Multiple Actinic Keratosis MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: SOLARAZE - "3% GEL" 1 TUBO DA 60 G GEL
Product Name: SOLARAZE
Product Code: [ND]
Pharmaceutical Form: Gel
INN or Proposed INN: DICLOFENAC SODICO
Current Sponsor code: ND
Concentration unit
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with clinically typical, visible and discrete multiple AK, grade I/II according to Olsen’s classification, in a skin area of 50 cm2, for whom the treating dermatologist has prescribed diclofenac in hyaluronic acid gel 3% (Solaraze 3%). Those patients should have not started the treatment before the inclusion in the present study . 2. Willing to participate in the study and able to provide informed consent. 3. Age = 18 years 4. Able to read and write in Italian Language 5. Women with childbearing potential willing not to start a pregnancy during the course f the study and for 1 month after the conclusion of the treatment 6. Men having relationships with women with childbearing potential willing not to procure a pregnancy during the course of the study and for 1 month after the conclusion of the treatment. 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 91 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 91
Exclusion criteria
Exclusion criteria: 1. Unable to understand and execute simple instructions or patients in need of assistance from a caregiver (professional or non-professional) for the application of topical medication. 2. Patients immunocompromised as per medical history (i.e. iatrogenic immunosuppression, HIV / AIDS) 3. Any major surgery or major clinical events (i.e. ictus cerebri, myocardial infarction, etc) in the month prior to screening (may affect Patient-Reported Outcomes) 4. Previous treatments with field-directed therapy in the past 3 months before the screening. 5. Aspirin-sensitive patients, due to possible cross-reactivity with diclofenac in hyaluronic acid gel 3% (Solaraze %). 6. Pregnant and breast-feeding women 7. Forecast of moving to another region within the next 12 months following the potential inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy of an integrated low-intensity intervention program against standard-of-care on treatment adherence among patients with multiple AK receiving diclofenac in hyaluronic acid gel 3% (Solaraze 3%). ;Secondary Objective: to evaluate the efficacy of an integrated low-intensity intervention program against standard-of-care on: - Patient’s complete and partial Lesion Clearance Rate at the end of treatment (3-months); - Patient’s complete and partial Sustained Lesion Clearance Rate (at 6- and 12- month); - Patient’s Complete Lesion Clearance Rate (at 3-, 6- and 12-month). - Treatment Satisfaction at the end of treatment (at 3-month); - Impact of AK on Quality of Life (at 3-month); - Local Skin Reaction (LSR) score (3-month); - Direct Cost of Intervention (at 3-month); - To create the content and editing of the educational material and the phone reminder (before RCT starts) ;Primary end point(s): To define the Adherence to the treatment regimen as product use greater than 80% of prescribed dose, and will be calculated according to the Formula: A= [(Wb-We)/Wnb] x 100, where Wb is the gross weight at baseline, We is the gross weight at the end of self-administration, Wnb is the product net nominal weight at baseline. ;Timepoint(s) of evaluation of this end point: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. 3-months Lesion Clearance Rate: the rate of lesion clearance will be defined as the ratio between the number of residual AK lesion count and baseline AK count in the treated area 2. 6-months and 12-months Sustained Lesion Clearance Rate: the rate of sustained lesion clearance will be defined as the ratio between the number of residual AK lesion count at each time point and baseline AK count in the treated area. 3. Patient’s Complete Clearance Rate at 3, 6 and 12 months: patient’s complete clearance is defined as clearance of all AK lesions identified at baseline. 4. Patient’s Partial Clearance Rate at 3, 6 and 12 months: patient’s partial clearance is defined as clearance of 75% of AK lesions identified at baseline. 5. Treatment Satisfaction on Medication (3 items) (included in the AK QoL) 6. Quality of Life: AK-QOL questionnaire; 7. Local Skin Reaction; LSR score will be evaluated with a 6 items scale (Lebowhol et al., 2012). 8. Intervention Costs per patient. Direct cost will be considered the cost of all medical encounters including extra-visits and phone consultations, health education brochure, sms reminders, product wastage (weight of unused product). The cost incurred for study outcome evaluation (i.e. evaluation of LSR, tube weighting, assessment of lesion clearance) will not be included. Medical encounters will be defined as very short (t20’). At the end of each interaction, the attending physicians will record the approximate duration of each visit at first in the ad hoc form and then in the eCRF. 9. The content and editing of the educational material used for the RCT. ;Timepoint(s) of evaluation of this end point: 12 MONTHS | — |
Countries
Italy
Contacts
Public ContactUnità CRO
Clinical Trial Center SPA
Outcome results
None listed