Efficacy Study in Patients With Acne Vulgaris.

Acne Vulgaris Clinical Trial

Official title:

A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study to Evaluate the Efficacy and Safety of ADPS in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935036
• Other study ID #: ADPS 1602
• Status: Completed
• Phase: Phase 2
• Start date: October 3, 2016
• Est. completion date: March 21, 2017

Study information

• Verified date: September 2018
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety and efficacy study in patients with acne vulgaris

Description:

randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS in the treatment of acne vulgaris.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: March 21, 2017
• Est. primary completion date: January 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• Healthy male or non pregnant female aged = 9 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:
• ADPS topical product
topical product
• Placebo Control
topical product

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face		Baseline to week 12 (study day 84)
Primary	Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face		Baseline to week 12 (study day 84)
Primary	The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.	Success was defined as an IGA score that was at least two grades less than the baseline assessment.	Baseline to Week 12 (study day 84)