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A Novel Combination Oral Agent to Treat Acne Vulgaris

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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.

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 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
U.S. FDA Resources

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



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.



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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

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
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.

Responsible Party: H. Gary Berlin, Nexgen Dermatologics, Inc.
ClinicalTrials.gov Identifier: NCT01301586     History of Changes
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:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
Equol
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs