Clinical trial · Interventional
Effects of Topical Diclofenac on Tumor Metabolism
Prospective, Controlled and Monocentric Study to Evaluate the Effects of Topical 3% Diclofenac in 2.5% Hyaluronic Acid Gel on Tumor Metabolism in the Treatment of Actinic Keratoses in Immunocompetent and Immunocompromised Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3% diclofenac in 2.5% hyaluronic acid gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diclofenac
- description
- 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.
- interventionNames
- Drug: 3% diclofenac in 2.5% hyaluronic acid gel
Primary outcomes (1)
- measure
- Lactate level in skin biopsies of actinic keratoses
- timeFrame
- 4 weeks after the treatment
- description
- 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.
Secondary outcomes (3)
- measure
- Lactate level in skin biopsies of healthy skin in a subpopulation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSinger 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