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Evaluation of a Topical Treatment for Actinic Keratosis

This study has been completed.
Information provided by (Responsible Party):
Assuta Hospital Systems Identifier:
First received: July 31, 2013
Last updated: March 9, 2015
Last verified: February 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:
  • Partial Clearance (75% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. [ Time Frame: baseline to Week 7 ]
  • Mean change in lesion size [ Time Frame: baseline to Week 7 ]
  • Change in Investigator Global Assessment [ Time Frame: baseline to Week 7 ]
  • Mean change in lesion number [ Time Frame: baseline to Week 7 ]
  • Change in Patient Global Assessment [ Time Frame: baseline to Week 7 ]

Enrollment: 52
Study Start Date: July 2013
Study Completion Date: July 2014
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


Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01921907

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

Responsible Party: Assuta Hospital Systems Identifier: NCT01921907     History of Changes
Other Study ID Numbers: AD17137
Study First Received: July 31, 2013
Last Updated: March 9, 2015

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

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms processed this record on June 23, 2017