Actinic Keratosis of Face and Scalp Clinical Trial
Official title:
Phase 2 Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
| Verified date | February 2015 |
| Source | Assuta Hospital Systems |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | July 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Maccabi Health Clinic | Tel Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| Assuta Hospital Systems |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | Partial Clearance (75% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. | baseline to Week 7 | No | |
| Secondary | Mean change in lesion size | baseline to Week 7 | No | |
| Secondary | Change in Investigator Global Assessment | baseline to Week 7 | No | |
| Secondary | Mean change in lesion number | baseline to Week 7 | No | |
| Secondary | Change in Patient Global Assessment | baseline to Week 7 | No |