Effects of Topical Diclofenac on Tumor Metabolism

NCT01935531 | Completed Phase 4 DMC

• 1 other identifier: Diclo-TuMet_01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Actinic Keratoses

Keywords

actinic keratoses; tumor metabolism; glycolysis; diclofenac; warburg effect

Outcome Measures

Primary Outcomes (1)

• Lactate level in skin biopsies of actinic keratoses

  Assessment of the effects of topical 3% diclofenac in 2.5% hyaluronic acid gel on lactate level in skin biopsies of actinic keratoses. Skin biopsies of actinic keratoses are obtained prior to treatment and 4 weeks after the treatment.

  4 weeks after the treatment

Secondary Outcomes (3)

• Lactate level in skin biopsies of healthy skin in a subpopulation

  Before treatment and 4 weeks after the treatment

• Glycolysis-relevant proteins evaluated using PCR and Westernblot techniques

  at the end of the treatment and 4 weeks after the treatment

• Metabolic changes (e.g. glucose, amino acids)

  at the end of the tretment and 4 weeks after the treatment

Study Arms (1)

Diclofenac

EXPERIMENTAL

3 % 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.

Drug: 3% diclofenac in 2.5% hyaluronic acid gel

Interventions

3% diclofenac in 2.5% hyaluronic acid gel DRUG

Also known as: Solaraze Gel

Diclofenac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Suspected lack of compliance
• 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

Sponsors & Collaborators

• University Hospital Regensburg: lead
• German Research Foundation: collaborator

Study Sites (1)

University hospital Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Related Publications (1)

• Singer K, Dettmer K, Unger P, Schonhammer G, Renner K, Peter K, Siska PJ, Berneburg M, Herr W, Oefner PJ, Karrer S, Kreutz M, Datz E. Topical Diclofenac Reprograms Metabolism and Immune Cell Infiltration in Actinic Keratosis. Front Oncol. 2019 Jul 3;9:605. doi: 10.3389/fonc.2019.00605. eCollection 2019.

  PMID: 31334125 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: September 5, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

DE (1)