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Evaluation of a Topical Treatment for Actinic Keratosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01921907
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : March 10, 2015
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
Study Start Date : July 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: Active
topical treatment
Drug: AD17137 topical treatment
Placebo Comparator: Placebo
topical treatment
Drug: Placebo

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01921907

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Maccabi Health Clinic
Tel Aviv, Israel, 6495301
Sponsors and Collaborators
Assuta Hospital Systems
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Responsible Party: Assuta Hospital Systems Identifier: NCT01921907    
Other Study ID Numbers: AD17137
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: February 2015
Keywords provided by Assuta Hospital Systems:
Actinic keratosis
clinical study
double blinded
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Diseases
Precancerous Conditions