We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Novel Combination Oral Agent to Treat Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01301586
Recruitment Status : Unknown
Verified February 2011 by Nexgen Dermatologics, Inc..
Recruitment status was:  Recruiting
First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
Nexgen Dermatologics, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females

Condition or disease Intervention/treatment Phase
ACNE VULGARIS Drug: Doxycycline and S-equol Drug: Doxycycline Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Oral antibiotic plus soy extract Drug: Doxycycline and S-equol
Oral doxycycline and s-equol twice a day
Active Comparator: Oral antibiotic Drug: Doxycycline
ORAL DOXYCYCLINE TWICE A DAY


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The mean number of Inflammatory Lesions on the face at the beginning and end of treatment [ Time Frame: 12 weeks ]
    The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment.


Secondary Outcome Measures :
  1. The mean number of Comedones will be evaluated at the beginning and end of treatment [ Time Frame: 12 weeks ]
    A trained investigator will count the number of comedones at the beginning and end of treatment.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301586


Contacts
Layout table for location contacts
Contact: H G Berlin, ESQ 561-739-5252 garyberlin17@hotmail.com

Locations
Layout table for location information
United States, California
Palos Verdes Dermatology Associates Recruiting
Rolling Hills Estates, California, United States, 90274
Contact: Howard Fein, MD    310-541-7800      
Principal Investigator: HOWARD FEIN, MD         
United States, Florida
Berlin Center Recruiting
Boynton Beach, Florida, United States, 33437
Contact: H G Berlin, ESQ    561-739-5252    garyberlin17@hotmail.com   
Principal Investigator: Joshua M Berlin, MD         
Sponsors and Collaborators
Nexgen Dermatologics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Joshua M Berlin, MD Study Protocol, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: H. Gary Berlin, Nexgen Dermatologics, Inc.
ClinicalTrials.gov Identifier: NCT01301586    
Other Study ID Numbers: 11022006
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
 Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents