Efficacy of a sunscreen containing the anti-iflammatory piroxicam in the treatment of early skin cancer

Effects of topical piroxicam and sun filters in actinic keratosis evolution and field cancerization: a two-center, assessor-blinded, clinical, confocal microscopy and dermoscopy evaluation trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN22070974

Enrollment

Registered

2019-04-30

Start date

2016-09-01

Completion date

Unknown

Last updated

2020-01-06

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

Conditions

Actinic keratosis, in situ skin carcinoma Skin and Connective Tissue Diseases

Interventions

A Piroxicam-based sunscreen 50+ The intervention involves the application of the evaluated cream twice daily on the target area, using one Finger-Tip-Unit (0.5 g) for the treatment of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 or above 2.Presence of multiple AK lesions on the face or scalp

Exclusion criteria

Exclusion criteria: 1. Recently received previous treatments interfering with the evaluation of the treatment area (topical medications, immunosuppressive or immunomodulating agents, phototherapy, oral retinoids, or other therapies for AKs). 2. Pregnant or breast-feeding.

Design outcomes

Primary

Measure	Time frame
Clinical evolution of AK lesions number on a target zone area defined as the area with the highest number of AK lesions. Lesion count was assessed with an assessor-blinded approach evaluating digital color high definition images performed at each visit and coded in a blinded fashion at baseline, month 3 (week 12) and month 6 (week 24).	—

Secondary

Measure	Time frame
1. Reflectance confocal microscopy (RCM) calculated assessing 11-item with examination of stratum corneum, granular, spinous and derma layers: Disruption of keratinocytes, Parakeratosis, Polygonal keratinocytes, atypical honeycomb, inflammatory cells, round nucleated cells, curled fibers, collagen alteration, increased vascularity, dermal inflammation, melanophages) at baseline, month 3 (week 12) and month 6 (week 24). 2. Dermoscopy score (DS) features of the target lesion performed assessing erythema, scaling, pigmentation, and follicular plug, using a 5-point score (from 0 to 4 for each item; maximum score: 16) at baseline and month 6 (week 24).	—

Measure

Time frame

1. Reflectance confocal microscopy (RCM) calculated assessing 11-item with examination of stratum corneum, granular, spinous and derma layers: Disruption of keratinocytes, Parakeratosis, Polygonal keratinocytes, atypical honeycomb, inflammatory cells, round nucleated cells, curled fibers, collagen alteration, increased vascularity, dermal inflammation, melanophages) at baseline, month 3 (week 12) and month 6 (week 24). 2. Dermoscopy score (DS) features of the target lesion performed assessing erythema, scaling, pigmentation, and follicular plug, using a 5-point score (from 0 to 4 for each item; maximum score: 16) at baseline and month 6 (week 24).

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Countries

Italy

Contacts

Public ContactMassimo Milani

massimo.milani@difacooper.com+39029659031

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026