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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929719
• Other study ID #: DPSG 1518, 1216
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2016
• Last updated: May 3, 2017
• Start date: April 2014
• Est. completion date: June 2016

Study information

• Verified date: May 2017
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Therapeutic equivalence and safety study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1134
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Test.
gel
• Aczone Gel 5%
gel
• Placebo
gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inflammatory lesion count		baseline to week 12 (study day 84)
Primary	Change in non-inflammatory lesion count		baseline to week 12 (study day 84)