Efficacy of different photoprotection strategies in preventing actinic keratosis recurrence after photodynamic therapy

The ATHENA Trial: Actixicam after photo-dynamic therapy for multiple actinic keratosis lesions. A randomized open-label assessor-masked outcome evaluation superiority trial vs. standard care in actinic keratosis subjects after phtotodynamic therapies

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16168548

Enrollment

Registered

2018-05-21

Start date

2017-03-01

Completion date

Unknown

Last updated

2020-05-11

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

Conditions

Actinic keratosis recurrence after photodynamic therapy Skin and Connective Tissue Diseases Actinic keratosis

Interventions

Randomization was performed using a randomization list with an allocation ratio of 1:1. Actixicam: sunscreen SPF50+ and piroxicam 0.8% cream formulation, applied twice daily 0.5 g (1 f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. At least 6 AK lesions (scalp or face) suitable for PDT treatment 2. Aged >18 years 3. Willing to participate in the trial (giving written informed consent)

Exclusion criteria

Exclusion criteria: 1. Other acute skin diseases other than AK 2. Known allergy to one of the components of products used in the trial

Design outcomes

Primary

Measure	Time frame
Clinical count (assessor masked for allocation treatments) of actinic keratosis lesions 6 months after last PDT session	—

Secondary

Measure	Time frame
Local tolerability (patient’s self-reported complaints e.g. burning, itching etc) will be evaluated at visit 2 (1 month after baseline visit), at visit 2 (3 months after baseline) and at visit 3 (6 months after baseline)	—

Countries

Italy

Contacts

Public ContactMassimo Milani

massimo.milani@difacooper.com+39029659031

Outcome results

None listed

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