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Actinic Keratoses | Effects of Topical Diclofenac on Tumor Metabolism

Actinic Keratoses research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Actinic Keratoses

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:3% diclofenac in 2.5% hyaluronic acid gel

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Diclofenac3 % diclofenac in 2.5% hyaluronic acid gel (Solaraze® 3% gel) is applied twice daily in the treatment area. 3 % diclofenac in 2.5% hyaluronic acid gel (Solaraze® 3% gel) is to be applied 1cm beyond the single AK.

Study Status

Completed

Start Date: June 2013

Completed Date: March 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Lactate level in skin biopsies of actinic keratoses

Secondary Outcome: Lactate level in skin biopsies of healthy skin in a subpopulation

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University Hospital Regensburg

Collaborator: German Research Foundation

More information:https://clinicaltrials.gov/show/NCT01935531

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