A Novel Combination Oral Agent to Treat Acne Vulgaris

February 18, 2011 updated by: Nexgen Dermatologics, Inc.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Rolling Hills Estates, California, United States, 90274
        • Recruiting
        • Palos Verdes Dermatology Associates
        • Contact:
          • Howard Fein, MD
          • Phone Number: 310-541-7800
        • Principal Investigator:
          • HOWARD FEIN, MD
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Recruiting
        • Berlin Center
        • Contact:
        • Principal Investigator:
          • Joshua M Berlin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nexgen Dermatologics, Inc.

Investigators

  • Principal Investigator: Joshua M Berlin, MD, Study Protocol, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 18, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11022006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ACNE VULGARIS

Clinical Trials on Doxycycline and S-equol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe