Use of sunscreens with DNA repair components are more efficacious that sunscreen only in improving keratosis actinica patients clinical outcome after photodynamic therapy

A 9-month, randomised, assessor-blinded parallel-group study to evaluate clinical effects of a film-forming medical devices containing photolyase in the treatment of cancerization field in comparison with sunscreen in patients after successful photodynamic therapy for actinic keratosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12347628

Enrollment

Registered

2015-11-05

Start date

2014-01-01

Completion date

Unknown

Last updated

2020-06-08

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

Patients are randomised to be treated with either: 1. A film-forming class II medical device containing photolyase, a DNA-repairing enzyme, with a high broad photo-protection action (E

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Presence of at least 5 AK lesions on the scalp

Exclusion criteria

Exclusion criteria: 1. Presence of non-melanoma skin cancer lesions 2. Allergy to one of the components of study products 3. Xerodema pigmentosum

Design outcomes

Primary

Measure	Time frame
Evolution of AK lesions after successful PDT, evaluated at baseline and at 1, 3 6 and 9 months after PDT	—

Secondary

Measure	Time frame
Need for additional PDT procedure, evaluated at baseline and at 1, 3 6 and 9 months after PDT	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026