actinic keratosis MedDRA version: 16.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: ZYCLARA 3,75% crema
Product Name: zyclara
Pharmaceutical Form: Cream
INN or Proposed INN: IMIQUIMOD
CAS Number: 99011-02-6
Concentration unit: % (V/V) percent volume/volume
Concentration t
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Immunocompetent Caucasian patient. 2. 5-20 clinically evident AK lesions either on full face or balding scalp. 3. Male or female without child-bearing potential. 4. Having at least 1 AK and 1 subclinical lesion in the study area diagnosed by HD-OCT or RCM. 5. Willingness to have reflectance confocal microscopy examination and HD-OCT examination performed in treatment area 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 1 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1. Contraindications for imiquimod treatment: Hypersensitivity to imiquimod or to any of the excipients (isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum). 2. Broken skin in the study treatment area. 3. Autoimmune condition. 4. Severe haematological disease 5. Presence of AK lesions in the STA with clinically excessive hyperkeratosis as seen in cutaneous horns. 6. Treatment of AKs in region of eyes, lips or nostrils 7. Any kind of AK treatment at the STA within the last 2 months prior to patient inclusion. 8. Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen?s disease, invasive SCC, basal cell carcinoma, or other malignant tumours. 9. Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment. 10. History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years which might hinder regular treatment and supervision and might lead to premature withdrawal from the study. 11. Mentally incapacitated patient. 12. Present or history of drug or alcohol abuse within the last 3 years. 13. Exposure to an investigational product within the last 3 months. 14. Lack of ability or willingness to give informed consent. 15. Age below 18 years. 16. Lack of willingness to have personal study related data collected, archived or transmitted according to protocol. 17. Anticipated non-availability for study visits/procedures. 18. Vulnerable subjects (such as persons kept in detention) 19. The planned sample size has been reached.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 5in vivo comparison of effect of imiquimod 3.75% in detection of subclinical lesions of actinic keratosis using high definition optical coherence tomography (HD-OCT) and Reflectance confocal microscopy (RCM).;Secondary Objective: clinical classification os all lesion observed clinical evaluation of actinic keratosis adverse events;Primary end point(s): Number of subclinical lesions previously determined (at W0) by non invasive methods by RCM and /or HD-OCT that become clinically visible and clear during treatment with IMIQ 3.75% at week 14.;Timepoint(s) of evaluation of this end point: week 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): b) Clinical classification in all areas at any visit of the predefined diagnostic areas for type of AK lesions. The study area will be evaluated for the presence and number of: 1. Non-affected; 2. Subclinical AK; 3. Clinical visible AK. (schematics with a grid will be used to asses the presence and localisation of AK , new AK, subclinical AK and inflammation on clinical naked-eye examination ). c) OCT/RCM evaluation of clinically apparent AK at W6 and W14 and additionally at W2 and W4 on decision of investigator (for inflammatory reactions) d) Number of countable new AK lesions at every evaluation up to Week 14 e) Number of subclinical lesions turning visible under therapy and cleared at W14. f) Adverse events in the study treatment area and in predefined diagnostic areas.;Timepoint(s) of evaluation of this end point: weeks 2,4,6 and 14 | — |
Countries
Spain
Contacts
Public ContactDERMATOLOGY DEPARTMENT
HOSPITAL CLINIC BARCELONA
Outcome results
None listed