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TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients Satisfaction (MIKADO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04202445
Recruitment Status : Completed
First Posted : December 17, 2019
Last Update Posted : December 20, 2019
Information provided by (Responsible Party):
LEO Pharma

Brief 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 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.

Condition or disease Intervention/treatment
Actinic Keratosis Drug: Ingenol mebutate

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.

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Study Type : Observational
Actual Enrollment : 1218 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients Satisfaction
Actual Study Start Date : April 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Ingenol mebutate
    Topical field treatment as prescribed by dermatologist
    Other Name: Picato

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Dermatology Life Quality Index - DLQI [ Time Frame: Baseline and 2 months after end of treatment ]
    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.

  2. 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) ]

    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients diagnosed with actinic keratosis planned to receive treatment with ingenol mebutate at the discretion of the dermatologist

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04202445

Sponsors and Collaborators
LEO Pharma
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Study Chair: Sarah Moumane, MD LEO Pharma

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Responsible Party: LEO Pharma Identifier: NCT04202445    
Other Study ID Numbers: NIS-PICATO-1087
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Keywords provided by LEO Pharma:
Actinic keratosis
Field treatment
Ingenol mebutate
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Diseases
Precancerous Conditions