Actinic Keratoses MedDRA version: 14.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Picato®
Pharmaceutical Form: Gel
INN or Proposed INN: INGENOL MEBUTATE
Other descriptive name: INGENOL MEBUTATE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Sponsors
Department of Dermatology, Bispebjerg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18 or older • Two eligible areas of 25 cm2 containing 4-20 AK lesions in the face or two eligible areas of 25 cm2 containing 4-20 AK lesions in the scalp • Minimally four lesions in every area are Grade I or II (Grade I: Thin lesions, are better felt than seen, Grade II: Moderately thick, are easily seen and felt, Grade III Very thick and/or hyperkeratotik lesions) • Fertile women must document non-reactive urine pregnancy test at the day of inclusion • During the study fertile women must be using effective birth control. Effective contraception is defined as follows: o Injectable or implantable hormones; o Intrauterine device; o Trans-abdominal surgical sterilization; o Sterilization implant device; o Surgical sterilization of male partner; o Complete abstinence from sexual intercourse for two weeks before exposure to study medication and throughout the clinical study • Verbal and written consent to participate in the study • Documentation of the medicine status Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: • Non-melanoma skin cancer, Mb. Bowen or keratoacanthoma in the treatment area • Previously treated with Ingenol Mebutate in the treatment area • Tattoos, moles, or other active dermatological condition in the treatment area • History of Psoriasis • Medication with a systemic immunosuppressive, cytotoxic, immune modulating or retinoid agent within the last 3 months • Use of topical applicants in the treated area that could interfere with the treatment or evaluation of the treatment the first 14 days, including commercially available day and night crèmes with retinoid agents • Pregnant and breastfeeding women • Patients that are considered incapable of complying with the protocol, i.e. patients suffering from dementia, alcoholism or psychiatric conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to investigate whether local skin responses seen after Picato® can be treated with a topical glucocorticosteroid. Secondary objective is to investigate if the treatment efficacy is affected by it. It is the perspective of this study to be offer patients safe treatment of local skin responses after Picato® treatment while maintaining an effective eradication of the Actinic Keratoses.;Secondary Objective: Evaluate if patient satisfaction as well as short and long term side effects (hyperpigmentation, hypopigmentation and scarring) are affected by the use of a topical glucocorticosteroid after Picato® treatment.;Primary end point(s): Local skin reactions (LSR), clinical evaluation. Blinded clinical evaluation by a physician. The LSR Grading Scale is used to graduate Erythema 0-4, Flaking/Scaling 0-4, Crusting 0-4, Swelling 0-4, Vesiculation/Pustulation 0-4, Erosion/Ulceration 0-4. The scores are added for each patient, giving a maximum of 24 and a minimum of 0. ;Timepoint(s) of evaluation of this end point: At day 1, 4, 8, 15 and 57 after treatment with Picato® | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Defined in E.5.2;Secondary end point(s): 1. Efficacy, day 15 and 57. a. Number of cleared AK's b. Complete clearance of the AK's in the field c. Partial clearance, >75% reduction in number of the AK's in the field d. Median reduction in the number of cleared AK's in the field e. New AKs All efficacy measures will be clinically evaluated by a blinded Dermatologist. The initial template is used to evaluate clearance of every original lesion. If not cleared, the grade of the remaining lesion is registered. 2. Photographic documentation of LSR and treatment effect, day 1, 4, 8, 15 and 57. At baseline and follow-up visits, LSR and clinical treatment effects will be photographically documented. 3. Reflectance at day 1,4,8,15 and 57 (Optimizer) The Optimizer is used to evaluate reflectance including Pigment protection factor, Pigmentation, Erythema, Green reflection and red reflection. The measures are aimed at the background skin in the center area and repeated three times, the median value is used. 4. Delayed side effects at day 15 and 57. Blinded clinical evaluation by a dermatologist. All treatment areas will be evaluated for hypopigmentation (0-3), hyperpigmentation (0-3) and scarring (0-2). 5. Patient satisfaction at day 15 and 57. The treating physician will ask the patient which one of the two treatments that was most satisfactory. 6. Pain and prutitus day 1-15 The patient will be asked to daily score LSR, pain and prutitus associated with the treatments in a patient diary. LSR are evaluated as "worse", "unchanged" or "better" compared to the day before. Every day the patient is asked if LSR are back to baseline. Pain is evaluated using a visual analog scale 0-10 and pruritus, 1-4. | — |
Countries
Denmark
Contacts
Public ContactClinical Trail Information
Department of Dermatology, Bispebjerg University Hospital
Outcome results
None listed