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

Efficacy of a medical device containing sunscreen and piroxicam in the treatment of actinic keratosis: a multicenter assessor-blinded trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72020277

Enrollment

Registered

2016-12-23

Start date

2016-06-15

Completion date

Unknown

Last updated

2017-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis Skin and Connective Tissue Diseases Actinic Keratosis

Interventions

All participants are aasked to apply the investigational drug (a cream) which contains chemical and physical sunscreen (SPF 50+) and piroxicam 0.8%, twice daily (morning and evening) to face and scalp

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Secondary

Measure	Time frame
1. Severity index of AK lesions is assessed through clinical evaluation by the investigator at baseline and 3 months 2. Investigator Global Index is assessed through clinical evaluation by the investigator at baseline and 3 months	—

Primary

Measure	Time frame
1. Total lesion number of Actinic Keratosis is assessed with a clinical count at baseline and 3 months 2. Dermatoscopy score of target lesion evolution (scoring erythema, scaling, pigmentation, follicular plug) at baseline and 3 months	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026