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Evaluation of a Topical Treatment for Actinic Keratosis

Primary Purpose

Actinic Keratosis of Face and Scalp

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

AD17137 topical treatment

Placebo

About this trial

This is an interventional treatment trial for Actinic Keratosis of Face and Scalp focused on measuring Actinic keratosis, topical, dermatology, treatment, clinical study, double blinded

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Maccabi Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

topical treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Partial Clearance (75% of AK lesions) from baseline (Visit 1) to Visits 3 and 4.

Mean change in lesion size

Change in Investigator Global Assessment

Mean change in lesion number

Change in Patient Global Assessment

Full Information

NCT ID

NCT01921907

First Posted

July 31, 2013

Last Updated

March 9, 2015

Sponsor

Assuta Hospital Systems

1. Study Identification

Unique Protocol Identification Number

NCT01921907

Brief Title

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

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assuta Hospital Systems

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis of Face and Scalp

Keywords

Actinic keratosis, topical, dermatology, treatment, clinical study, double blinded

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

topical treatment

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

topical treatment

Intervention Type

Drug

Intervention Name(s)

AD17137 topical treatment

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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.

Time Frame

baseline to Week 7

Secondary Outcome Measure Information:

Title

Partial Clearance (75% of AK lesions) from baseline (Visit 1) to Visits 3 and 4.

Time Frame

baseline to Week 7

Title

Mean change in lesion size

Time Frame

baseline to Week 7

Title

Change in Investigator Global Assessment

Time Frame

baseline to Week 7

Title

Mean change in lesion number

Time Frame

baseline to Week 7

Title

Change in Patient Global Assessment

Time Frame

baseline to Week 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Maccabi Health Clinic

City

Tel Aviv

ZIP/Postal Code

6495301

Country

Israel

12. IPD Sharing Statement

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Evaluation of a Topical Treatment for Actinic Keratosis

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