Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03132194
• Other study ID #: DPSG-1517
• Status: Completed
• Phase: Phase 1
• First received: March 16, 2017
• Last updated: May 3, 2017
• Start date: August 8, 2016
• Est. completion date: January 30, 2017

Study information

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

Clinical Trial Summary

To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.

Description:

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1125
• Est. completion date: January 30, 2017
• Est. primary completion date: January 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Healthy male or non pregnant female aged = 12 years with a clinical diagnosis of acne vulgaris.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• DPSG 7.5%
topical gel
• Aczone
topical gel
• Placebo
topical 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 counts	Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts	12 weeks
Primary	Change in non-inflammatory lesion counts	Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts	12 weeks
Secondary	Clinical response of success	The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment	12 weeks