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NCT02411955
A Multiple-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to Tazorac® (Tazarotene Cream 0.1%) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Phase 1 trial testing Tazarotene Cream 0.1% in Acne Vulgaris in 1,077 participants. Completed in 1 February 2015.
1 January 2015
Quick facts
| Lead sponsor | Sun Pharmaceutical Industries, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 1,077 |
| Start date | 1 June 2014 |
| Primary completion | 1 January 2015 |
| Estimated completion | 1 February 2015 |
Drugs / interventions tested
- Tazarotene Cream 0.1%
- Tazorac®
- Placebo
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.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in inflammatory lesion counts
Time frame: Week 12
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts -
Change in non-inflammatory lesion counts
Time frame: Week 12
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Sponsor's own description
The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).
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:
- PubMed search for NCT02411955
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tazarotene Cream 0.1%
Trials testing the same drug.
- NCT03263624 — Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease · Phase 4 · unknown
- NCT02886715 — A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatme · Phase 3 · completed
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)
- Trial protocol + status: ClinicalTrials.gov NCT02411955 (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: 3 May 2017
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/NCT02411955.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing