index is an index based on a series of 10 questions, each scored on a verbal rating scale with 2 to 4 answer categories, and except for three questions the option to state that the question is not relevant. The DLQI score is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Measured: Baseline and 2 months after end of treatment
Real-life efficacy of Picato
Efficacy assessed using the following scale filled out by the physician:
- How do you assess the treatment efficacy : 1-Excellent / 2-Good / 3-Mild / 4-Bad / 5-NA
Measured: Between Day 1 after the treatment application and 12 months (maximum 2 follow-up visits after the inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study startApr 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,218 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Moumane, MD, Study chair, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202445
- Sponsor's protocol ID
- NIS-PICATO-1087
- Acronym
- MIKADO
- Status last verified
- Dec 2019
- First submitted
- 15 Sep 2015
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Frost CA, Green AC. Epidemiology of solar keratoses. Br J Dermatol. 1994 Oct;131(4):455-64. doi: 10.1111/j.1365-2133.1994.tb08544.x.
PubMed 7947197Memon AA, Tomenson JA, Bothwell J, Friedmann PS. Prevalence of solar damage and actinic keratosis in a Merseyside population. Br J Dermatol. 2000 Jun;142(6):1154-9. doi: 10.1046/j.1365-2133.2000.03541.x.
PubMed 10848739Quaedvlieg PJ, Tirsi E, Thissen MR, Krekels GA. Actinic keratosis: how to differentiate the good from the bad ones? Eur J Dermatol. 2006 Jul-Aug;16(4):335-9.
PubMed 16935787Dinehart SM. The treatment of actinic keratoses. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):25-8. doi: 10.1067/mjd.2000.103338.
PubMed 10607354French Society of Dermatology. [Guidelines for the diagnosis and treatment of cutaneous squamous cell carcinoma and precursor lesions. Arguments - May 2009]. Ann Dermatol Venereol. 2009 Sep;136 Suppl 5:S189-242. No abstract available. French.
PubMed 19795558Thai KE, Fergin P, Freeman M, Vinciullo C, Francis D, Spelman L, Murrell D, Anderson C, Weightman W, Reid C, Watson A, Foley P. A prospective study of the use of cryosurgery for the treatment of actinic keratoses. Int J Dermatol. 2004 Sep;43(9):687-92. doi: 10.1111/j.1365-4632.2004.02056.x.
PubMed 15357755Burge SM, Bristol M, Millard PR, Dawber RP. Pigment changes in human skin after cryotherapy. Cryobiology. 1986 Oct;23(5):422-32. doi: 10.1016/0011-2240(86)90027-1.
PubMed 3769517Zouboulis CC. Cryosurgery in dermatology. Eur J Dermatol. 1998 Oct-Nov;8(7):466-74.
PubMed 9854156Fu W, Cockerell CJ. The actinic (solar) keratosis: a 21st-century perspective. Arch Dermatol. 2003 Jan;139(1):66-70. doi: 10.1001/archderm.139.1.66. No abstract available.
PubMed 12533168Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.
PubMed 22417254Anderson L, Schmieder GJ, Werschler WP, Tschen EH, Ling MR, Stough DB, Katsamas J. Randomized, double-blind, double-dummy, vehicle-controlled study of ingenol mebutate gel 0.025% and 0.05% for actinic keratosis. J Am Acad Dermatol. 2009 Jun;60(6):934-43. doi: 10.1016/j.jaad.2009.01.008.
PubMed 19467365Berman B. New developments in the treatment of actinic keratosis: focus on ingenol mebutate gel. Clin Cosmet Investig Dermatol. 2012;5:111-22. doi: 10.2147/CCID.S28905. Epub 2012 Aug 24.
PubMed 22956883
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients Satisfaction
- ClinicalTrials.gov ID
- NCT04202445
- Acronym / sponsor ID
- MIKADO / NIS-PICATO-1087
- Conditions
- Actinic Keratosis
- Keywords
- Actinic keratosis, Field treatment, Ingenol mebutate, Picato, Mikado
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,218 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Dec 2019 (actual)
- 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.
