A Novel Combination Oral Agent to Treat Acne Vulgaris
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL ORAL ACNE TREATMENT FOR THE TREATMENT OF ACNE VULGARIS
1 other identifier
interventional
60
1 country
2
Brief Summary
The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2010
2 active sites
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
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFebruary 23, 2011
February 1, 2011
10 months
February 16, 2011
February 18, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The mean number of Inflammatory Lesions on the face at the beginning and end of treatment
The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment.
12 weeks
Secondary Outcomes (1)
The mean number of Comedones will be evaluated at the beginning and end of treatment
12 weeks
Study Arms (2)
Oral antibiotic plus soy extract
ACTIVE COMPARATOROral antibiotic
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy females 13 years of age or older
- Non-pregnant, non-lactating females
- Signed written informed consent form
- Must be able to understand and be willing to follow all study instructions
- Have a clinical diagnosis of acne vulgaris
You may not qualify if:
- Female subjects who are pregnant or nursing
- Any concomitant dermatologic condition that may affect outcome measures
- Concurrent use of any other medication to treat acne vulgaris
- Have a history or clinical evidence of any other active acute or chronic medical disease or condition considered by the principal investigator as unsuitable for the study
- Are currently using any other investigational agent or device
- Have participated in any other clinical study within 90 days prior to enrollment
- Employees or family members of sponsor or research site
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Palos Verdes Dermatology Associates
Rolling Hills Estates, California, 90274, United States
Berlin Center
Boynton Beach, Florida, 33437, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua M Berlin, MD
Study Protocol, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 16, 2011
First Posted
February 23, 2011
Study Start
November 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
February 23, 2011
Record last verified: 2011-02