NCT03427554 is a EARLY_PHASE1 clinical trial of Tretinoin cream 0.1% in Acne Vulgaris, sponsored by Sun Pharmaceutical Industries, Inc..

Who is sponsoring NCT03427554?

NCT03427554 is sponsored by Sun Pharmaceutical Industries, Inc..

What drugs are being tested in NCT03427554?

Interventions in NCT03427554: Tretinoin cream 0.1%, RETIN-A® Cream, Vehicle of the test product.

What condition does NCT03427554 study?

NCT03427554 studies Acne Vulgaris.

Is NCT03427554 still recruiting?

NCT03427554 is currently completed. Last updated 18 May 2018.

Last reviewed 2018-05-18 · How we verify

NCT03427554

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

To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris

Completed EARLY_PHASE1 Last updated 18 May 2018

What this trial tests

EARLY_PHASE1 trial testing Tretinoin cream 0.1% in Acne Vulgaris in 455 participants. Completed in 26 January 2018.

Timeline

21 August 2017

Primary endpoint
26 January 2018

26 January 2018

Quick facts

Lead sponsor	Sun Pharmaceutical Industries, Inc.
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	455
Start date	21 August 2017
Primary completion	26 January 2018
Estimated completion	26 January 2018
Sites	1 location across United States

Drugs / interventions tested

Tretinoin cream 0.1% — full drug profile →
RETIN-A® Cream — full drug profile →
Vehicle of the test product — full drug profile →

Conditions studied

Acne Vulgaris — all drugs for Acne Vulgaris →

Sponsor

Sun Pharmaceutical Industries, Inc. — full company profile →

Who can join

Adults 12 to 40, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.

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 Tretinoin cream 0.1%

Trials testing the same drug.

NCT07366229 — Topical Application of Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne · Phase 2 · recruiting

Other recruiting trials for Acne Vulgaris

Currently open trials in the same condition.

NCT07341087 — Skin Inflammation in Perimenopause: A Probiotic Intervention Proof of Concept Trial · NA · recruiting
NCT07474883 — Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris · EARLY_PHASE1 · recruiting
NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
NCT07056673 — Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study · NA · recruiting
NCT07102186 — Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris · Phase 4 · recruiting

Other Sun Pharmaceutical Industries, Inc. trials

Trials by the same sponsor.

NCT07469228 — A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne V · Phase 1 · completed
NCT06733402 — A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENC · Phase 1 · completed
NCT06673641 — A Study Comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% (Taro Pharmaceutica · Phase 1 · completed
NCT06305637 — A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor. · Phase 1 · completed
NCT06673654 — A Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream for · Phase 1 · 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 NCT03427554 (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 Sun Pharmaceutical Industries, Inc.
Last refreshed: 18 May 2018

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/NCT03427554.

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