Evaluation of a Topical Treatment for Actinic Keratosis | NCT01921907

Studies
Evaluation of a Topical Treatment for Actinic Keratosis

NCT01921907

Sponsor

Assuta Hospital Systems

Status

Completed

Last Update Posted

Mar 10, 2015Estimated

Enrollment

52Actual

Phase

Phase 2

Conditions

Actinic Keratosis of Face and Scalp

Interventions

AD17137 topical treatment
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jul 31, 2013

First Submission Date that Met QC Criteria

Aug 12, 2013

First Posted Date

Aug 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2015

Last Update Posted Date

Mar 10, 2015Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Label	Type	Description	Intervention Names
Active	Experimental	topical treatment	Drug: AD17137 topical treatment
Placebo	Placebo Comparator	topical treatment	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AD17137 topical treatment	Drug		Active
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D007642	Keratosis
D012871	Skin Diseases