Actinic Keratosis of Face and Scalp
Conditions
Keywords
Actinic keratosis, topical, dermatology, treatment, clinical study, double blinded
Brief summary
A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be treated by the active component.
Interventions
DRUGPlacebo
DRUGAD17137 topical treatment
Sponsors
Assuta Hospital Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Males or females 30 to 90 years old, inclusive, in good general health * Clinical diagnosis of Actinic Keratosis * At least 2 clinically diagnosed, 3-15 mm AK lesions on face or scalp * Patient is competent to understand and sign a consent form, and is willing and able to follow study procedures and attend all visits * Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication * Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception * Pharmacologic methods of contraception should be stable for 1 month prior to Visit 1 and be maintained at same dose during the study
Exclusion criteria
* Patients who had been treated with: 5-FU, diclofenac, retinoids, ingenol mebutate or imiquimod within 4 weeks of study, immunomodulators, or interferon/interferon inducers or systemic immunosuppressants within 8 weeks of study, cryodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks of study, systemic cancer therapy, UVA therapy, UVB therapy, laser abrasion, dermabrasion * History of hereditary angio-edema, Epilepsy or Parkinson's Disease * Erythroderma or history of immunodeficiency disorders * Pregnancy, lactation or patient who is not practicing effective contraception * History of alcohol and drug abuse within 5 years of screening * Known hypersensitivity or previous allergic reaction to any of the components of the study medication * Having a member of the same household in the trial * Patient has participated in an investigational clinical, surgical, drug or device study within the past 30 days * Patients who in the opinion of the investigator should not be included in the study for any reason, including inability to follow procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. | baseline to Week 7 |
Secondary
| Measure | Time frame |
|---|---|
| Partial Clearance (75% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. | baseline to Week 7 |
| Mean change in lesion size | baseline to Week 7 |
| Change in Investigator Global Assessment | baseline to Week 7 |
| Mean change in lesion number | baseline to Week 7 |
| Change in Patient Global Assessment | baseline to Week 7 |
Countries
Israel
Outcome results
None listed