Evaluation of a Topical Treatment for Actinic Keratosis

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study

Conditions
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Actinic Keratosis of Face and Scalp

Intervention / Treatment
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* Drug: AD17137 topical treatment
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>topical treatment | Drug: AD17137 topical treatment<br> <br> |
| Placebo Comparator: Placebo<br>topical treatment | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 |  | baseline to Week 7 | 
| Mean change in lesion number |  | baseline to Week 7 | 
| Change in Patient Global Assessment |  | baseline to Week 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic keratosis, topical, dermatology, treatment, clinical study, double blinded