Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head

Study Overview
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Brief Summary
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Topical treatment of mild to moderate actinic keratosis located on the face and head with Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an expansion of the treatment period to 6 months will increase the rate of complete responses. Therefore the investigators will evaluate the efficacy and safety of the treatment of actinic keratosis with Solaraze® applied twice daily to the face and head over 3 or 6 months of treatment.

Official Title
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Comparison of the Efficacy and Tolerability of Solaraze for 3 vs. 6 Months in Patients With Mild to Moderate Actinic Keratosis Located at the Face and Head

Conditions
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Photosensitivity Disorders

Intervention / Treatment
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* Drug: Diclofenac
* Drug: Diclofenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Visible and histologically proven actinic keratosis Prepared and able to give written informed consent ≥ 18 -80 years of age Prepared and comply with all study requirements, including the following: application of gel on the treatment area twice a day, 5 / 7 clinic visits during the prestudy, treatment, posttreatment, and follow-up period Pre- and posttreatment biopsy for histological confirmation (of clearance) of actinic keratosis diagnosis Exclusion Criteria: Data of clinically significant, unstable, cardiovascular or haematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases Known allergies to any excipient in the study drug Any dermatological disease and/or condition in the treatment or surrounding area (3 cm distances from treatment area) that may be exacerbated by treatment with diclofenac or cause difficulty with examination Active chemical dependency or alcoholism, as assessed by the investigator Currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 30 days Received topical treatment at the treatment area with imiquimod or 5-FU within a time period of 1 month Invasive tumours within the treatment area, e.g. merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Solaraze(R) 2x/day for 3 months | Drug: Diclofenac<br>* Solaraze® (Diclofenac sodium) 2x/day topical for 3 months<br>|
| Active Comparator: B<br>Solaraze(R) 2x/day for 6 months | Drug: Diclofenac<br>* Solaraze® (Diclofenac sodium) 2x/day topical for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologically controlled complete clearance of the actinic keratosis |  | 6 weeks after end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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actinic keratosis, diclofenac sodium