A Novel Combination Oral Agent to Treat Acne Vulgaris

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Nexgen Dermatologics, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nexgen Dermatologics, Inc.
ClinicalTrials.gov Identifier:
NCT01301586
First received: February 16, 2011
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females


Condition Intervention Phase
ACNE VULGARIS
Drug: Doxycycline and S-equol
Drug: Doxycycline
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Nexgen Dermatologics, Inc.:

Primary Outcome Measures:
  • The mean number of Inflammatory Lesions on the face at the beginning and end of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment.


Secondary Outcome Measures:
  • The mean number of Comedones will be evaluated at the beginning and end of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    A trained investigator will count the number of comedones at the beginning and end of treatment.


Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   13 Years to 60 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301586

Contacts
Contact: H G Berlin, ESQ 561-739-5252 garyberlin17@hotmail.com

Locations
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
Principal Investigator: Joshua M Berlin, MD Study Protocol, Inc.
  More Information

No publications provided

Responsible Party: H. Gary Berlin, Nexgen Dermatologics, Inc.
ClinicalTrials.gov Identifier: NCT01301586     History of Changes
Other Study ID Numbers: 11022006
Study First Received: February 16, 2011
Last Updated: February 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014