Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Test Gel, 5% to ACZONE Gel, 5% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02929719

Enrollment

1134

Registered

2016-10-11

Start date

2014-04-30

Completion date

2016-06-30

Last updated

2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Brief summary

Therapeutic equivalence and safety study

Detailed description

To evaluate the therapeutic equivalence and safety of Test formulation and marketed Reference Listed Drug (RLD). To demonstrate the superiority of efficacy of the Test and Reference products over the placebo control in the treatment. To compare the safety of Test, Reference and Placebo treatments.

Interventions

DRUGTest.

gel

DRUGAczone Gel 5%

gel

DRUGPlacebo

gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris * Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below)

Exclusion criteria

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

Design outcomes

Primary

Measure	Time frame
Change in inflammatory lesion count	baseline to week 12 (study day 84)
Change in non-inflammatory lesion count	baseline to week 12 (study day 84)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026