NCT03826550 is a Phase 3 clinical trial of Diclofenac Sodium Gel in Actinic Keratoses, sponsored by Encube Ethicals Pvt. Ltd..

Who is sponsoring NCT03826550?

NCT03826550 is sponsored by Encube Ethicals Pvt. Ltd..

What drugs are being tested in NCT03826550?

Interventions in NCT03826550: Diclofenac Sodium Gel, Solaraze 3% Topical Gel, Placebo.

What condition does NCT03826550 study?

NCT03826550 studies Actinic Keratoses.

Is NCT03826550 still recruiting?

NCT03826550 is currently completed. Last updated 1 February 2019.

Last reviewed 2019-02-01 · How we verify

NCT03826550

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 1 February 2019

What this trial tests

Phase 3 trial testing Diclofenac Sodium Gel in Actinic Keratoses in 655 participants. Completed in 3 July 2018.

Timeline

12 January 2018

Primary endpoint
30 June 2018

3 July 2018

Quick facts

Lead sponsor	Encube Ethicals Pvt. Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	655
Start date	12 January 2018
Primary completion	30 June 2018
Estimated completion	3 July 2018
Sites	24 locations across United States

Drugs / interventions tested

Diclofenac Sodium Gel — full drug profile →
Solaraze 3% Topical Gel — full drug profile →
Placebo

Conditions studied

Actinic Keratoses — all drugs for Actinic Keratoses →

Sponsor

Encube Ethicals Pvt. Ltd. — full company profile →

Who can join

18 and older, any sex, with Actinic Keratoses. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Diclofenac Sodium Gel

Trials testing the same drug.

NCT07101016 — Effect of Local Use of Non-steroidal Anti-inflammatory Agent (Diclofenac Sodium) With and Without Hyaluronidase on Post- · NA · not yet recruiting
NCT06905561 — Topical Diclofenac for Prevention of Radiation-induced Dermatitis · NA · recruiting
NCT06307106 — Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study · NA · completed
NCT05968482 — Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in H · Phase 1 · completed
NCT04511195 — Effectiveness and Safety of Sphaeralcea Angustifolia Standardized Extract as a Topical Treatment of Knee Osteoarthritis · Phase 2 · unknown

Other recruiting trials for Actinic Keratoses

Currently open trials in the same condition.

NCT06499415 — Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis · Phase 4 · recruiting
NCT06385340 — Investigation of the Effect of Lipikar Baume AP+M · NA · recruiting
NCT06321003 — SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography · recruiting
NCT05202860 — Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis · Phase 2 · active not recruiting
NCT05976061 — High- and Low-risk Actinic Keratosis Referrals to Secondary Care · active not recruiting

Other Encube Ethicals Pvt. Ltd. trials

Trials by the same sponsor.

NCT05078827 — Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of MylanPharmaceuticals In · Phase 3 · completed
NCT03824912 — Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis · Phase 3 · completed
NCT03178942 — Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03826550 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Encube Ethicals Pvt. Ltd.
Last refreshed: 1 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03826550.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing