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Also known as Diclofenac sodium, Solaraze®
Diclofenac · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Diclofenac Sodium Gel, 3% | EXPERIMENTAL | Diclofenac Sodium Gel, 3%, applied twice daily for 60 days |
| Solaraze® | ACTIVE_COMPARATOR | Solaraze® (diclofenac sodium) Gel, 3%, applied twice daily for 60 days |
| Vehicle of Test Product | PLACEBO_COMPARATOR | Vehicle of Test Product, Gel, applied twice daily for 60 days |
| Name | Type | Description |
|---|---|---|
| Diclofenac sodium | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Willing and able to provide written informed consent for the study. * At least 18 years of age * Immunocompetent male or nonpregnant and nonlactating female. Each female subject of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at l...
Diclofenac is being developed as a topical treatment for actinic keratosis, a skin condition involving rough, scaly patches caused by sun damage. It is applied as a gel to affected areas such as the face or bald scalp. The formulation under study is a 3% diclofenac sodium gel.
Diclofenac targets the enzymes PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. It acts as an inhibitor of these targets. By inhibiting these enzymes, diclofenac affects the production of prostaglandins, which are involved in inflammation and other processes.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is developing this diclofenac sodium gel formulation. The company is the sponsor of the clinical program evaluating the drug in actinic keratosis.
Diclofenac is in Phase 3 clinical development for actinic keratosis. It is an investigational product and has not been approved by the FDA for this indication. The Phase 3 trial has been completed.
Diclofenac has been studied in one Phase 3 trial, NCT02611804, titled A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp. The trial enrolled 492 participants in the United States and is completed.
Yes, Diclofenac sodium is another name for Diclofenac. The two names refer to the same active ingredient. The formulation being developed for actinic keratosis is specifically diclofenac sodium gel, 3%.