Effects of Topical Diclofenac on Tumor Metabolism

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The rationale of this study is to investigate the effects of topical diclofenac on tumor metabolism in the treatment of actinic keratoses in immunocompetent and immunocompromised patients.

Study hypothesis is that topical diclofenac lowers lactate level in skin biopsies of actinic keratoses. Planned number of patients is 38.

This study is a monocenter study investigating the effects of 3% diclofenac in 2.5% hyaluronic acid gel on tumor metabolism in the treatment of actinic keratoses. Treatment duration is 3 months. Skin biopsies will be obtained before treatment, at the end of the treatment and four weeks after the treatment. Control biopsies at visit 1 and 3 are performed in healthy, sun damaged and untreated skin. Evaluation of efficacy will be performed at the end of the treatment and four weeks after the treatment.

Duration of treatment is 3 months (±4 weeks). Approximately 0,5g Solaraze® 3% gel is applied on a 5cm x 5cm lesion. Solaraze® 3% gel is applied twice daily on the study lesions.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Regensburg
• Collaborator: German Research Foundation
• Treatments: Diclofenac; Hyaluronic Acid

Criteria

Inclusion Criteria:

• Written informed consent has been signed prior to or at Screening Visit

• Caucasian male and female patients

• Age > 18 years

• Negative pregnancy test in women of childbearing age

• Clinical diagnosis of actinic keratosis (AK)

• A minimum of three AK lesions

Exclusion Criteria in immunocompromised patients :

• Concomitant UV-phototherapy

• Pregnancy or lactation

• Women in child-bearing age who do not use highly efficient contraceptive methods (<1% failure rate per year)

• Skin diseases that might interfere with response evaluation of study treatment

• Topical pretreatment of the AK study lesions with photodynamic therapy, Solaraze® 3% gel, Aldara®, 5-FU, or polyphenon E during the 8 weeks preceding study treatment

• Radiation therapy performed in the treatment area during the 3 months preceding study therapy

• Systemic treatment with diclofenac

• Known intolerance to diclofenac or to any other ingredient of Solaraze® 3% gel

• Conditions that might interfere with the ability to understand the study and thus give written informed consent

• Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion

• Suspected lack of compliance

Exclusion criteria in immunocompetent patients:

• Concomitant UV-phototherapy

• Pregnancy or lactation

• Women in child-bearing age who do not use highly efficient contraceptive methods (<1% failure rate per year)

• Patients with clinically relevant suppression of the immune system (e.g. drug induced, infection)

• Skin diseases that might interfere with response evaluation of study treatment

• Topical pretreatment of the AK study lesions with photodynamic therapy, Aldara®, Solaraze® 3% gel , 5-FU, or polyphenon E during the 8 weeks preceding study treatment

• Systemic treatment with cytostatic drugs or radiation therapy performed in the treatment area during the 3 months preceding study therapy

• Systemic treatment with diclofenac

• Known intolerance to diclofenac or to any other ingredient of Solaraze® 3% gel

• Conditions that might interfere with the ability to understand the study and thus give written informed consent

• Simultaneous participation in another clinical study or participation in another clinical study in participation in another clinical study in the 30 days directly preceding inclusion

• Suspected lack of compliance