Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of a Topical Treatment for Actinic Keratosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Assuta Hospital Systems
Sponsor:
Information provided by (Responsible Party):
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT01921907
First received: July 31, 2013
Last updated: August 12, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis of Face and Scalp
Drug: AD17137 topical treatment
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study

Resource links provided by NLM:


Further study details as provided by Assuta Hospital Systems:

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. [ Time Frame: baseline to Week 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Partial Clearance (75% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. [ Time Frame: baseline to Week 7 ] [ Designated as safety issue: No ]
  • Mean change in lesion size [ Time Frame: baseline to Week 7 ] [ Designated as safety issue: No ]
  • Change in Investigator Global Assessment [ Time Frame: baseline to Week 7 ] [ Designated as safety issue: No ]
  • Mean change in lesion number [ Time Frame: baseline to Week 7 ] [ Designated as safety issue: No ]
  • Change in Patient Global Assessment [ Time Frame: baseline to Week 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
topical treatment
Drug: AD17137 topical treatment
Placebo Comparator: Placebo
topical treatment
Drug: Placebo

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01921907

Contacts
Contact: Avi Dascalu, M.D., Ph.D. +97236099005 dasc01@yahoo.com

Locations
Israel
Maccabi Health Clinic Recruiting
Tel Aviv, Israel, 6495301
Sponsors and Collaborators
Assuta Hospital Systems
  More Information

No publications provided

Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT01921907     History of Changes
Other Study ID Numbers: AD17137
Study First Received: July 31, 2013
Last Updated: August 12, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Assuta Hospital Systems:
Actinic keratosis
topical
dermatology
treatment
clinical study
double blinded

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Neoplasms
Precancerous Conditions
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014