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Efficacy of Actixicam, a sunscreen with piroxicam, in actinic keratosis

Completed
Conditions
Actinic Keratosis
Skin and Connective Tissue Diseases
Registration Number
ISRCTN72020277
Lead Sponsor
Difa Cooper SpA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
60
Inclusion Criteria

1. At least 3 or more actinic keratosis lesions in a 35 cm2 area
2. Age >18 years
3. Fitzpatrick Phototype <III

Exclusion Criteria

1. Previous treatments for Actinic Keratosis
2. Presence of Non melanoma skin cancer
3. HIV infection or other immunodepression diseases
4. Allergy to piroxicam
5. Pregnancy or breastfeeding

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Total lesion number of Actinic Keratosis is assessed with a clinical count at baseline and 3 months<br>2. Dermatoscopy score of target lesion evolution (scoring erythema, scaling, pigmentation, follicular plug) at baseline and 3 months
Secondary Outcome Measures
NameTimeMethod
1. Severity index of AK lesions is assessed through clinical evaluation by the investigator at baseline and 3 months<br>2. Investigator Global Index is assessed through clinical evaluation by the investigator at baseline and 3 months
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