Evaluation of a Topical Treatment for Actinic Keratosis

Phase 2 Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis of Face and Scalp
• Intervention / Treatment: Drug: Placebo; Drug: AD17137 topical treatment

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 6495301
    • Maccabi Health Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; topical treatment	Drug: AD17137 topical treatment
Placebo Comparator: Placebo; topical treatment	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Assuta Hospital Systems

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: August 12, 2013
• First Posted (Estimate): August 14, 2013

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: treatment; dermatology; topical; clinical study; Actinic keratosis; double blinded
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: AD17137