This is an observational longitudinal study, prospective, multicenter, performed in metropolitan France, on a representative sample of dermatologists.
Data will be collected by physicians during 2 or 3 visits (according to their usual practice), from the patient file, questioning and clinical examination performed during these visits.
Data about the patient's perception (satisfaction, perception of local skin reactions, quality of life) will be collected directly by the patient using self-administered questionnaires at inclusion visit, day 7 and 2 months later.
Detailed description
Actinic keratosis (AKs) are common skin diseases affecting areas previously overexposed to the sun (in particular face, nape of the neck, hands). They affect mainly elderly people (mean age: 74 years old, with 97% who are over 50 years old) and preferably men (60%). In Europe, prevalence of AK in the adult population over 40 years is estimated to be between 6% and 25%.
Subjects at risk are light-skinned people (phototype I and II according to Fitzpatrick scale) with high cumulative sun exposure or phototherapy. Over 80% of patients have a light phototype and 37% of patients with AK have an outside professional activity.
Diagnosis of AK is usually clinical, during skin examination which is recommended for any physician's visit. There are often multiple lesions, some of which, in the absence of effective treatment, can progress to squamous cell carcinoma (0.025% to 20% per year/lesion).
Although the evolution rate of AKs to carcinoma remains low and disappearance or sole persistence of the lesion is possible, their evolution is unpredictable, and it is therefore recommended to monitor and treat the AKs.
Treatment options include cryotherapy, topical treatments, photodynamic therapy, vaporization of lesions by CO2 laser or electrocoagulation and curretage.
When there are few AK lesions, which are localized and with superficial forms, cryotherapy is the reference treatment (it is widely used by dermatologists, as it is simple, fast and does not require special equipment), whereas topical treatment (5-FU, imiquimod, diclofenac) is recommended in case of multiple keratosis or lesions on a larger area of the skin. The disadvantage of cryotherapy and photodynamic therapy is that these techniques can be painful and lead to depigmentation or scarring. Topical treatments which are available (imiquimod, 5-FU, diclofenac) may induce severe inflammatory reactions sometimes responsible for premature termination and thus ineffective.
Combined with their length (4 to 16 weeks), the complexity of current topical regimens would be the cause of poor compliance.
So, all dermatologists agree with the need to shorten duration of treatment and reduce the number of applications. Ingenol mebutate gel (Picato®), used in very short 2-3 days cycle, with one application per day, meets this need.
Development of ingenol mebutate gel included 4 pivotal phase III trials, evaluating its efficacy and safety. The results of these studies have established satisfactory efficacy and safety for Picato® with, on one hand, proven efficacy after two months for face, scalp, trunk and extremities and, on the other hand, transient local skin reactions (erythema, flaking/scaling, crusting,swelling,...), which appear early, peak in intensity after the end of treatment (day 3 or day 4) and disappear without sequelae within 2-4 weeks after application of the gel. At day 57, mean patient global satisfaction scores, either assessed with TSQM or Skindex-16, were statistically higher in the ingenol mebutate gel group than in the vehicle group. In a long term follow up study, ingenol mebutate produced clinically relevant sustained clearance and long-term lesion reduction.
These characteristics are a potentially important advantage for treatment compliance as well as for patient comfort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with actinic keratosis planned to receive treatment with ingenol mebutate at the discretion of the dermatologist
Key inclusion criteria (3 listed)
- Patient at least 18 years old, seen by the dermatologist during a consultation, whether actinic keratosis is the reason for consultation or not.
- Patient with AK lesions and for whom the dermatologist decided to initiate a treatment with Picato®* 150 or Picato®* 500
- Patient informed and accepting the automatic processing of medical data * To respect the physicians' independence, this study is conducted among patients for whom the decision of therapeutic care is not related to their inclusion.
Key exclusion criteria (4 listed)
- Patient with a contraindication to treatment with Picato®.
- Patient unable to read and/or to understand a self-administered questionnaire.
- Patient already included in the study.
- Patient participating or having participated in the previous month in a clinical trial in dermatology.
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 |
|---|---|---|
| Ingenol mebutateAlso: PicatoTopical field treatment as prescribed by dermatologist | Drug | – |
Primary outcome
Treatment Satisfaction Questionnaire of Medication (TSQM-9)
Time frame: 2 months after end of treatment
The TSQM-9 scale is a 7-item instrument to be completed by patients. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domaine.
2 secondary outcomes
Dermatology Life Quality Index - DLQI
Time frame: Baseline and 2 months after end of treatment
Real-life efficacy of Picato
Time frame: Between Day 1 after the treatment application and 12 months (maximum 2 follow-up visits after the inclusion)
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 9 Jun 2023.
- Background: PubMed 7947197Frost CA, Green AC. Epidemiology of solar keratoses. Br J Dermatol. 1994 Oct;131(4):455-64. doi: 10.1111/j.1365-2133.1994.tb08544.x.
- Background: PubMed 10848739Memon AA, Tomenson JA, Bothwell J, Friedmann PS. Prevalence of solar damage and actinic keratosis in a Merseyside population. Br J Dermatol. 2000 Jun;142(6):1154-9. doi: 10.1046/j.1365-2133.2000.03541.x.
- Background: PubMed 16935787Quaedvlieg PJ, Tirsi E, Thissen MR, Krekels GA. Actinic keratosis: how to differentiate the good from the bad ones? Eur J Dermatol. 2006 Jul-Aug;16(4):335-9.
- Background: PubMed 10607354Dinehart SM. The treatment of actinic keratoses. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):25-8. doi: 10.1067/mjd.2000.103338.
- Background: PubMed 19795558French Society of Dermatology. [Guidelines for the diagnosis and treatment of cutaneous squamous cell carcinoma and precursor lesions. Arguments - May 2009]. Ann Dermatol Venereol. 2009 Sep;136 Suppl 5:S189-242. No abstract available. French.
- Background: PubMed 15357755Thai KE, Fergin P, Freeman M, Vinciullo C, Francis D, Spelman L, Murrell D, Anderson C, Weightman W, Reid C, Watson A, Foley P. A prospective study of the use of cryosurgery for the treatment of actinic keratoses. Int J Dermatol. 2004 Sep;43(9):687-92. doi: 10.1111/j.1365-4632.2004.02056.x.
- Background: PubMed 3769517Burge SM, Bristol M, Millard PR, Dawber RP. Pigment changes in human skin after cryotherapy. Cryobiology. 1986 Oct;23(5):422-32. doi: 10.1016/0011-2240(86)90027-1.
- Background: PubMed 9854156Zouboulis CC. Cryosurgery in dermatology. Eur J Dermatol. 1998 Oct-Nov;8(7):466-74.
- Background: PubMed 12533168Fu W, Cockerell CJ. The actinic (solar) keratosis: a 21st-century perspective. Arch Dermatol. 2003 Jan;139(1):66-70. doi: 10.1001/archderm.139.1.66. No abstract available.
- Background: PubMed 22417254Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.
- Background: PubMed 19467365Anderson L, Schmieder GJ, Werschler WP, Tschen EH, Ling MR, Stough DB, Katsamas J. Randomized, double-blind, double-dummy, vehicle-controlled study of ingenol mebutate gel 0.025% and 0.05% for actinic keratosis. J Am Acad Dermatol. 2009 Jun;60(6):934-43. doi: 10.1016/j.jaad.2009.01.008.
- Background: PubMed 22956883Berman B. New developments in the treatment of actinic keratosis: focus on ingenol mebutate gel. Clin Cosmet Investig Dermatol. 2012;5:111-22. doi: 10.2147/CCID.S28905. Epub 2012 Aug 24.
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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.
Sarah Moumane, MD study chair
LEO Pharma
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratosis, run by LEO Pharma.
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 3 inclusion and 4 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Treatment Satisfaction Questionnaire of Medication (TSQM-9) (time frame: 2 months after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04202445, which also lists 12 linked publications.
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 9 Jun 2023.