Phase 3
Completed N=1,110
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Source: ClinicalTrials.gov NCT02886715 ↗Enrolled (actual)
1,110
Serious AEs
0.1%
Results posted
Aug 2018
Primary outcomePrimary: Change in Inflammatory Lesion Counts — -58.44; -60.07; -53.28 percent change — p=0.0185
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Inflammatory Lesion Counts |
-58.44; -60.07; -53.28 | 0.0185 sig |
| PRIMARY Change in Non-inflammatory Lesion Counts |
-50.11; -51.99; -45.72 | 0.0354 sig |
| SECONDARY Clinical Response of Success |
20.0; 23.7; 15.2 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
- Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.
Exclusion Criteria
- Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
- Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.
Data sourced from ClinicalTrials.gov (NCT02886715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.