Evaluation of diclofenac for pain reduction during photodynamic therapy

Placebo-controlled cross-over study on the efficacy of a non-steroidal antirheumatic drug for pain reduction during photodynamic therapy of actinic keratoses

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004403-13-AT

Enrollment

Unknown

Registered

2013-08-08

Start date

2013-08-27

Completion date

Unknown

Last updated

2017-01-23

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

Conditions

actinic keratosis

Interventions

Trade Name: Voltaren 50 mg rapid Product Name: Voltaren 50 mg rapid Pharmaceutical Form: Capsule INN or Proposed INN: diclofenac potassium CAS Number: 15307-81-0 Other descriptive name: Diclofenac pot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with actinic keratoses on the head; age 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: intolerance to topically applied aminolevulinic acid; intolerance or allergy to diclofenac; florid and untreated gastric or duodenal ulcer

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the influence of a single dose of diclofenac on pain development during photodynamic therapy;Secondary Objective: to evaluate whether the methods used for pain reduction have an impact on the severity of the local skin reaction or the long-term response rates. in addition, to evaluate the cosmetic outcome and the patients`global satisfaction with the treatment;Primary end point(s): median pain score during and after PDT treatment;Timepoint(s) of evaluation of this end point: 1, 5, 9, 13 and 17 minutes after initiation of PDT and 10, 20 ad 30 minutes after end of treatment	—

Measure

Time frame

Main Objective: To evaluate the influence of a single dose of diclofenac on pain development during photodynamic therapy;Secondary Objective: to evaluate whether the methods used for pain reduction have an impact on the severity of the local skin reaction or the long-term response rates. in addition, to evaluate the cosmetic outcome and the patients`global satisfaction with the treatment;Primary end point(s): median pain score during and after PDT treatment;Timepoint(s) of evaluation of this end point: 1, 5, 9, 13 and 17 minutes after initiation of PDT and 10, 20 ad 30 minutes after end of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): - the intensity of the local skin reaction - the rate of complete response - rhe cosmetic outcome - patients` global satisfaction with the treatment;Timepoint(s) of evaluation of this end point: - immediately, 30 min, 2 and 7 days after PDT - 3, 6 and 12 months after PDT - 12 months after PDT - 12 months after PDT	—

Countries

Austria

Contacts

Public ContactSecretariat

Division of General Dermatology

00431404007702

Outcome results

None listed

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