Efficacy Study in Patients With Acne Vulgaris.
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
1 other identifier
interventional
294
0 countries
N/A
Brief Summary
Safety and efficacy study in patients with acne vulgaris
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2016
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2016
CompletedFirst Submitted
Initial submission to the registry
October 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2017
CompletedResults Posted
Study results publicly available
September 18, 2018
CompletedOctober 18, 2018
September 1, 2018
4 months
October 12, 2016
August 21, 2018
September 21, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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)
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)
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)
Study Arms (2)
ADPS topical product
EXPERIMENTALA thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
Placebo Control
PLACEBO COMPARATORA thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male or non pregnant female aged ≥ 9 years with a clinical diagnosis of acne vulgaris
You may not qualify if:
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager, Clinical Research
- Organization
- Taro Pharmaceuticals U.S.A., Inc.
Study Officials
- STUDY CHAIR
Catawba Research
http://catawbaresearch.com/contact/
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2016
First Posted
October 17, 2016
Study Start
October 3, 2016
Primary Completion
January 24, 2017
Study Completion
March 21, 2017
Last Updated
October 18, 2018
Results First Posted
September 18, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share