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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT03826550

Public ClinicalTrials.gov record NCT03826550. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 8:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT03826550
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Encube Ethicals Pvt. Ltd.
Industry
Enrollment
655 participants

Conditions and interventions

Interventions

  • Diclofenac Sodium Gel Drug
  • Solaraze 3% Topical Gel Drug
  • Placebo Other

Drug · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 11, 2018
Primary completion
Jun 29, 2018
Completion
Jul 2, 2018
Last update posted
Jan 31, 2019

2018

United States locations

U.S. sites
24
U.S. states
14
U.S. cities
23
Facility City State ZIP Site status
Dermatology Trial Associates Bryant Arkansas 71011
West Coast Research San Ramon California 94582
Universal Medical and Research Center, LLC Coral Gables Florida 33134
Solutions Through Advanced Research, Inc. Jacksonville Florida 32256
Health Awareness, Inc. Jupiter Florida 33458
Multi-Speciality Research Associates, Inc. Lake City Florida 32055
FXM Research Miami Florida 33175
FXM Research Miramar Miramar Florida 33027
Ormond Medical Arts Pharmaceutical Research Center Ormond Beach Florida 32174
Moore Clinical Research Tampa Florida 33618
Forward Clinical Trials Tampa Florida 33624
Northwest Clinical Trials Boise Idaho 82704
DS Research New Albany Indiana 47150
DS Research Louisville Kentucky 40241
Minnesota Clinical Study Center Fridley Minnesota 55432
DTRL, Inc. Henderson Nevada 89052
Dermatology Consulting Services High Point North Carolina 27262
Sterling Research Group Cincinnati Ohio 45246
DermDox Centers for Dermatology Hazleton Pennsylvania 18201
PEAK Research, LLC Upper Saint Clair Pennsylvania 15241
Anderson Dermatology Anderson South Carolina 29621
Greenville Dermatology, LLC Greenville South Carolina 29607
Sirius Clinical Research, LLC Austin Texas 78759
Health Research of Hampton Roads, Inc. Newport News Virginia 23606

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03826550, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 31, 2019 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03826550 live on ClinicalTrials.gov.

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