Clinical trial NCT01921907: Evaluation of a Topical Treatment for Actinic Keratosis
Official title: Phase 2 Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis of Face and Scalp
Keywords: Actinic keratosis
topical
dermatology
treatment
clinical study
double blinded
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: baseline to Week 7
Secondary outcomes:
measure: Partial Clearance (75% of AK lesions) from baseline (Visit 1) to Visits 3 and 4.
timeFrame: baseline to Week 7
measure: Mean change in lesion size
timeFrame: baseline to Week 7
measure: Change in Investigator Global Assessment
timeFrame: baseline to Week 7
measure: Mean change in lesion number
timeFrame: baseline to Week 7
measure: Change in Patient Global Assessment
timeFrame: baseline to Week 7
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Maccabi Health Clinic
Study officials:
References: