NCT03826550

Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs Solaraze ® in the Treatment of Actinic Keratosis

A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Encube Ethicals) Compared to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharmaceuticals Inc.) in the Treatment of Actinic Keratosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 655 (actual)
• Sponsor: Encube Ethicals Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Therapeutic Equivalence of Diclofenac Sodium Gel 3% and Solaraze ®, in the treatment of Actinic Keratosis

Detailed description

A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Encube Ethicals) Compared to Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharmaceuticals Inc.) in the Treatment of Actinic Keratosis

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium Gel	Twice daily for 60 days. Each patient is expected to receive 120 doses
DRUG	Solaraze 3% Topical Gel	Twice daily for 60 days. Each patient is expected to receive 120 doses
OTHER	Placebo	Twice daily for 60 days. Each patient is expected to receive 120 doses

Timeline

• Start date: 2018-01-12
• Primary completion: 2018-06-30
• Completion: 2018-07-03
• First posted: 2019-02-01
• Last updated: 2019-02-01

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study