Evaluation of a Topical Treatment for Actinic Keratosis

Phase 2

Completed

• Conditions: Actinic Keratosis of Face and Scalp
• Interventions: Drug: Placebo; Drug: AD17137 topical treatment

• Registration Number: NCT01921907
• Lead Sponsor: Assuta Hospital Systems

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-14
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2015-02
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	topical treatment
Active	AD17137 topical treatment	topical treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Mean change in lesion number	baseline to Week 7
Change in Patient Global Assessment	baseline to Week 7
Change in Investigator Global Assessment	baseline to Week 7

Trial Locations

Locations (1)

Maccabi Health Clinic; 🇮🇱 Tel Aviv, Israel