patients with actinic keratoses (AK)
Conditions
Interventions
Product Name: Fenaraze®/HELP
Pharmaceutical Form: Gel
INN or Proposed INN: DICLOFENAC SODIUM
CAS Number: 15307796
Concentration unit: % percent
Concentration type: equal
Concentration number: 3-
Pharm
Sponsors
HELP Pharmaceuticals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are able to read and comprehend the informed consent form 2. Patients who have signed the informed consent form 3. Patients with visible and histologically (> 20% of patients) proven actinic keratosis, who have a clinical diagnosis of AKs in at least one of the selected major body areas (forehead, central face, scalp, dorsa of hands) 4. External (ambulatory) patients, of both sexes, of ages between 35 and 75 inclusively 5. Patients who, in the investigator’s opinion, are otherwise healthy based on physical examination, medical history, and vital signs 6. Patients who are willing and able to attend study appointments within allowed time limits 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have participated earlier (< 1 month) in another clinical trial 2- Patients who are taking prohibited recent or synchronious pharmaceutical prescription, meaning: imiquimod or 5-FU, etretinate, cyclosporine, retinoids, topical steroids or recent trichloroacetic acid or glycolic acid peels) in the time span of last one month before the start of the trial. 3- Patients with clinically significant, unstable, cardiovascular or haematologic, hepatic, neurologic, renal endocrine or gastrointestinal abnormalities or diseases. 4- Any dermatological disease and/or condition in the treatment or surrounding area (3cm distances from treatment area) that may be exacerbated by treatment with diclofenac or cause difficulty with examination. 5. Patients with lesions on the lips 6 Female patients who are pregnant or are lactating. 7.Female patients with the ability to procreate and who are not using adequate contraception 8.Patients with known allergies to any excipient in the study drug 9. Patients who have a known sensitivity reaction like asthma, pruritus or allergic rhinitis following treatment with acetylsalicylic acid or other nonsteroidal anti-inflammatoty drugs (NSAIDs). 10. Patients who, in the investigator’s opinion, are unlikely to comply with the clinical study protocol , or who are not appropriate for any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the trial is to assess the efficacy of diclofenac sodium 3% administered topically in patients with actinic keratoses (AK).;Secondary Objective: Primary objective of the trial is to assess the safety of diclofenac sodium 3% administered topically in patients with actinic keratoses (AK).;Primary end point(s): •Change in the TLNS (Target Lesion Number Score). •Change in the CLNS (Cumulative Lesion Number Score). •Change in the IGII (Investigator Global Improvement Index). •Change in the PGII (Patient Global Improvement Index). | — |
Countries
Greece
Outcome results
None listed